<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299101</url>
  </required_header>
  <id_info>
    <org_study_id>E2562-P</org_study_id>
    <secondary_id>I21RX002562</secondary_id>
    <nct_id>NCT03299101</nct_id>
  </id_info>
  <brief_title>Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery</brief_title>
  <official_title>Pilot Testing a Home-based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran&#xD;
      population grows older and more frail, there is a critical need to identify effective&#xD;
      strategies for reducing surgical risks for these patients. Prior research shows that&#xD;
      inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and&#xD;
      improve outcomes by building strength and improving nutrition. The investigators believe that&#xD;
      similar improvements may be obtained by using similar interventions before surgery to&#xD;
      &quot;prehabilitate&quot; patients' capacity to tolerate the stress of surgery. The proposed research&#xD;
      will examine the feasibility of a new, home-based prehabilitation intervention aimed at&#xD;
      improving surgical outcomes after cardiothoracic surgery through preoperative exercise&#xD;
      training and nutritional supplementation. Findings from the study will inform the design of a&#xD;
      larger randomized controlled trial of the prehabilitation intervention. If proven effective,&#xD;
      prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major&#xD;
      elective surgery each year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Frail Veterans are at increased risk for poor surgical outcomes. Although&#xD;
      surgical techniques have advanced to a level where surgery on very old adults is feasible, if&#xD;
      a patient is also frail, the stress of surgery may overwhelm their adaptive capacities,&#xD;
      placing them at increased risk of mortality, morbidity, and institutionalization even if&#xD;
      surgery is technically successful. Frailty is a clinical syndrome that is commonly&#xD;
      characterized by muscle atrophy, diminished strength and speed, decreased physical activity,&#xD;
      and exhaustion. It is independent of any specific disease, but it increases with age and&#xD;
      worsens disease prognoses by diminishing capacity to tolerate stressors. Thus, while surgery&#xD;
      is often indicated for older patients, frail candidates are less likely than robust&#xD;
      counterparts to tolerate the procedure and/or recover functional capacity. In fact, recent VA&#xD;
      data demonstrate that frailty is a more powerful predictor of increased perioperative&#xD;
      mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity&#xD;
      alone. As the Veteran and US populations grow older, frailty will increase, making it&#xD;
      critically important to identify effective strategies for improving the surgical recovery and&#xD;
      outcomes of frail patients.&#xD;
&#xD;
      &quot;Prehabilitation&quot; has the potential to improve surgical outcomes among the frail. Prior&#xD;
      research demonstrates that inter-disciplinary rehabilitation strategies deployed after&#xD;
      surgery enhance recovery and improve outcomes by building strength and improving nutrition.&#xD;
      Based on this success, there is growing interest in &quot;prehabilitation&quot;, which is a similar&#xD;
      intervention deployed before surgery. By modifying physiological and environmental risks,&#xD;
      prehabilitation aims to augment patients' capacity to compensate for the stress of surgery&#xD;
      itself and the convalescent period thereafter. Frail patients may benefit disproportionately&#xD;
      from prehabilitation because they have diminished capacity to endure the procedure and/or&#xD;
      recovery. Preliminary evidence suggests that preoperative exercise interventions improve&#xD;
      surgical outcomes. However, prehabilitation has not yet been studied in either Veteran or&#xD;
      specifically frail populations, and no prior studies used home-based prehabilitation&#xD;
      strategies to safely minimize travel-related barriers to participation.&#xD;
&#xD;
      Objectives: The investigators will examine the feasibility of a novel, multifaceted,&#xD;
      home-based prehabilitation intervention designed to improve functional capacity and&#xD;
      postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Specific aims&#xD;
      are to:&#xD;
&#xD;
        1. Estimate rates of recruitment, retention, and adherence to the intervention; and&#xD;
           evaluate participation barriers.&#xD;
&#xD;
        2. Measure changes over time in frailty, physical function, pulmonary function, nutrition,&#xD;
           and health-related quality of life at baseline, the day of surgery, and 30 and 90 days&#xD;
           after surgery.&#xD;
&#xD;
        3. Explore changes in postoperative mortality, major complications, length of hospital&#xD;
           stay, and level of independent living using case-matched historical controls.&#xD;
&#xD;
      Methods: This single-arm pilot study will enroll a consecutive cohort of up to 50 Veterans&#xD;
      identified as frail using a standardized frailty assessment and scheduled for major&#xD;
      cardiothoracic surgery at the VA Pittsburgh Healthcare System. The 4 week long&#xD;
      prehabilitation regimen will include: (a) aerobic conditioning, (b) strength and coordination&#xD;
      training, (c) respiratory muscle training, and (d) nutritional coaching and supplementation.&#xD;
      Pre- and post-prehabilitation assessments will include: (a) frailty; (b) physical function;&#xD;
      (c) pulmonary function; (d) nutrition; and (e) health-related quality of life. Postoperative&#xD;
      outcomes will include length of stay, mortality and complications. Compliance with the&#xD;
      prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will&#xD;
      inform a larger randomized controlled trial testing the prehabilitation intervention.&#xD;
      Findings will be relevant for the 42,000 frail Veterans scheduled for major elective surgery&#xD;
      each year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2017</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A novel a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Prehabilitation will include: (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment Rate</measure>
    <time_frame>Baseline</time_frame>
    <description>Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention Rate</measure>
    <time_frame>90 days postoperatively</time_frame>
    <description>Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence Rate</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Grip Strength Over the Course of Treatment and Recovery.</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Grip strength will be measured in kilograms of pressure using a Smedley grip dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Pulmonary function will be measured in terms of maximum MIP (maximal inspiratory pressure).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Pulmonary function will be measured in terms of mean maximal inspiratory pressure (MIP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Pulmonary function will be measured in terms of maximum MEP (maximal expiratory pressures)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Pulmonary function will be measured in terms of mean maximal expiratory pressures (MEP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Pulmonary function will be measured in terms of maximum sustained MIP (SMIP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Pulmonary function will be measured in terms of mean sustained MIP (SMIP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Prealbumin Over the Course of Treatment and Recovery</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Higher levels indicate greater levels of protein. Lower levels indicate the potential of inflammation. normal range is 18-41, Below 18 is lower than normal, above 41 is higher than normal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gait Speed Over the Course of Treatment and Recovery</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6 Minute Walk Test Over the Course of Treatment and Recovery</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>This standardized approach measures the distance in meters walked during 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health Related Quality of Life Over the Course of Treatment and Recovery</measure>
