<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/NCT03040336</url>
  </required_header>
  <id_info>
    <org_study_id>PPO 16-335</org_study_id>
    <secondary_id>HX-002345</secondary_id>
    <nct_id>NCT03040336</nct_id>
  </id_info>
  <brief_title>Piloting Prehabilitation Before Abdominal Surgery</brief_title>
  <official_title>Pilot Testing Prehabilitation Services Aimed at Improving Outcomes of Frail Veterans Following Major Abdominal 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. We believe that similar&#xD;
      improvements may be obtained by using similar interventions before surgery to &quot;prehabilitate&quot;&#xD;
      patients' capacity to tolerate the stress of surgery. The proposed research will examine the&#xD;
      feasibility of a new, prehabilitation intervention aimed at improving postoperative surgical&#xD;
      outcomes through preoperative exercise training and nutritional supplementation. Findings&#xD;
      from the study will inform the design of a larger randomized controlled trial of the&#xD;
      prehabilitation intervention. If proven effective, prehabilitation could benefit as many as&#xD;
      42,000 frail Veterans who are scheduled for major elective surgery each year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Frail Veterans are at increased risk for poor surgical outcomes. Although&#xD;
      surgeons operate safely on even the oldest old, if the elder is also frail, the stress of&#xD;
      surgery can result in significant mortality, morbidity, and institutionalization. Frailty is&#xD;
      a clinical syndrome marked by muscle atrophy, diminished strength, decreased physical&#xD;
      activity, and exhaustion. It is independent of any specific disease, but it increases with&#xD;
      age, and is a more powerful predictor of increased perioperative mortality, morbidity, length&#xD;
      of stay, and cost than predictions based on age or comorbidity alone. As the Veteran and US&#xD;
      populations grow older and more frail, it is critically important to identify effective&#xD;
      strategies for improving the surgical outcomes of these 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, improving nutrition, and&#xD;
      optimizing home supports. Based on this success, there is growing interest in deploying&#xD;
      similar interventions before surgery in what some call &quot;prehabilitation.&quot; By modifying&#xD;
      physiological and environmental risks, prehabilitation aims to augment patients' capacity to&#xD;
      compensate for the stress of both surgery and recovery. Frail patients will likely benefit&#xD;
      disproportionately from prehabilitation because they have the most diminished capacity to&#xD;
      adapt to the stress of surgery. However, prehabilitation has not yet been studied in either&#xD;
      Veteran or specifically frail populations.&#xD;
&#xD;
      Objectives: We will examine the feasibility of a novel, multifaceted pre-habilitation&#xD;
      intervention aimed at improving postoperative outcomes for frail Veterans undergoing major&#xD;
      abdominal surgery. Specific aims are to:&#xD;
&#xD;
        1. Estimate rates of recruitment, randomization, retention, and compliance with the&#xD;
           prehabilitation intervention;&#xD;
&#xD;
        2. Measure (a) physical performance, (b) pulmonary function, and (c) nutrition at baseline&#xD;
           and 2-week intervals to estimate changes over time and explore the optimal duration of&#xD;
           prehabilitation (2 vs. 4 vs. 6 weeks); and&#xD;
&#xD;
        3. Estimate overall and treatment-specific summary statistics for postoperative outcomes in&#xD;
           terms of 30- and 90-day (a) mortality, (b) major complications, (c) length of hospital&#xD;
           stay, (d) health-related quality of life, (e) quality of surgical care, and (f) change&#xD;
           in level of independent living.&#xD;
&#xD;
      Methods: This randomized 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 abdominal&#xD;
      surgery on the general or urological surgery services at the VA Pittsburgh Healthcare System.&#xD;
      We will randomize participants 1:1 to receive either: (1) standard preoperative optimization&#xD;
      by the Interdisciplinary Medical Preoperative Assessment Consultation &amp; Treatment Clinic&#xD;
      (IMPACT), or (2) prehabilitation + standard IMPACT optimization. The 6-week long&#xD;
      prehabilitation intervention will include (1) strength and balance training; (2) inspiratory&#xD;
      muscle training; and (3) nutritional coaching and supplementation. Assessments will include&#xD;
      standard postoperative outcomes as well as the Short Physical Performance Battery to measure&#xD;
      physical performance, Maximal Inspiratory Pressure to measure pulmonary function, and both&#xD;
      prealbumin and the 7-point Subjective Global Assessment to measure nutrition. Outcomes will&#xD;
      be assessed 30 or 90 days after surgery. Compliance with the prehabilitation regimen will be&#xD;
      assessed through patient logs and pedometers. Analyses will inform the development of a&#xD;
      larger randomized controlled trial testing the prehabilitation intervention. Findings will be&#xD;
      relevant for the as many as 42,000 frail Veterans scheduled for major elective surgery each&#xD;
      year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">December 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 28, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</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>Randomization Rate</measure>
    <time_frame>Baseline</time_frame>
    <description>Randomization rate will be expressed as the percentage of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention Rate</measure>
    <time_frame>Baseline to 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>Compliance Rate</measure>
    <time_frame>Baseline to Day of Surgery</time_frame>
    <description>Compliance rates will be expressed as the percentage of total compliance with assigned pehab activities actually completed by patients as recorded in home exercise and nutrition logs and completion of on site exercise sessions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Grip Strength</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Grip strength will be measured in kilograms of pressure using a Jamar grip dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Function</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Prealbumin</measure>
