xml: <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/NCT05972850</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00094007</org_study_id>
      <secondary_id>P30AG021332</secondary_id>
      <nct_id>NCT05972850</nct_id>
    </id_info>
    <brief_title>Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease</brief_title>
    <official_title>Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Wake Forest University Health Sciences</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This pilot study will assess the feasibility and generate preliminary efficacy data of a&#xD;
        novel, synchronous, home-based exercise training program for rural older adults with&#xD;
        cardiovascular disease (CVD) using Vivo, an online, live, small group fitness program&#xD;
        developed for older adults. It uses individually tailored dual-tasked (i.e., cognitive-motor)&#xD;
        exercises to improve strength, endurance, balance, and cognition and incorporates social&#xD;
        engagement. Certified trainers deliver instruction and coaching through an interactive&#xD;
        session (45 min, 2-3 times/week) delivered over 12 weeks. Vivo Heart adapts this unique&#xD;
        program to meet the cardiac rehabilitation needs of older adults with CVD. The specific aims&#xD;
        are to evaluate the feasibility, acceptability, and uptake of Vivo Heart (Aim 1) and obtain&#xD;
        pre- and post-intervention measures of exercise capacity, strength, lower-extremity physical&#xD;
        function, cognition, quality of life, stress, fatigability, physical activity, and aging&#xD;
        biomarkers (Aim 2).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>40 rural-living older adults (60-80 years; Rural-Urban Commuting Area code 4-10) with a history of cardiovascular disease (prior myocardial infarction, angina, or coronary procedure) who are medically cleared for exercise by their cardiologist.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Completion Rate</measure>
      <time_frame>Week 12</time_frame>
      <description>Completion rate which will be determined by the percentage of enrolled participants who complete the study with ≥80% compliance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recruitment Rate</measure>
      <time_frame>Year 1</time_frame>
      <description>Recruitment rate will be determined by the total number of enrolled participants divided by the number of months recruitment occurred.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recruitment Yield</measure>
      <time_frame>Year 1</time_frame>
      <description>Recruitment yield will be determined based on the number of participants randomized relative to the total number of volunteers screened</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compliance Rate</measure>
      <time_frame>Week 12</time_frame>
      <description>Compliance will be determined based on adherence to the prescribed intervention. Compliance metrics will include attendance at the exercise sessions, health education classes, and dietary counseling sessions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Retention Rate</measure>
      <time_frame>Week 12</time_frame>
      <description>Retention will be determined by the percentage of enrolled participations who complete follow-up testing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction Survey Scores</measure>
      <time_frame>Week 12</time_frame>
      <description>Acceptability will be assessed at the end of the study using a program satisfaction survey.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Continuation Rate</measure>
      <time_frame>Year 1</time_frame>
      <description>Uptake will be determined by the number of participants who continue in the Vivo program after the study is over.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>VO2 peak</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in VO2 peak</description>
    </other_outcome>
    <other_outcome>
      <measure>Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in overall cognition (0-30)</description>
    </other_outcome>
    <other_outcome>
      <measure>Digit Symbol Coding (DSC)</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in processing speed, working memory, visuospatial processing, and attention (secs)</description>
    </other_outcome>
    <other_outcome>
      <measure>Timed Up and Go (TUG)</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in time to complete (secs)</description>
    </other_outcome>
    <other_outcome>
      <measure>Expanded Short Physical Performance Battery (eSPPB)</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in score (0-4)</description>
    </other_outcome>
    <other_outcome>
      <measure>The Four Square Step Test (FSST)</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in time to complete (secs)</description>
    </other_outcome>
    <other_outcome>
      <measure>4-step Stair Climb Test (4SCT)</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in time to complete (secs)</description>
    </other_outcome>
    <other_outcome>
      <measure>Grip Strength</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in grip strength (kg)</description>
    </other_outcome>
    <other_outcome>
      <measure>Perceived Stress Scale (PSS)</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in score</description>
    </other_outcome>
    <other_outcome>
      <measure>Short Form-36 Health Survey (SF-36)</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in score</description>
    </other_outcome>
    <other_outcome>
      <measure>UCLA Loneliness Scale</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in score</description>
    </other_outcome>
    <other_outcome>
      <measure>Life Space</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in score</description>
    </other_outcome>
    <other_outcome>
      <measure>Pittsburgh Fatigability Scale (PFS)</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in score</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in systolic and diastolic blood pressure (mmHg)</description>
    </other_outcome>
    <other_outcome>
      <measure>Heart rate</measure>
      <time_frame>Week 12</time_frame>
      <description>Change in resting heart rate (bpm)</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cardiovascular Disease</condition>
    <arm_group>