    <time_frame>Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively</time_frame>
    <description>Assessment of Quality of Life (AQoL-6D) survey. Scores range from 0 to 1. The higher the score, the better the quality of life.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Quality of Surgical Care Over the Course of Treatment and Recovery</measure>
    <time_frame>Day of Surgery and 30-days postoperatively</time_frame>
    <description>Agency for Healthcare Research and Quality (AHRQ) Surgical Care Survey (SCS) total communication section. Values are scored on a 3 point scale where 1 is good and 3 bad</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Coronary Artery Bypass Graft</condition>
  <condition>Non-cardiac Thoracic Surgery</condition>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Prehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prospective sample of patients anticipating cardiothoracic surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prehabilitation</intervention_name>
    <description>Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
    <arm_group_label>Prehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Veteran patient scheduled for Coronary artery bypass graft (CABG), valve surgery, or&#xD;
             other non-cardiac thoracic surgery;&#xD;
&#xD;
          2. Demonstrate at least mild frailty (e.g., Risk Analysis Index [RAI]&gt;=16).&#xD;
&#xD;
          3. Physician/provider request for patients with RAI&lt;16.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergent, urgent, or otherwise time-sensitive surgery that precludes prehabilitation;&#xD;
&#xD;
          -  Unstable or recent unstable cardiac syndrome as defined by (a) acute coronary syndrome&#xD;
             within 6 weeks; (b) decompensated heart failure; (c) New York Heart Association Class&#xD;
             IV Heart Failure; (d) unstable angina; (e) Canadian Cardiovascular Society Class IV&#xD;
             symptoms; (f) critical left main coronary disease; (g) clinically significant&#xD;
             arrhythmias,&#xD;
&#xD;
          -  Severe valvular heart disease: (a) severe aortic or mitral stenosis (aortic or mitral&#xD;
             valve area &lt;1.0 cm2 or mean gradient &gt;40 or &gt;10 mm Hg, respectively)&#xD;
&#xD;
          -  Dynamic LV (Left Ventricle) outflow obstruction&#xD;
&#xD;
          -  Physical, cognitive, social or logistical limitations preventing participation in the&#xD;
             prehabilitation regimen, including:&#xD;
&#xD;
          -  Patients who require surrogate consent for the planned surgery&#xD;
&#xD;
          -  Patients with court orders of incompetence or clinical determinations of incapacity&#xD;
             documented in the medical record&#xD;
&#xD;
          -  Clinical exam by study physician consistent with incapacity&#xD;
&#xD;
          -  Patients who at any time during prehabilitation or longitudinal follow up demonstrate&#xD;
             insufficient cognitive capacity to safely and effectively carry out the prescribed&#xD;
             activities.&#xD;
&#xD;
          -  Unable to speak English.&#xD;
&#xD;
          -  Surgery is cancelled by IMPACT clinic or surgeon due to unacceptable risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel E. Hall, MD MDiv MHSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <results_first_submitted>September 14, 2020</results_first_submitted>
  <results_first_submitted_qc>November 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2020</results_first_posted>
  <last_update_submitted>December 21, 2020</last_update_submitted>
  <last_update_submitted_qc>December 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Frailty</keyword>
  <keyword>Prehabilitation</keyword>
  <keyword>Exercise therapy</keyword>
  <keyword>Surgery</keyword>
  <keyword>Nutrition support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03299101/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Prehabilitation</title>
          <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Surgery was changed</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not enough time to complete prehab</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants that completed the baseline assessments were analyzed.</population>
      <group_list>
        <group group_id="B1">
          <title>Prehabilitation</title>
          <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.09" spread="7.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Risk Analysis Index</title>
          <description>This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.</description>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.85" spread="8.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Recruitment Rate</title>
        <description>Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.</description>
        <time_frame>Baseline</time_frame>
        <population>65 is the number of patients approached.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Recruitment Rate</title>
          <description>Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.</description>
          <population>65 is the number of patients approached.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Retention Rate</title>
        <description>Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.</description>
        <time_frame>90 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Retention Rate</title>
          <description>Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adherence Rate</title>
        <description>Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.</description>
        <time_frame>Day of surgery</time_frame>
        <population>All participants that self-reported their home training and/or showed their exercise or nutrition logs were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence Rate</title>
          <description>Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.</description>
          <population>All participants that self-reported their home training and/or showed their exercise or nutrition logs were analyzed.</population>
          <units>percentage of activities completed</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Home Strength/Aerobic/Transition Training</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.85" spread="28.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Home Breathing Training</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.30" spread="24.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Home Nutrition Log</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.09" spread="14.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Grip Strength Over the Course of Treatment and Recovery.</title>
