Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease

Study Overview
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Brief Summary
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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).

Official Title
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Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Vivo Heart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 - 80 years Rural-Urban Commuting Area code (RUCA) code 4-10 A qualifying Cardio Vascular Disease (CVD) event or procedure within the past 12 months Cognitively unimpaired Telephone Interview for Cognitive Status (TICS-m ≥32) No major depressive symptoms Patient Health Questionnaire (PHQ-8 <10) Ambulatory and community-dwelling Less than 150 min per week of moderate-to-intensive aerobic or resistance exercise in the past month Medically cleared for exercise Approved for participation by cardiologist Access to a tablet or computer and internet/Wi-Fi in defined exercise space Able to provide own transportation to study visits Not participating in a clinical trial Willing to provide informed consent Exclusion Criteria: <60 years or >80 years RUCA code 1-3 No CVD or a qualifying event or procedure >12 months ago Dementia or severe cognitive impairment (TICS-m <32) Clinical depression (PHQ-8 ≥10) Non-ambulatory, institutionalized, or requires walker Regular aerobic or resistance exercise (including current participation in a cardiac rehab program) Not medically cleared for exercise Advanced kidney disease requiring dialysis or dialysis anticipated within 6 months Insulin-dependent diabetes Use of any supplemental oxygen for COPD Significant impairment from a prior stroke Progressive neurologic disease (Parkinson's, ALS, multiple sclerosis, Alzheimer's disease, dementia) Severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that prevents walking independently Cancer (not including non-melanoma skin cancers) requiring treatment with the past year Excessive alcohol consumption (>7/week alcoholic beverages for women and >14/week for men) in the past month Joint replacement or other orthopedic surgery in past 12 months or planned in next 6 months No computer, tablet or internet access No access to transportation for travel to study visits Current participation in a clinical trial Inability or unwillingness to comply with the study requirements

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vivo Heart<br>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). | Behavioral: Vivo Heart<br>* 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.<br>* Other names: Vivo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion Rate | Completion rate which will be determined by the percentage of enrolled participants who complete the study with ≥80% compliance. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | Recruitment rate will be determined by the total number of enrolled participants divided by the number of months recruitment occurred. | Year 1 | 
| Recruitment Yield | Recruitment yield will be determined based on the number of participants randomized relative to the total number of volunteers screened | Year 1 | 
| Compliance Rate | 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. | Week 12 | 
| Retention Rate | Retention will be determined by the percentage of enrolled participations who complete follow-up testing. | Week 12 | 
| Satisfaction Survey Scores | Acceptability will be assessed at the end of the study using a program satisfaction survey. | Week 12 | 
| Continuation Rate | Uptake will be determined by the number of participants who continue in the Vivo program after the study is over. | Year 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home-based cardiac rehabilitation, mobile health technologies, strength and physical function, synchronous virtual exercise program