Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease (NCT05972850) | Clinical Trial Compass
CompletedNot Applicable
Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease
United States28 participantsStarted 2024-03-19
Plain-language summary
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).
Who can participate
Age range
60 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 60 - 80 years
* Lives in a rural area based on established urban-rural definitions (e.g., RUCA codes, RUCC, UIC)
* A qualifying Cardio Vascular Disease (CVD) event or procedure
* 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 if event was within the last 6 months
* 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
* Lives in non-rural area
* No CVD or a qualifying event or procedure
* 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, f…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.