<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/NCT02219815</url>
  </required_header>
  <id_info>
    <org_study_id>PREHAB</org_study_id>
    <nct_id>NCT02219815</nct_id>
  </id_info>
  <brief_title>Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.</brief_title>
  <acronym>PREHAB</acronym>
  <official_title>Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Boniface Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Boniface Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PREHAB study is a clinical trial where frail patients waiting for heart surgery are&#xD;
      randomly chosen to either receive the current standard of care or to participate in an 8-week&#xD;
      exercise/education program at a community-based cardiac rehabilitation facility. Patients can&#xD;
      wait for elective heart surgery for as long as 3-4 months. During this time, individuals are&#xD;
      often fearful of making things worse, causing them to stop being active and further&#xD;
      deteriorate their physical condition. This wait period presents a potential opportunity for&#xD;
      health care providers to engage the patient to take control of their self-managed care prior&#xD;
      to surgery with the intent of improving post-surgical outcomes. Patients randomized to the&#xD;
      PREHAB intervention group will participate in supervised exercise twice per week in a program&#xD;
      designed to improve physical functioning and exercise capacity. The investigators hypothesize&#xD;
      that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will&#xD;
      reduce frailty, improve exercise capacity, improve physical activity behaviour, improve&#xD;
      in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and&#xD;
      improve overall quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PREHAB will be a three centre prospective, randomized, open, blinded endpoint (PROBE)&#xD;
      controlled trial using assessor blinding and intention-to-treat analysis. The study will be&#xD;
      conducted at three academic, tertiary care hospitals (St. Boniface Hospital, Winnipeg, MB,&#xD;
      Montreal Heart Institute. Montreal QC and Queen Elizabeth II Health Sciences Centre, Halifax,&#xD;
      NS) and one non-academic hospital (Saint John Regional Health Centre, Saint John, NB) that&#xD;
      perform cardiac surgery. These sites were chosen based on similar patient populations and&#xD;
      surgical waitlist times. Additionally, each of these sites are partnered with one or more&#xD;
      community-based cardiac rehabilitation (CR) centres, which are certified medical fitness&#xD;
      facilities dedicated to improving the health of the community through health promotion,&#xD;
      disease prevention and rehabilitation services. These facilities offer expert guidance from&#xD;
      certified professionals, innovative health enhancement programs, and provide integrated&#xD;
      medical, rehabilitative and fitness services. The investigators intend to recruit a total of&#xD;
      244 participants to the study (122 per study arm), anticipating a 20% dropout rate to achieve&#xD;
      an eventual sample size of 194 participants.&#xD;
&#xD;
      Patients in the PREHAB group will receive, in addition to standard of care, an eight-week&#xD;
      comprehensive exercise therapy and education program at a community-based CR facility. This&#xD;
      program will target both the physical and psycho-social-cognitive aspects of cardiac disease&#xD;
      and frailty. In brief, participants will be required to complete an intake health status&#xD;
      assessment by the CR team including a physiotherapist, cardiovascular nurse, and dietitian&#xD;
      and complete a symptom-limited graded exercise stress test according to the American College&#xD;
      of Sports Medicine Guidelines for Exercise Testing and Prescription 7th Edition. Patients&#xD;
      will be asked to complete at least two sessions of supervised, structured exercise class plus&#xD;
      have the option to attend one additional exercise class per week for eight-weeks, with&#xD;
      progression to a moderate to high-intensity interval program based on the supervised&#xD;
      assessment of the patient's capabilities. This has been shown to be safe and effective in&#xD;
      unrepaired heart failure and elderly patients. PREHAB participants will also attend four&#xD;
      education sessions on topics such as risk factor reduction, medication use, cardiovascular&#xD;
      physiology, smoking cessation, healthy eating, exercise, and stress management and promotion&#xD;
      of self-managed care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.</measure>
    <time_frame>Post-surgery (approximately 9 weeks after baseline)</time_frame>
    <description>Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline Exercise Capacity</measure>
    <time_frame>baseline assessment - Study entry</time_frame>
    <description>This measure will be assessed using the results of a 6 minute walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative Exercise Capacity</measure>
    <time_frame>Pre-Surgery (approximately 8 weeks after baseline)</time_frame>
    <description>This measure will be assessed using the results of a 6 minute walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Month Exercise Capacity</measure>
    <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
    <description>This measure will be assessed using the results of a 6 minute walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-Year Exercise Capacity</measure>
    <time_frame>1 Year Post-Surgery (approximately 14 months after baseline)</time_frame>
    <description>This measure will be assessed using the results of a 6 minute walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Physical Activity Behaviour</measure>
    <time_frame>baseline assessment - Study entry</time_frame>
    <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative Physical Activity Behaviour</measure>
    <time_frame>Pre-Surgery (approximately 8 weeks after baseline)</time_frame>
    <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Month Physical Activity Behaviour</measure>
    <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
    <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-Year Physical Activity Behaviour</measure>
    <time_frame>1 Year Post-Surgery (approximately 14 months after baseline)</time_frame>
    <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Health-Related Quality of Life</measure>
    <time_frame>baseline assessment - Study entry</time_frame>
    <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperatve Health-Related Quality of Life</measure>
    <time_frame>Pre-Surgery (approximately 8 weeks after baseline)</time_frame>
    <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Month Health-Related Quality of Life</measure>
    <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