        <description>Grip strength will be measured in kilograms of pressure using a Smedley grip dynamometer</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the hand grip assessment were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Grip Strength Over the Course of Treatment and Recovery.</title>
          <description>Grip strength will be measured in kilograms of pressure using a Smedley grip dynamometer</description>
          <population>All participants that completed the hand grip assessment were analyzed at each completed timepoint.</population>
          <units>kgf/cm2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Grip Strength</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.52" spread="9.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of Surgery Grip Strength</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.19" spread="7.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Days Post Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.13" spread="9.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in grip strength across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.872</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in grip strength between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.423</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.57</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.71</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in grip strength between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.853</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.12</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in grip strength between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.552</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.16</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP</title>
        <description>Pulmonary function will be measured in terms of maximum MIP (maximal inspiratory pressure).</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP</title>
          <description>Pulmonary function will be measured in terms of maximum MIP (maximal inspiratory pressure).</description>
          <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
          <units>cm of H2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Max MIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.42" spread="24.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery Max MIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.96" spread="24.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop Max MIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.82" spread="26.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in max MIP across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.256</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in maximum MIP between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.091</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>4.69</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.78</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in maximum MIP between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.066</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>6.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.69</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in maximum MIP between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.552</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.86</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.13</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP</title>
        <description>Pulmonary function will be measured in terms of mean maximal inspiratory pressure (MIP).</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP</title>
          <description>Pulmonary function will be measured in terms of mean maximal inspiratory pressure (MIP).</description>
          <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
          <units>cm of H2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Mean MIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.69" spread="23.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery Mean MIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.38" spread="23.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop Mean MIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.43" spread="26.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in mean MIP across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in mean MIP between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>7.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.48</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in mean MIP between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>10.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.61</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in mean MIP between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.290</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>2.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.18</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP</title>
        <description>Pulmonary function will be measured in terms of maximum MEP (maximal expiratory pressures)</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP</title>
          <description>Pulmonary function will be measured in terms of maximum MEP (maximal expiratory pressures)</description>
          <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
          <units>cm of H2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Max MEP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.09" spread="33.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery Max MEP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.81" spread="30.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop Max MEP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123.64" spread="32.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in maximal inspiratory pressure across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.009</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in maximum MEP between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>12.61</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.57</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in maximum MEP between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.015</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>12.79</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.25</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in maximum MEP between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.802</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.86</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.42</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP</title>
        <description>Pulmonary function will be measured in terms of mean maximal expiratory pressures (MEP).</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP</title>
          <description>Pulmonary function will be measured in terms of mean maximal expiratory pressures (MEP).</description>
          <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