      <arm_group_label>Vivo Heart</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This virtual intervention will include weekly group exercise sessions with a Vivo trainer (2 times/week), weekly health education classes with a registered dietitian (RD) (1 time/week), and two individual meetings with the RD over the course of 12 weeks. Participants will also be asked to complete a weekly aerobic exercise session on their own (1 time/week).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Vivo Heart</intervention_name>
      <description>Vivo is an online, live, small group fitness program developed for older adults that uses individually tailored dual-tasked (i.e., cognitive-motor) exercises to improve strength, endurance, balance, and cognition and incorporates social engagement. Certified trainers deliver instruction and coaching through an interactive session for 45 min, 2-3 times/week.</description>
      <arm_group_label>Vivo Heart</arm_group_label>
      <other_name>Vivo</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  60 - 80 years&#xD;
  &#xD;
            -  Rural-Urban Commuting Area code (RUCA) code 4-10&#xD;
  &#xD;
            -  A qualifying Cardio Vascular Disease (CVD) event or procedure within the past 12&#xD;
               months&#xD;
  &#xD;
            -  Cognitively unimpaired Telephone Interview for Cognitive Status (TICS-m ≥32)&#xD;
  &#xD;
            -  No major depressive symptoms Patient Health Questionnaire (PHQ-8 &lt;10)&#xD;
  &#xD;
            -  Ambulatory and community-dwelling&#xD;
  &#xD;
            -  Less than 150 min per week of moderate-to-intensive aerobic or resistance exercise in&#xD;
               the past month&#xD;
  &#xD;
            -  Medically cleared for exercise&#xD;
  &#xD;
            -  Approved for participation by cardiologist&#xD;
  &#xD;
            -  Access to a tablet or computer and internet/Wi-Fi in defined exercise space&#xD;
  &#xD;
            -  Able to provide own transportation to study visits&#xD;
  &#xD;
            -  Not participating in a clinical trial&#xD;
  &#xD;
            -  Willing to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;60 years or &gt;80 years&#xD;
  &#xD;
            -  RUCA code 1-3&#xD;
  &#xD;
            -  No CVD or a qualifying event or procedure &gt;12 months ago&#xD;
  &#xD;
            -  Dementia or severe cognitive impairment (TICS-m &lt;32)&#xD;
  &#xD;
            -  Clinical depression (PHQ-8 ≥10)&#xD;
  &#xD;
            -  Non-ambulatory, institutionalized, or requires walker&#xD;
  &#xD;
            -  Regular aerobic or resistance exercise (including current participation in a cardiac&#xD;
               rehab program)&#xD;
  &#xD;
            -  Not medically cleared for exercise&#xD;
  &#xD;
            -  Advanced kidney disease requiring dialysis or dialysis anticipated within 6 months&#xD;
  &#xD;
            -  Insulin-dependent diabetes&#xD;
  &#xD;
            -  Use of any supplemental oxygen for COPD&#xD;
  &#xD;
            -  Significant impairment from a prior stroke&#xD;
  &#xD;
            -  Progressive neurologic disease (Parkinson's, ALS, multiple sclerosis, Alzheimer's&#xD;
               disease, dementia)&#xD;
  &#xD;
            -  Severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that&#xD;
               prevents walking independently&#xD;
  &#xD;
            -  Cancer (not including non-melanoma skin cancers) requiring treatment with the past&#xD;
               year&#xD;
  &#xD;
            -  Excessive alcohol consumption (&gt;7/week alcoholic beverages for women and &gt;14/week for&#xD;
               men) in the past month&#xD;
  &#xD;
            -  Joint replacement or other orthopedic surgery in past 12 months or planned in next 6&#xD;
               months&#xD;
  &#xD;
            -  No computer, tablet or internet access&#xD;
  &#xD;
            -  No access to transportation for travel to study visits&#xD;
  &#xD;
            -  Current participation in a clinical trial&#xD;
  &#xD;
            -  Inability or unwillingness to comply with the study requirements&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tina E Brinkley, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kimberly Kennedy, MS, CCRC</last_name>
      <phone>336.713.8567</phone>
      <email>kkennedy@wakehealth.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Wake Forest University Health Sciences</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27157</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kimberly Kennedy, MS, CCRC</last_name>
        <phone>336-713-8567</phone>
        <email>kkennedy@wakehealth.edu</email>
      </contact>
      <investigator>
        <last_name>Tina E Brinkley, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>home-based cardiac rehabilitation</keyword>
    <keyword>mobile health technologies</keyword>
    <keyword>strength and physical function</keyword>
    <keyword>synchronous virtual exercise program</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972850
  org study id: IRB00094007
  secondary id: P30AG021332
  nct id: NCT05972850
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This pilot study will assess the feasibility and generate preliminary efficacy data of a
        novel, synchronous, home-based exercise training program for rural older adults with
        cardiovascular disease (CVD) using Vivo, an online, live, small group fitness program
        developed for older adults. It uses individually tailored dual-tasked (i.e., cognitive-motor)
        exercises to improve strength, endurance, balance, and cognition and incorporates social
        engagement. Certified trainers deliver instruction and coaching through an interactive
        session (45 min, 2-3 times/week) delivered over 12 weeks. Vivo Heart adapts this unique
        program to meet the cardiac rehabilitation needs of older adults with CVD. The specific aims
        are to evaluate the feasibility, acceptability, and uptake of Vivo Heart (Aim 1) and obtain
        pre- and post-intervention measures of exercise capacity, strength, lower-extremity physical
        function, cognition, quality of life, stress, fatigability, physical activity, and aging
        biomarkers (Aim 2).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: 40 rural-living older adults (60-80 years; Rural-Urban Commuting Area code 4-10) with a history of cardiovascular disease (prior myocardial infarction, angina, or coronary procedure) who are medically cleared for exercise by their cardiologist.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Completion Rate
  time frame: Week 12
  description: Completion rate which will be determined by the percentage of enrolled participants who complete the study with ≥80% compliance.