    <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-Year Health-Related Quality of Life</measure>
    <time_frame>1 Year Post-Surgery (approximately 14 months after baseline)</time_frame>
    <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Frailty</measure>
    <time_frame>baseline assessment - Study entry</time_frame>
    <description>This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative Frailty</measure>
    <time_frame>Pre-Surgery (approximately 8 weeks after baseline)</time_frame>
    <description>This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Month Frailty</measure>
    <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
    <description>This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-Year Frailty</measure>
    <time_frame>1 Year Post-Surgery (approximately 14 months after baseline)</time_frame>
    <description>This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Anxiety</measure>
    <time_frame>Baseline Assessment - Study entry</time_frame>
    <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative Anxiety</measure>
    <time_frame>Pre-Surgery Assessment (approximately 8 weeks after baseline)</time_frame>
    <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Month Anxiety</measure>
    <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
    <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-Year Anxiety</measure>
    <time_frame>1 Year Post-Surgery (approximately 14 months after baseline)</time_frame>
    <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Depression</measure>
    <time_frame>Baseline Assessment - Study entry</time_frame>
    <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative Depression</measure>
    <time_frame>Pre-surgery Assessment ( 8 weeks after baseline)</time_frame>
    <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Month Depression</measure>
    <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
    <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1 Year Depression</measure>
    <time_frame>1 year Post-Surgery (approximately 14 months after baseline)</time_frame>
    <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Major Adverse Events</measure>
    <time_frame>Post-Surgery (approximately 9 weeks after baseline)</time_frame>
    <description>Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Cardiac Rehabilitation Attendance</measure>
    <time_frame>Post-Surgery (approximately 20 weeks after baseline)</time_frame>
    <description>Will be assessed using administrative data from participating cardiac rehabilitation facilities.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Patients Waiting for Elective Isolated Coronary Artery Bypass Grafting (CABG)</condition>
  <condition>Patients Waiting for Aortic Valve Repair/Replacement for Moderate Aortic Stenosis or Severe Regurgitation</condition>
  <condition>Patients Waiting for Mitral Valve Repair/Replacement for Moderate Stenosis or Severe Regurgitation</condition>
  <condition>Patients Waiting for Combined Procedures. (CAGB and Valve)</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prehab Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prehab Intervention</intervention_name>
    <description>Pre-operative, structured exercise intervention.</description>
    <arm_group_label>Prehab Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 60 years and older, undergoing elective isolated coronary artery bypass&#xD;
             grafting (CABG), aortic valve repair/replacement for moderate aortic stenosis or&#xD;
             severe regurgitation, mitral valve repair/replacement for moderate stenosis or severe&#xD;
             regurgitation or combined CABG/valve procedures&#xD;
&#xD;
          -  Patients with Clinical Frailty Score (CFS) ≥3 (vulnerable) and &lt; 7 (8 = very severely&#xD;
             frail, approaching end-of-life or 9 = terminally ill) at time of acceptance for&#xD;
             cardiac surgery&#xD;
&#xD;
          -  Patients with an estimated ≥ 6 week wait time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have unstable or recent unstable cardiac syndrome as defined by:&#xD;
&#xD;
               1. Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms&#xD;
&#xD;
               2. Critical left main (LM) coronary disease&#xD;
&#xD;
               3. Hospitalization for arrhythmias, congestive heart failure or acute coronary&#xD;
                  syndrome prior to randomization&#xD;
&#xD;
          -  Patients who have severe left ventricular obstructive disease as defined by:&#xD;
&#xD;
               1. Severe aortic or mitral stenosis (aortic or mitral valve area &lt;1.0cm2 or mean&#xD;
                  gradient &gt; 40 mmHg or &gt; 10 mmHg respectively)&#xD;
&#xD;
               2. Dynamic left ventricular (LV) outflow obstruction&#xD;
&#xD;
          -  Patients who have demonstrated exercise induced ventricular arrhythmias or have&#xD;
             experienced a recent hospitalization for arrhythmias&#xD;
&#xD;
          -  Patients who have cognitive deficits that would preclude rehabilitation&#xD;
&#xD;
          -  Patients who have physical limitations that would preclude rehabilitation&#xD;
&#xD;
          -  Patients who are unable to attend the Prehab program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rakesh Arora, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Boniface Hospital/University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Boniface General Hospital</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2H2A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John Regional Hospital - New Brunswick Heart Centre</name>
      <address>
        <city>Saint John</city>
        <state>New Brunswick</state>
        <zip>E2L4L2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laval University</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <results_first_submitted>September 15, 2021</results_first_submitted>
  <results_first_submitted_qc>September 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 13, 2021</results_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Boniface Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Rakesh C. Arora</investigator_full_name>
    <investigator_title>Medical Director, Intensive Care Cardiac Sciences</investigator_title>
  </responsible_party>
  <keyword>Preoperative Care</keyword>
  <keyword>Exercise Therapy</keyword>
  <keyword>Cardiac Surgery</keyword>
  <keyword>Frailty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</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>January 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02219815/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 20, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02219815/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard Care</title>
          <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
        </group>
        <group group_id="P2">