    <time_frame>Baseline, day of surgery, 90 days postoperatively</time_frame>
    <description>Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait Speed</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>Short Physical Performance Battery (SPPB)</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>Risk Analysis Index of Frailty (RAI)_questionnaire</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>7-point Subjective Global Assessment of Nutrition_questionnaire</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>
  <other_outcome>
    <measure>Postoperative Mortality</measure>
    <time_frame>30 and 90 days postoperatively</time_frame>
    <description>Postoperative mortality</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>Baseline, day of surgery, 90-days postoperatively</time_frame>
    <description>Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Surgical Care</measure>
    <time_frame>Day of Surgery and 30-days postoperatively</time_frame>
    <description>AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Prehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard of care + Prehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prehabilitation</intervention_name>
    <description>The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
    <arm_group_label>Prehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Frail as defined by an Risk Analysis Index (RAI) score &gt;=16&#xD;
&#xD;
          -  Scheduled for Major Abdominal Surgery as defined by a procedure that plans to violate&#xD;
             the peritoneum or retroperitoneum (excluding inguinal hernias)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to participate in planned Prehabilitation regimen&#xD;
&#xD;
          -  Surgery is cancelled by IMPACT clinic or surgeon due to unacceptable risk&#xD;
&#xD;
          -  Left ventricular ejection fractions &lt;35%&#xD;
&#xD;
          -  Severe valvular heart disease&#xD;
&#xD;
          -  Significant arrhythmia&#xD;
&#xD;
          -  Cognitive impairments that necessitate surrogate informed consent for the planned&#xD;
             surgery&#xD;
&#xD;
          -  Unable to speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</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>March 2020</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>January 28, 2020</results_first_submitted>
  <results_first_submitted_qc>March 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2020</results_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>surgery</keyword>
  <keyword>prehabilitation</keyword>
  <keyword>exercise therapy</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>April 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03040336/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>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Patient received the standard hospital care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prehabilitation</title>
          <description>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Patient received the standard hospital care</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="17"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </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="75.22" spread="7.48"/>
                    <measurement group_id="B2" value="71.71" spread="11.08"/>
                    <measurement group_id="B3" value="73.69" spread="7.86"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </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>54 is the number of patients approached. Only 17 were consented and overall analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Approached</title>
            <description>Patients approached to participate.</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>54 is the number of patients approached. Only 17 were consented and overall analyzed.</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="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Randomization Rate</title>
        <description>Randomization rate will be expressed as the percentage of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions</description>
        <time_frame>Baseline</time_frame>
        <population>17 participants were overall analyzed. 10 were randomized to prehab, 7 were randomized to standard of care.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>Randomization Rate</title>
          <description>Randomization rate will be expressed as the percentage of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions</description>
          <population>17 participants were overall analyzed. 10 were randomized to prehab, 7 were randomized to standard of care.</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="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </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>Baseline to 90 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</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="10"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Compliance Rate</title>
        <description>Compliance rates will be expressed as the percentage of total compliance with assigned pehab activities actually completed by patients as recorded in home exercise and nutrition logs and completion of on site exercise sessions.</description>
        <time_frame>Baseline to Day of Surgery</time_frame>
        <population>The compliance rate is only calculated for the prehabilitation arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Compliance Rate</title>
          <description>Compliance rates will be expressed as the percentage of total compliance with assigned pehab activities actually completed by patients as recorded in home exercise and nutrition logs and completion of on site exercise sessions.</description>
          <population>The compliance rate is only calculated for the prehabilitation arm.</population>
          <units>percentage of completed activities</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Home exercise log</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56" spread="42.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nutrition log</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" spread="31.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>On site exercise sessions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.6" spread="7.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Grip Strength</title>