          <units>cm of H2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Mean MEP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.48" spread="32.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery Mean MEP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.22" spread="28.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop Mean MEP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.01" spread="31.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in Mean MEP across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.010</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in mean MEP between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>12.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.35</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in mean MEP between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.042</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>9.95</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.90</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.221</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-3.77</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.08</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP</title>
        <description>Pulmonary function will be measured in terms of maximum sustained MIP (SMIP).</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP</title>
          <description>Pulmonary function will be measured in terms of maximum sustained MIP (SMIP).</description>
          <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
          <units>cm of H2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Max SMIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="416.55" spread="197.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery Max SMIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="434.48" spread="192.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop Max SMIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="466.77" spread="197.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in max SMIP across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.814</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in maximum SMIP between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.734</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>10.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>30.91</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in maximum SMIP between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.341</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>21.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>22.12</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in maximum SMIP between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.448</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>28.55</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>37.61</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP</title>
        <description>Pulmonary function will be measured in terms of mean sustained MIP (SMIP).</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP</title>
          <description>Pulmonary function will be measured in terms of mean sustained MIP (SMIP).</description>
          <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
          <units>cm of H2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Mean SMIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="364.36" spread="171.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery Mean SMIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="393.86" spread="185.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop Mean SMIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="435.94" spread="202.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in mean SMIP across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.419</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in mean SMIP between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.439</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>20.91</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>27.03</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in mean SMIP between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.069</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>47.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>26.19</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in mean SMIP between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.328</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>37.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>37.96</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Prealbumin Over the Course of Treatment and Recovery</title>
        <description>Higher levels indicate greater levels of protein. Lower levels indicate the potential of inflammation. normal range is 18-41, Below 18 is lower than normal, above 41 is higher than normal</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the blood draw were analyzed at each completed timepoint. Additionally, there was an error in the lab when processing the blood samples, this caused many samples to be evaluated incorrectly. Only correctly analyzed labs were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Prealbumin Over the Course of Treatment and Recovery</title>
          <description>Higher levels indicate greater levels of protein. Lower levels indicate the potential of inflammation. normal range is 18-41, Below 18 is lower than normal, above 41 is higher than normal</description>
          <population>All participants that completed the blood draw were analyzed at each completed timepoint. Additionally, there was an error in the lab when processing the blood samples, this caused many samples to be evaluated incorrectly. Only correctly analyzed labs were included in this analysis.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Serum Prealbumin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.27" spread="5.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery Serum Prealbumin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.50" spread="4.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop Serum Prealbumin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.13" spread="6.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in serum prealbumin across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.196</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in serum prealbumin between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.562</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in serum prealbumin between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.087</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.42</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.25</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in serum prealbumin between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.226</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.23</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gait Speed Over the Course of Treatment and Recovery</title>
        <description>Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the gait speed assessment were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gait Speed Over the Course of Treatment and Recovery</title>
          <description>Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters</description>
          <population>All participants that completed the gait speed assessment were analyzed at each completed timepoint.</population>
          <units>m/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Gait Speed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.16" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery Gait Speed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop Gait Speed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in gait speed across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in gait speed between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in gait speed between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.05</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in gait speed between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.874</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.05</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery</title>