          <title>Prehab Intervention</title>
          <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Post Hospital Discharge Analysis</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3 Month Post Surgery</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>the baseline analysis was based on the completion of the primary outcome of hospital length of stay. Consented participants and participants in the analysis does differ. 8 participants were not involved in the analysis as they did not have surgery or had emergent surgery prior to intervention start.</population>
      <group_list>
        <group group_id="B1">
          <title>Standard Care</title>
          <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
        </group>
        <group group_id="B2">
          <title>Prehab Intervention</title>
          <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</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="42"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="81"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="66"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.3" spread="5.2"/>
                    <measurement group_id="B2" value="71.4" spread="6.4"/>
                    <measurement group_id="B3" value="70.3" spread="5.9"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.</title>
        <description>Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days</description>
        <time_frame>Post-surgery (approximately 9 weeks after baseline)</time_frame>
        <population>patients who successfully had scheduled surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.</title>
          <description>Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days</description>
          <population>patients who successfully had scheduled surgery</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="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.551</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Exercise Capacity</title>
        <description>This measure will be assessed using the results of a 6 minute walk test.</description>
        <time_frame>baseline assessment - Study entry</time_frame>
        <population>analysis of all participants who completed assessment at baseline and who had completed scheduled surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Exercise Capacity</title>
          <description>This measure will be assessed using the results of a 6 minute walk test.</description>
          <population>analysis of all participants who completed assessment at baseline and who had completed scheduled surgery</population>
          <units>meters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="360" lower_limit="300" upper_limit="414"/>
                    <measurement group_id="O2" value="360" lower_limit="300" upper_limit="432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.772</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preoperative Exercise Capacity</title>
        <description>This measure will be assessed using the results of a 6 minute walk test.</description>
        <time_frame>Pre-Surgery (approximately 8 weeks after baseline)</time_frame>
        <population>analysis of all participants who completed assessment at baseline and who had completed scheduled surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Preoperative Exercise Capacity</title>
          <description>This measure will be assessed using the results of a 6 minute walk test.</description>
          <population>analysis of all participants who completed assessment at baseline and who had completed scheduled surgery</population>
          <units>meters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="360" lower_limit="300" upper_limit="398"/>
                    <measurement group_id="O2" value="363" lower_limit="330" upper_limit="450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.231</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>3-Month Exercise Capacity</title>
        <description>This measure will be assessed using the results of a 6 minute walk test.</description>
        <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>3-Month Exercise Capacity</title>
          <description>This measure will be assessed using the results of a 6 minute walk test.</description>
          <units>meters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="400" lower_limit="358" upper_limit="458"/>
                    <measurement group_id="O2" value="405" lower_limit="360" upper_limit="450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.659</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>1-Year Exercise Capacity</title>
        <description>This measure will be assessed using the results of a 6 minute walk test.</description>
        <time_frame>1 Year Post-Surgery (approximately 14 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>1-Year Exercise Capacity</title>
          <description>This measure will be assessed using the results of a 6 minute walk test.</description>
          <units>Meters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="396" lower_limit="360" upper_limit="480"/>
                    <measurement group_id="O2" value="425" lower_limit="366" upper_limit="474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.695</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Physical Activity Behaviour</title>
        <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
        <time_frame>baseline assessment - Study entry</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Physical Activity Behaviour</title>
          <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" lower_limit="17" upper_limit="117"/>
                    <measurement group_id="O2" value="58" lower_limit="35" upper_limit="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.820</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preoperative Physical Activity Behaviour</title>
        <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
        <time_frame>Pre-Surgery (approximately 8 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Preoperative Physical Activity Behaviour</title>
          <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="31" upper_limit="94"/>
                    <measurement group_id="O2" value="61" lower_limit="20" upper_limit="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.991</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>3-Month Physical Activity Behaviour</title>
        <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
        <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>3-Month Physical Activity Behaviour</title>
          <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
          <units>Minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71" lower_limit="25" upper_limit="121"/>