        <description>Grip strength will be measured in kilograms of pressure using a Jamar 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>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>Grip Strength</title>
          <description>Grip strength will be measured in kilograms of pressure using a Jamar 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="10"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.38" spread="4.99"/>
                    <measurement group_id="O2" value="27.75" spread="11.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.00" spread="5.38"/>
                    <measurement group_id="O2" value="32.00" spread="13.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.75" spread="4.23"/>
                    <measurement group_id="O2" value="33.63" spread="11.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pulmonary Function</title>
        <description>Pulmonary function will be measured in terms of maximal inspiratory and 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>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>Pulmonary Function</title>
          <description>Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.</description>
          <population>All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.</population>
          <units>cm of water</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="7"/>
              </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="10"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.00" spread="27.20"/>
                    <measurement group_id="O2" value="79.33" spread="30.81"/>
                  </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="9"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.11" spread="29.75"/>
                    <measurement group_id="O2" value="90.00" spread="19.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Max MIP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.17" spread="32.00"/>
                    <measurement group_id="O2" value="100.00" spread="11.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Max MEP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.60" spread="34.97"/>
                    <measurement group_id="O2" value="114.67" spread="41.56"/>
                  </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="9"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.67" spread="35.22"/>
                    <measurement group_id="O2" value="112.33" spread="35.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Max MEP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.67" spread="30.50"/>
                    <measurement group_id="O2" value="102.75" spread="19.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Prealbumin</title>
        <description>Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.</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>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Prealbumin</title>
          <description>Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.</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="9"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Prealbumin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.5" spread="4.93"/>
                    <measurement group_id="O2" value="29" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of Surgery Prealbumin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" spread="6.36"/>
                    <measurement group_id="O2" value="25.5" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Prealbumin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.6" spread="8.44"/>
                    <measurement group_id="O2" value="22" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gait Speed</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>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>Gait Speed</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="10"/>
                <count group_id="O2" value="7"/>
              </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="10"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="0.30"/>
                    <measurement group_id="O2" value="1.54" spread="0.55"/>
                  </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="9"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.17"/>
                    <measurement group_id="O2" value="1.07" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Gait Speed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" spread="0.40"/>
                    <measurement group_id="O2" value="1.21" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short Physical Performance Battery (SPPB)</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>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>Short Physical Performance Battery (SPPB)</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="10"/>
                <count group_id="O2" value="7"/>
              </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="9"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.13" spread="2.30"/>
                    <measurement group_id="O2" value="10.6" spread="1.52"/>
                  </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="9"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.56" spread="0.88"/>
                    <measurement group_id="O2" value="11" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day SPPB</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="1.79"/>
                    <measurement group_id="O2" value="10.75" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Risk Analysis Index of Frailty (RAI)_questionnaire</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>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>Risk Analysis Index of Frailty (RAI)_questionnaire</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="10"/>
                <count group_id="O2" value="7"/>
              </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="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.57" spread="11.86"/>
                    <measurement group_id="O2" value="24.75" spread="0.50"/>
                  </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="7"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.86" spread="12.79"/>
                    <measurement group_id="O2" value="29.00" spread="5.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day RAI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.00" spread="10.39"/>