        <description>This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the SPPB assessments were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery</title>
          <description>This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.</description>
          <population>All participants that completed the SPPB assessments were analyzed at each completed timepoint.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline SPPB</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.44" spread="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery SPPB</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.83" spread="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop SPPB</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.64" spread="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in SPPB across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.854</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in SPPB between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.298</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in SPPB between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.684</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.31</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in SPPB between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.485</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery</title>
        <description>This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the RAI assessment were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery</title>
          <description>This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.</description>
          <population>All participants that completed the RAI assessment were analyzed at each completed timepoint.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline RAI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.85" spread="8.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery RAI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.40" spread="8.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop RAI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.30" spread="9.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in RAI across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.067</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in RAI between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.089</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>2.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.22</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in RAI between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>4.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.60</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in RAI between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.221</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.98</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.62</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery</title>
        <description>This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the Subjective Global Assessment were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery</title>
          <description>This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.</description>
          <population>All participants that completed the Subjective Global Assessment were analyzed at each completed timepoint.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline SGA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.04" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of Surgery SGA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop SGA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.95" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in SGA across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.860</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in SGA between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.410</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in SGA between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.622</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in SGA between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.757</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 6 Minute Walk Test Over the Course of Treatment and Recovery</title>
        <description>This standardized approach measures the distance in meters walked during 6 minutes.</description>
        <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
        <population>All participants that completed the six minute walk test were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 6 Minute Walk Test Over the Course of Treatment and Recovery</title>
          <description>This standardized approach measures the distance in meters walked during 6 minutes.</description>
          <population>All participants that completed the six minute walk test were analyzed at each completed timepoint.</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline 6 Minute Walk Distance</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="366.49" spread="108.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of Surgery 6 Minute Walk Distance</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="400.33" spread="101.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop 6 Minute Walk Distance</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="386.96" spread="94.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change in 6 Minute Walk Test across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.362</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.203</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>25.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>20.06</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.357</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>12.70</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>13.77</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in 6 Minute Walk Test between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.163</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>21.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>15.40</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Health Related Quality of Life Over the Course of Treatment and Recovery</title>
        <description>Assessment of Quality of Life (AQoL-6D) survey. Scores range from 0 to 1. The higher the score, the better the quality of life.</description>
        <time_frame>Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively</time_frame>
        <population>All participants that completed all of the AQoL6D assessment were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Health Related Quality of Life Over the Course of Treatment and Recovery</title>
          <description>Assessment of Quality of Life (AQoL-6D) survey. Scores range from 0 to 1. The higher the score, the better the quality of life.</description>
          <population>All participants that completed all of the AQoL6D assessment were analyzed at each completed timepoint.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline AQoL6D Utility Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of surgery AQoL6D Utility Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Postop AQoL6D Utility Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change across all 4 time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.068</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change between baseline and day of surgery.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.043</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.02</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change between baseline and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.092</p_value>