                    <measurement group_id="O2" value="86" lower_limit="70" upper_limit="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.594</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>1-Year Physical Activity Behaviour</title>
        <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
        <time_frame>1 Year Post-Surgery (approximately 14 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>1-Year Physical Activity Behaviour</title>
          <description>This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" lower_limit="24" upper_limit="84"/>
                    <measurement group_id="O2" value="101" lower_limit="55" upper_limit="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.039</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Health-Related Quality of Life</title>
        <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
        <time_frame>baseline assessment - Study entry</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Health-Related Quality of Life</title>
          <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" lower_limit="50" upper_limit="80"/>
                    <measurement group_id="O2" value="60" lower_limit="50" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.351</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preoperatve Health-Related Quality of Life</title>
        <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
        <time_frame>Pre-Surgery (approximately 8 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Preoperatve Health-Related Quality of Life</title>
          <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="45" upper_limit="70"/>
                    <measurement group_id="O2" value="60" lower_limit="50" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.322</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>3-Month Health-Related Quality of Life</title>
        <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
        <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>3-Month Health-Related Quality of Life</title>
          <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="68" upper_limit="85"/>
                    <measurement group_id="O2" value="80" lower_limit="70" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.988</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>1-Year Health-Related Quality of Life</title>
        <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
        <time_frame>1 Year Post-Surgery (approximately 14 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>1-Year Health-Related Quality of Life</title>
          <description>This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="75" upper_limit="85"/>
                    <measurement group_id="O2" value="85" lower_limit="75" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.208</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Frailty</title>
        <description>This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
        <time_frame>baseline assessment - Study entry</time_frame>
        <population>analysis of participants who completed the modified fried assessment at baseline assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Frailty</title>
          <description>This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
          <population>analysis of participants who completed the modified fried assessment at baseline assessment</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="O2" value="2" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.659</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preoperative Frailty</title>
        <description>This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
        <time_frame>Pre-Surgery (approximately 8 weeks after baseline)</time_frame>
        <population>analysis of participants who completed the modified fried assessment at preoperative assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Preoperative Frailty</title>
          <description>This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
          <population>analysis of participants who completed the modified fried assessment at preoperative assessment</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.841</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>3-Month Frailty</title>
        <description>This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
        <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
        <population>analysis on all participants completing the 3-month time point post surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>3-Month Frailty</title>
          <description>This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
          <population>analysis on all participants completing the 3-month time point post surgery</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.646</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>1-Year Frailty</title>
        <description>This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
        <time_frame>1 Year Post-Surgery (approximately 14 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>1-Year Frailty</title>
          <description>This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail</description>
          <units>Score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.730</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Anxiety</title>
        <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
        <time_frame>Baseline Assessment - Study entry</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Anxiety</title>
          <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preoperative Anxiety</title>
        <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
        <time_frame>Pre-Surgery Assessment (approximately 8 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Preoperative Anxiety</title>
          <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="8"/>
                    <measurement group_id="O2" value="3" lower_limit="1" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.681</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>3-Month Anxiety</title>
        <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
        <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>3-Month Anxiety</title>
          <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.876</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>1-Year Anxiety</title>
        <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
        <time_frame>1 Year Post-Surgery (approximately 14 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>1-Year Anxiety</title>
          <description>This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.141</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Depression</title>
        <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
        <time_frame>Baseline Assessment - Study entry</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Depression</title>