                    <measurement group_id="O2" value="26.67" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>7-point Subjective Global Assessment of Nutrition_questionnaire</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>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>7-point Subjective Global Assessment of Nutrition_questionnaire</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="10"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Subjective Global Assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.43" spread="0.79"/>
                    <measurement group_id="O2" value="6.4" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of Surgery Subjective Global Assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.14" spread="1.07"/>
                    <measurement group_id="O2" value="6.00" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Subjective Global Assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.14" spread="1.07"/>
                    <measurement group_id="O2" value="6.33" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Postoperative Mortality</title>
        <description>Postoperative mortality</description>
        <time_frame>30 and 90 days postoperatively</time_frame>
        <population>The mortality questionnaire was completed for all participants still enrolled in the study at the indicated time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Mortality</title>
          <description>Postoperative mortality</description>
          <population>The mortality questionnaire was completed for all participants still enrolled in the study at the indicated time point.</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="9"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30-days mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90-days mortality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Health Related Quality of Life</title>
        <description>Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.</description>
        <time_frame>Baseline, day of surgery, 90-days postoperatively</time_frame>
        <population>Not all participants were analyzed, because this measure requires participants to complete the questionnaire and not all participants did.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>Health Related Quality of Life</title>
          <description>Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.</description>
          <population>Not all participants were analyzed, because this measure requires participants to complete the questionnaire and not all participants did.</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="7"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72" spread="0.09"/>
                    <measurement group_id="O2" value="0.67" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.68" spread="0.08"/>
                    <measurement group_id="O2" value="0.77" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90-days postoperative</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="0.09"/>
                    <measurement group_id="O2" value="0.80" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Quality of Surgical Care</title>
        <description>AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.</description>
        <time_frame>Day of Surgery and 30-days postoperatively</time_frame>
        <population>All participants that completed the assessment were analyzed at each completed timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prehabilitation</title>
            <description>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Patient received the standard hospital care</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Surgical Care</title>
          <description>AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.</description>
          <population>All participants that completed the 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="9"/>
                <count group_id="O2" value="5"/>
              </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="9"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="0.37"/>
                    <measurement group_id="O2" value="1.13" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-days Total Communication</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" spread="0.29"/>
                    <measurement group_id="O2" value="1.19" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </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>Standard of care + Prehabilitation&#xD;
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Patient received the standard hospital care</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="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Unexpected and unrelated hospitalization</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Unexpected and unrelated death</sub_title>
                <description>Death due to prior diagnosis of lung cancer.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </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/NCT03040336
org study id: PPO 16-335
secondary id: HX-002345
nct id: NCT03040336
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. We 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, prehabilitation intervention aimed at improving postoperative surgical
      outcomes 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
      surgeons operate safely on even the oldest old, if the elder is also frail, the stress of
      surgery can result in significant mortality, morbidity, and institutionalization. Frailty is
      a clinical syndrome marked by muscle atrophy, diminished strength, decreased physical
      activity, and exhaustion. It is independent of any specific disease, but it increases with
      age, and 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 and more frail, it is critically important to identify effective
      strategies for improving the surgical outcomes of these 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, improving nutrition, and
      optimizing home supports. Based on this success, there is growing interest in deploying
      similar interventions before surgery in what some call "prehabilitation." By modifying
      physiological and environmental risks, prehabilitation aims to augment patients' capacity to
      compensate for the stress of both surgery and recovery. Frail patients will likely benefit
      disproportionately from prehabilitation because they have the most diminished capacity to
      adapt to the stress of surgery. However, prehabilitation has not yet been studied in either
      Veteran or specifically frail populations.