            <p_value_desc>The null hypothesis was rejected a priori if p&lt;.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.02</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.292</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The null hypothesis was rejected a priori if p&lt;.05.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.02</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Quality of Surgical Care Over the Course of Treatment and Recovery</title>
        <description>Agency for Healthcare Research and Quality (AHRQ) Surgical Care Survey (SCS) total communication section. Values are scored on a 3 point scale where 1 is good and 3 bad</description>
        <time_frame>Day of Surgery and 30-days postoperatively</time_frame>
        <population>All participants that completed the every question of the AHRQ SCS total communication section assessment were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Surgical Care Over the Course of Treatment and Recovery</title>
          <description>Agency for Healthcare Research and Quality (AHRQ) Surgical Care Survey (SCS) total communication section. Values are scored on a 3 point scale where 1 is good and 3 bad</description>
          <population>All participants that completed the every question of the AHRQ SCS total communication section assessment were analyzed at each completed timepoint.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day of surgery Total Communication</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Postop Total Communication</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.13" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Linear mixed models estimated overall, within-person change across both time points.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.625</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prehabilitation</title>
          <description>Prospective sample of patients anticipating cardiothoracic surgery.&#xD;
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <description>Patient described slight chest discomfort and tingling to staff, staff noticed that patient was disoriented.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Unrelated inpatient hospitalization</sub_title>
                <description>Chest pain, shortness of breath, shaking chills after surgery</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Detox</sub_title>
                <description>Inpatient prior to surgery for detox.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post-operative pain unrealted inpatient hospitalization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Unrelated inpatient hospitalization</sub_title>
                <description>Hospitalization for shortness of breath</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Second unexpect surgery</sub_title>
                <description>Patient needed a second, unexpected surgery. Unrelated to this protocol.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Suspected ischemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Daniel E Hall</name_or_title>
      <organization>Pittsburgh VA Healthcare System, CHERP</organization>
      <phone>4123602016</phone>
      <email>daniel.hall2@va.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299101
org study id: E2562-P
secondary id: I21RX002562
nct id: NCT03299101
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran
      population grows older and more frail, there is a critical need to identify effective
      strategies for reducing surgical risks for these patients. Prior research shows that
      inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and
      improve outcomes by building strength and improving nutrition. The investigators believe that
      similar improvements may be obtained by using similar interventions before surgery to
      "prehabilitate" patients' capacity to tolerate the stress of surgery. The proposed research
      will examine the feasibility of a new, home-based prehabilitation intervention aimed at
      improving surgical outcomes after cardiothoracic surgery through preoperative exercise
      training and nutritional supplementation. Findings from the study will inform the design of a
      larger randomized controlled trial of the prehabilitation intervention. If proven effective,
      prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major
      elective surgery each year.
Background: Frail Veterans are at increased risk for poor surgical outcomes. Although
      surgical techniques have advanced to a level where surgery on very old adults is feasible, if
      a patient is also frail, the stress of surgery may overwhelm their adaptive capacities,
      placing them at increased risk of mortality, morbidity, and institutionalization even if
      surgery is technically successful. Frailty is a clinical syndrome that is commonly
      characterized by muscle atrophy, diminished strength and speed, decreased physical activity,
      and exhaustion. It is independent of any specific disease, but it increases with age and
      worsens disease prognoses by diminishing capacity to tolerate stressors. Thus, while surgery
      is often indicated for older patients, frail candidates are less likely than robust
      counterparts to tolerate the procedure and/or recover functional capacity. In fact, recent VA
      data demonstrate that frailty is a more powerful predictor of increased perioperative
      mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity
      alone. As the Veteran and US populations grow older, frailty will increase, making it
      critically important to identify effective strategies for improving the surgical recovery and
      outcomes of frail patients.

      "Prehabilitation" has the potential to improve surgical outcomes among the frail. Prior
      research demonstrates that inter-disciplinary rehabilitation strategies deployed after
      surgery enhance recovery and improve outcomes by building strength and improving nutrition.
      Based on this success, there is growing interest in "prehabilitation", which is a similar
      intervention deployed before surgery. By modifying physiological and environmental risks,
      prehabilitation aims to augment patients' capacity to compensate for the stress of surgery
      itself and the convalescent period thereafter. Frail patients may benefit disproportionately
      from prehabilitation because they have diminished capacity to endure the procedure and/or
      recovery. Preliminary evidence suggests that preoperative exercise interventions improve
      surgical outcomes. However, prehabilitation has not yet been studied in either Veteran or
      specifically frail populations, and no prior studies used home-based prehabilitation
      strategies to safely minimize travel-related barriers to participation.

      Objectives: The investigators will examine the feasibility of a novel, multifaceted,
      home-based prehabilitation intervention designed to improve functional capacity and
      postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Specific aims
      are to:

        1. Estimate rates of recruitment, retention, and adherence to the intervention; and
           evaluate participation barriers.

        2. Measure changes over time in frailty, physical function, pulmonary function, nutrition,
           and health-related quality of life at baseline, the day of surgery, and 30 and 90 days
           after surgery.