          <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.655</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preoperative Depression</title>
        <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
        <time_frame>Pre-surgery Assessment ( 8 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Preoperative Depression</title>
          <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.691</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>3-Month Depression</title>
        <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
        <time_frame>3 Months Post-Surgery (approximately 5 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>3-Month Depression</title>
          <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.709</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>1 Year Depression</title>
        <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
        <time_frame>1 year Post-Surgery (approximately 14 months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>1 Year Depression</title>
          <description>This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.939</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Major Adverse Events</title>
        <description>Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.</description>
        <time_frame>Post-Surgery (approximately 9 weeks after baseline)</time_frame>
        <population>we looked at adverse events (i.e. stroke) for participants who had their scheduled cardiac surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Major Adverse Events</title>
          <description>Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.</description>
          <population>we looked at adverse events (i.e. stroke) for participants who had their scheduled cardiac surgery</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="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Cardiac Rehabilitation Attendance</title>
        <description>Will be assessed using administrative data from participating cardiac rehabilitation facilities.</description>
        <time_frame>Post-Surgery (approximately 20 weeks after baseline)</time_frame>
        <population>Counted the number of PREHAB participants who attended cardiac rehabilitation post cardiac surgery. this data was collected from only 51 participants</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
          </group>
          <group group_id="O2">
            <title>Prehab Intervention</title>
            <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Cardiac Rehabilitation Attendance</title>
          <description>Will be assessed using administrative data from participating cardiac rehabilitation facilities.</description>
          <population>Counted the number of PREHAB participants who attended cardiac rehabilitation post cardiac surgery. this data was collected from only 51 participants</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="26"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>March 2015 to September 2019 - 4 years, 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Standard Care</title>
          <description>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).</description>
        </group>
        <group group_id="E2">
          <title>Prehab Intervention</title>
          <description>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.&#xD;
Prehab Intervention: Pre-operative, structured exercise intervention.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>Major Adverse Events</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <description>Patient suffered a stroke post surgery</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>post operative Delirium</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="42"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <limitations_and_caveats>Recruitment was only 89 participants from an expected sample size of 244 participants. This was a major limitation regarding data analysis.&#xD;
Short cardiac surgery waitlists (i.e. surgery in less than 4 weeks) were impactful to study recruitment and intervention delivery</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Rakesh Arora</name_or_title>
      <organization>St. Boniface Hospital</organization>
      <phone>2042581078</phone>
      <email>rarora@sbgh.mb.ca</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/NCT02219815
org study id: PREHAB
nct id: NCT02219815
lead sponsor: 
has dmc: Yes
The PREHAB study is a clinical trial where frail patients waiting for heart surgery are
      randomly chosen to either receive the current standard of care or to participate in an 8-week
      exercise/education program at a community-based cardiac rehabilitation facility. Patients can
      wait for elective heart surgery for as long as 3-4 months. During this time, individuals are
      often fearful of making things worse, causing them to stop being active and further
      deteriorate their physical condition. This wait period presents a potential opportunity for
      health care providers to engage the patient to take control of their self-managed care prior
      to surgery with the intent of improving post-surgical outcomes. Patients randomized to the
      PREHAB intervention group will participate in supervised exercise twice per week in a program
      designed to improve physical functioning and exercise capacity. The investigators hypothesize
      that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will
      reduce frailty, improve exercise capacity, improve physical activity behaviour, improve
      in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and
      improve overall quality of life.
PREHAB will be a three centre prospective, randomized, open, blinded endpoint (PROBE)
      controlled trial using assessor blinding and intention-to-treat analysis. The study will be
      conducted at three academic, tertiary care hospitals (St. Boniface Hospital, Winnipeg, MB,
      Montreal Heart Institute. Montreal QC and Queen Elizabeth II Health Sciences Centre, Halifax,
      NS) and one non-academic hospital (Saint John Regional Health Centre, Saint John, NB) that
      perform cardiac surgery. These sites were chosen based on similar patient populations and
      surgical waitlist times. Additionally, each of these sites are partnered with one or more
      community-based cardiac rehabilitation (CR) centres, which are certified medical fitness
      facilities dedicated to improving the health of the community through health promotion,
      disease prevention and rehabilitation services. These facilities offer expert guidance from
      certified professionals, innovative health enhancement programs, and provide integrated
      medical, rehabilitative and fitness services. The investigators intend to recruit a total of
      244 participants to the study (122 per study arm), anticipating a 20% dropout rate to achieve
      an eventual sample size of 194 participants.