      Objectives: We will examine the feasibility of a novel, multifaceted pre-habilitation
      intervention aimed at improving postoperative outcomes for frail Veterans undergoing major
      abdominal surgery. Specific aims are to:

        1. Estimate rates of recruitment, randomization, retention, and compliance with the
           prehabilitation intervention;

        2. Measure (a) physical performance, (b) pulmonary function, and (c) nutrition at baseline
           and 2-week intervals to estimate changes over time and explore the optimal duration of
           prehabilitation (2 vs. 4 vs. 6 weeks); and

        3. Estimate overall and treatment-specific summary statistics for postoperative outcomes in
           terms of 30- and 90-day (a) mortality, (b) major complications, (c) length of hospital
           stay, (d) health-related quality of life, (e) quality of surgical care, and (f) change
           in level of independent living.

      Methods: This randomized pilot study will enroll a consecutive cohort of up to 50 Veterans
      identified as frail using a standardized frailty assessment and scheduled for major abdominal
      surgery on the general or urological surgery services at the VA Pittsburgh Healthcare System.
      We will randomize participants 1:1 to receive either: (1) standard preoperative optimization
      by the Interdisciplinary Medical Preoperative Assessment Consultation & Treatment Clinic
      (IMPACT), or (2) prehabilitation + standard IMPACT optimization. The 6-week long
      prehabilitation intervention will include (1) strength and balance training; (2) inspiratory
      muscle training; and (3) nutritional coaching and supplementation. Assessments will include
      standard postoperative outcomes as well as the Short Physical Performance Battery to measure
      physical performance, Maximal Inspiratory Pressure to measure pulmonary function, and both
      prealbumin and the 7-point Subjective Global Assessment to measure nutrition. Outcomes will
      be assessed 30 or 90 days after surgery. Compliance with the prehabilitation regimen will be
      assessed through patient logs and pedometers. Analyses will inform the development of a
      larger randomized controlled trial testing the prehabilitation intervention. Findings will be
      relevant for the as many as 42,000 frail Veterans scheduled for major elective surgery each
      year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
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: Randomization Rate
time frame: Baseline
description: Randomization rate will be expressed as the percentage of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions
measure: Retention Rate
time frame: Baseline to 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: Compliance Rate
time frame: Baseline to Day of Surgery
description: Compliance rates will be expressed as the percentage of total compliance with assigned pehab activities actually completed by patients as recorded in home exercise and nutrition logs and completion of on site exercise sessions.
measure: Grip Strength
time frame: Baseline, day of surgery, 90 days postoperatively
description: Grip strength will be measured in kilograms of pressure using a Jamar grip dynamometer
measure: Pulmonary Function
time frame: Baseline, day of surgery, 90 days postoperatively
description: Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.
measure: Serum Prealbumin
time frame: Baseline, day of surgery, 90 days postoperatively
description: Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.
measure: Gait Speed
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: Short Physical Performance Battery (SPPB)
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: Risk Analysis Index of Frailty (RAI)_questionnaire
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: 7-point Subjective Global Assessment of Nutrition_questionnaire
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: Postoperative Mortality
time frame: 30 and 90 days postoperatively
description: Postoperative mortality
measure: Health Related Quality of Life
time frame: Baseline, day of surgery, 90-days postoperatively
description: Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.
measure: Quality of Surgical Care
time frame: Day of Surgery and 30-days postoperatively
description: AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.
arm group label: Prehabilitation
arm group type: Experimental
description: Standard of care + Prehabilitation
arm group label: Standard of Care
arm group type: No Intervention
description: Standard of Care
intervention type: Behavioral
intervention name: Prehabilitation
description: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.
arm group label: Prehabilitation
criteria: 
gender: All
minimum age: 18 Years
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: 