        3. Explore changes in postoperative mortality, major complications, length of hospital
           stay, and level of independent living using case-matched historical controls.

      Methods: This single-arm pilot study will enroll a consecutive cohort of up to 50 Veterans
      identified as frail using a standardized frailty assessment and scheduled for major
      cardiothoracic surgery at the VA Pittsburgh Healthcare System. The 4 week long
      prehabilitation regimen will include: (a) aerobic conditioning, (b) strength and coordination
      training, (c) respiratory muscle training, and (d) nutritional coaching and supplementation.
      Pre- and post-prehabilitation assessments will include: (a) frailty; (b) physical function;
      (c) pulmonary function; (d) nutrition; and (e) health-related quality of life. Postoperative
      outcomes will include length of stay, mortality and complications. Compliance with the
      prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will
      inform a larger randomized controlled trial testing the prehabilitation intervention.
      Findings will be relevant for the 42,000 frail Veterans scheduled for major elective surgery
      each year.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A novel a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Prehabilitation will include: (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Recruitment Rate
time frame: Baseline
description: Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
measure: Retention Rate
time frame: 90 days postoperatively
description: Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.
measure: Adherence Rate
time frame: Day of surgery
description: Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.
measure: Change in Grip Strength Over the Course of Treatment and Recovery.
time frame: Baseline, day of surgery, 90 days postoperatively
description: Grip strength will be measured in kilograms of pressure using a Smedley grip dynamometer
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP
time frame: Baseline, day of surgery, 90 days postoperatively
description: Pulmonary function will be measured in terms of maximum MIP (maximal inspiratory pressure).
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP
time frame: Baseline, day of surgery, 90 days postoperatively
description: Pulmonary function will be measured in terms of mean maximal inspiratory pressure (MIP).
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP
time frame: Baseline, day of surgery, 90 days postoperatively
description: Pulmonary function will be measured in terms of maximum MEP (maximal expiratory pressures)
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP
time frame: Baseline, day of surgery, 90 days postoperatively
description: Pulmonary function will be measured in terms of mean maximal expiratory pressures (MEP).
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP
time frame: Baseline, day of surgery, 90 days postoperatively
description: Pulmonary function will be measured in terms of maximum sustained MIP (SMIP).
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP
time frame: Baseline, day of surgery, 90 days postoperatively
description: Pulmonary function will be measured in terms of mean sustained MIP (SMIP).
measure: Serum Prealbumin Over the Course of Treatment and Recovery
time frame: Baseline, day of surgery, 90 days postoperatively
description: Higher levels indicate greater levels of protein. Lower levels indicate the potential of inflammation. normal range is 18-41, Below 18 is lower than normal, above 41 is higher than normal
measure: Change in Gait Speed Over the Course of Treatment and Recovery
time frame: Baseline, day of surgery, 90 days postoperatively
description: Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters
measure: Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery
time frame: Baseline, day of surgery, 90 days postoperatively
description: This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.
measure: Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
time frame: Baseline, day of surgery, 90 days postoperatively
description: This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.
measure: Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery
time frame: Baseline, day of surgery, 90 days postoperatively
description: This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.
measure: Change in 6 Minute Walk Test Over the Course of Treatment and Recovery
time frame: Baseline, day of surgery, 90 days postoperatively
description: This standardized approach measures the distance in meters walked during 6 minutes.
measure: Change in Health Related Quality of Life Over the Course of Treatment and Recovery
time frame: Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively
description: Assessment of Quality of Life (AQoL-6D) survey. Scores range from 0 to 1. The higher the score, the better the quality of life.
measure: Change in Quality of Surgical Care Over the Course of Treatment and Recovery
time frame: Day of Surgery and 30-days postoperatively
description: Agency for Healthcare Research and Quality (AHRQ) Surgical Care Survey (SCS) total communication section. Values are scored on a 3 point scale where 1 is good and 3 bad
arm group label: Prehabilitation
arm group type: Experimental
description: Prospective sample of patients anticipating cardiothoracic surgery.
intervention type: Other
intervention name: Prehabilitation
description: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
arm group label: Prehabilitation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Daniel E. Hall, MD MDiv MHSc
role: Principal Investigator
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Frailty
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 