  measure: Recruitment Rate
  time frame: Year 1
  description: Recruitment rate will be determined by the total number of enrolled participants divided by the number of months recruitment occurred.
  measure: Recruitment Yield
  time frame: Year 1
  description: Recruitment yield will be determined based on the number of participants randomized relative to the total number of volunteers screened
  measure: Compliance Rate
  time frame: Week 12
  description: Compliance will be determined based on adherence to the prescribed intervention. Compliance metrics will include attendance at the exercise sessions, health education classes, and dietary counseling sessions.
  measure: Retention Rate
  time frame: Week 12
  description: Retention will be determined by the percentage of enrolled participations who complete follow-up testing.
  measure: Satisfaction Survey Scores
  time frame: Week 12
  description: Acceptability will be assessed at the end of the study using a program satisfaction survey.
  measure: Continuation Rate
  time frame: Year 1
  description: Uptake will be determined by the number of participants who continue in the Vivo program after the study is over.
  measure: VO2 peak
  time frame: Week 12
  description: Change in VO2 peak
  measure: Montreal Cognitive Assessment (MoCA)
  time frame: Week 12
  description: Change in overall cognition (0-30)
  measure: Digit Symbol Coding (DSC)
  time frame: Week 12
  description: Change in processing speed, working memory, visuospatial processing, and attention (secs)
  measure: Timed Up and Go (TUG)
  time frame: Week 12
  description: Change in time to complete (secs)
  measure: Expanded Short Physical Performance Battery (eSPPB)
  time frame: Week 12
  description: Change in score (0-4)
  measure: The Four Square Step Test (FSST)
  time frame: Week 12
  description: Change in time to complete (secs)
  measure: 4-step Stair Climb Test (4SCT)
  time frame: Week 12
  description: Change in time to complete (secs)
  measure: Grip Strength
  time frame: Week 12
  description: Change in grip strength (kg)
  measure: Perceived Stress Scale (PSS)
  time frame: Week 12
  description: Change in score
  measure: Short Form-36 Health Survey (SF-36)
  time frame: Week 12
  description: Change in score
  measure: UCLA Loneliness Scale
  time frame: Week 12
  description: Change in score
  measure: Life Space
  time frame: Week 12
  description: Change in score
  measure: Pittsburgh Fatigability Scale (PFS)
  time frame: Week 12
  description: Change in score
  measure: Blood pressure
  time frame: Week 12
  description: Change in systolic and diastolic blood pressure (mmHg)
  measure: Heart rate
  time frame: Week 12
  description: Change in resting heart rate (bpm)
  arm group label: Vivo Heart
  arm group type: Experimental
  description: This virtual intervention will include weekly group exercise sessions with a Vivo trainer (2 times/week), weekly health education classes with a registered dietitian (RD) (1 time/week), and two individual meetings with the RD over the course of 12 weeks. Participants will also be asked to complete a weekly aerobic exercise session on their own (1 time/week).
  intervention type: Behavioral
  intervention name: Vivo Heart
  description: Vivo is an online, live, small group fitness program developed for older adults that uses individually tailored dual-tasked (i.e., cognitive-motor) exercises to improve strength, endurance, balance, and cognition and incorporates social engagement. Certified trainers deliver instruction and coaching through an interactive session for 45 min, 2-3 times/week.
  arm group label: Vivo Heart
  other name: Vivo
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Tina E Brinkley, PhD
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Kimberly Kennedy, MS, CCRC
  phone: 336.713.8567
  email: kkennedy@wakehealth.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  sharing ipd: No