      Patients in the PREHAB group will receive, in addition to standard of care, an eight-week
      comprehensive exercise therapy and education program at a community-based CR facility. This
      program will target both the physical and psycho-social-cognitive aspects of cardiac disease
      and frailty. In brief, participants will be required to complete an intake health status
      assessment by the CR team including a physiotherapist, cardiovascular nurse, and dietitian
      and complete a symptom-limited graded exercise stress test according to the American College
      of Sports Medicine Guidelines for Exercise Testing and Prescription 7th Edition. Patients
      will be asked to complete at least two sessions of supervised, structured exercise class plus
      have the option to attend one additional exercise class per week for eight-weeks, with
      progression to a moderate to high-intensity interval program based on the supervised
      assessment of the patient's capabilities. This has been shown to be safe and effective in
      unrepaired heart failure and elderly patients. PREHAB participants will also attend four
      education sessions on topics such as risk factor reduction, medication use, cardiovascular
      physiology, smoking cessation, healthy eating, exercise, and stress management and promotion
      of self-managed care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.
time frame: Post-surgery (approximately 9 weeks after baseline)
description: Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days
measure: Baseline Exercise Capacity
time frame: baseline assessment - Study entry
description: This measure will be assessed using the results of a 6 minute walk test.
measure: Preoperative Exercise Capacity
time frame: Pre-Surgery (approximately 8 weeks after baseline)
description: This measure will be assessed using the results of a 6 minute walk test.
measure: 3-Month Exercise Capacity
time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
description: This measure will be assessed using the results of a 6 minute walk test.
measure: 1-Year Exercise Capacity
time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
description: This measure will be assessed using the results of a 6 minute walk test.
measure: Baseline Physical Activity Behaviour
time frame: baseline assessment - Study entry
description: This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
measure: Preoperative Physical Activity Behaviour
time frame: Pre-Surgery (approximately 8 weeks after baseline)
description: This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
measure: 3-Month Physical Activity Behaviour
time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
description: This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
measure: 1-Year Physical Activity Behaviour
time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
description: This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
measure: Baseline Health-Related Quality of Life
time frame: baseline assessment - Study entry
description: This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
measure: Preoperatve Health-Related Quality of Life
time frame: Pre-Surgery (approximately 8 weeks after baseline)
description: This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
measure: 3-Month Health-Related Quality of Life
time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
description: This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
measure: 1-Year Health-Related Quality of Life
time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
description: This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
measure: Baseline Frailty
time frame: baseline assessment - Study entry
description: This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
measure: Preoperative Frailty
time frame: Pre-Surgery (approximately 8 weeks after baseline)
description: This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
measure: 3-Month Frailty
time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
description: This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
measure: 1-Year Frailty
time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
description: This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
measure: Baseline Anxiety
time frame: Baseline Assessment - Study entry
description: This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed
measure: Preoperative Anxiety
time frame: Pre-Surgery Assessment (approximately 8 weeks after baseline)
description: This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed
measure: 3-Month Anxiety
time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
description: This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed
measure: 1-Year Anxiety
time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
description: This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed
measure: Baseline Depression
time frame: Baseline Assessment - Study entry
description: This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression
measure: Preoperative Depression
time frame: Pre-surgery Assessment ( 8 weeks after baseline)
description: This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression
measure: 3-Month Depression
time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
description: This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression
measure: 1 Year Depression
time frame: 1 year Post-Surgery (approximately 14 months after baseline)
description: This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression
measure: Postoperative Major Adverse Events
time frame: Post-Surgery (approximately 9 weeks after baseline)
description: Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.
measure: Postoperative Cardiac Rehabilitation Attendance
time frame: Post-Surgery (approximately 20 weeks after baseline)
description: Will be assessed using administrative data from participating cardiac rehabilitation facilities.
arm group label: Standard Care
arm group type: No Intervention
description: Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).
arm group label: Prehab Intervention
arm group type: Experimental
description: Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.
intervention type: Behavioral
intervention name: Prehab Intervention
description: Pre-operative, structured exercise intervention.
arm group label: Prehab Intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Rakesh Arora, MD
role: Principal Investigator
affiliation: St. Boniface Hospital/University of Manitoba
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Boniface Hospital
investigator full name: Dr. Rakesh C. Arora
investigator title: Medical Director, Intensive Care Cardiac Sciences
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Recruitment was only 89 participants from an expected sample size of 244 participants. This was a major limitation regarding data analysis.
Short cardiac surgery waitlists (i.e. surgery in less than 4 weeks) were impactful to study recruitment and intervention delivery
point of contact: 