Virtual Exercise Program for Cardiovascular Disease

Overseen By Tina E Brinkley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Insulin, Oxygen

Disqualifiers: Dementia, Depression, Stroke, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online exercise program called Vivo Heart, designed for older adults with heart issues, particularly those in rural areas. The program emphasizes exercises that enhance strength, balance, and brain health, and it includes social interaction. Participants will join live group sessions with trainers twice a week for 12 weeks. This trial suits individuals aged 60-80 who have experienced a heart-related event, live in rural areas, and are not currently engaged in regular exercise or another trial. As an unphased trial, it offers a unique opportunity to improve health and connect with others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual exercise program is safe for older adults with cardiovascular disease?

Research has shown that regular exercise is generally safe and beneficial for heart health. This includes programs like Vivo Heart, a virtual exercise program designed for older adults with heart disease. Studies have found that exercise routines, especially those tailored to individual needs, can enhance heart health, strength, and overall quality of life.

Vivo Heart stands out by combining physical exercise with brain activities, which helps improve both physical and mental health. So far, programs like Vivo Heart have not reported major safety concerns. When done correctly and with guidance, exercise is usually well-tolerated by participants.

The online nature of Vivo Heart also enhances safety. Participants can join from home, avoiding travel-related issues. Additionally, the involvement of certified trainers and dietitians ensures that exercises are performed safely and effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vivo Heart because it offers a fresh approach to managing cardiovascular disease through virtual means. Unlike traditional treatments that often focus on medication and in-person sessions, Vivo Heart combines online group exercise with personalized nutrition classes and individual consultations with a dietitian. This method allows for greater accessibility and flexibility, empowering participants to engage in their health journey from home. By integrating technology with personalized health education, Vivo Heart aims to make cardiovascular care more interactive and adaptable to modern lifestyles.

What evidence suggests that this virtual exercise program is effective for cardiovascular disease?

Research shows that exercise programs can improve heart health and physical abilities in older adults with heart disease. Studies have found that regular physical activity enhances heart health by building strength and endurance. Vivo Heart, the treatment tested in this trial, is an online exercise program focusing on these benefits through strength training and interactive sessions. Early results suggest these programs also help with balance, thinking skills, and overall quality of life. Thus, Vivo Heart could effectively boost both physical and mental well-being for older adults with heart conditions. ^{2 3 6 7 8}

Who Is on the Research Team?

Tina E Brinkley, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

The Vivo Heart trial is for rural adults aged 60-80 with recent cardiovascular events, who are medically cleared for exercise and not doing much physical activity currently. They need internet access and a device to participate in virtual sessions but can't join if they use oxygen for COPD, have clinical depression, or other major health issues.

Inclusion Criteria

Cognitively unimpaired Telephone Interview for Cognitive Status (TICS-m ≥32)

Medically cleared for exercise

Rural-Urban Commuting Area code (RUCA) code 4-10

Exclusion Criteria

I cannot walk on my own and may need help or a device to move around.

I need dialysis now or will need it in the next 6 months due to advanced kidney disease.

I have lasting effects from a previous stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a home-based virtual exercise program with Vivo trainers, including group exercise sessions, health education classes, and individual meetings with a dietitian over 12 weeks.

12 weeks

2-3 virtual sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of exercise capacity, strength, cognition, and quality of life.

4 weeks

Continuation

Participants may continue in the Vivo program after the study is over, assessing long-term uptake and continuation rates.

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Vivo Heart

Trial Overview Vivo Heart tests a home-based exercise program tailored for older adults with heart disease. It involves live online group fitness that focuses on strength, endurance, balance, cognition and social interaction through certified trainers over a 12-week period.

How Is the Trial Designed?

Group I: Vivo Heart Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

Mobile technologies, including wearable activity monitors and virtual rehabilitation solutions, have the potential to enhance adherence to cardiac rehabilitation, which is crucial for improving quality of life and reducing hospitalizations.

The review of 113 studies showed mixed results regarding the efficacy of virtual cardiac rehabilitation compared to traditional methods, but highlighted the importance of user adherence and long-term engagement as key benefits of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions for cardiac rehabilitation: a literature review. Lee, KCS., Breznen, B., Ukhova, A., et al.[2023]

The EXPERT tool was developed to assist clinicians in prescribing exercise for patients with various cardiovascular diseases and risk factors, providing tailored recommendations based on specific conditions and individual patient factors.

This digital system offers exercise training recommendations and safety advice for 10 cardiovascular diseases and several chronic conditions, potentially improving the implementation of exercise rehabilitation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European Association of Preventive Cardiology Exercise Prescription in Everyday Practice and Rehabilitative Training (EXPERT) tool: A digital training and decision support system for optimized exercise prescription in cardiovascular disease. Concept, definitions and construction methodology. Hansen, D., Dendale, P., Coninx, K., et al.[2018]

Citations

1. ctv.veeva.com ctv.veeva.com/study/vivo-heart-home-based-virtual-exercise-program-for-older-adults-with-cardiovascular-disease

Vivo Heart: Home-Based Virtual Exercise Program for Older ... This pilot study will assess the feasibility and generate preliminary efficacy data of a novel, synchronous, home-based exercise training program for rural ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10339344/

Personalized remotely guided preventive exercise therapy for ... Outcomes will be assessed at baseline, 4 months, one and two years. The primary outcome is the peak oxygen uptake (pVO2) at 1-year. Secondary ...

3. home.agetechcollaborative.org home.agetechcollaborative.org/blogs/mark-ogilbee/2023/03/15/vivo-improving-health-outcomes-through-strength-tr

Vivo: Improving Health Outcomes through Strength Training Vivo is an online, live and interactive fitness program for older adults with a focus on increasing strength and function.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10880299/

Development and application of a home-based exercise ... This study aimed to develop a home-based CR program and assess the feasibility of the program over a 6-week period in patients with left ventricular ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.125.325526

Epidemiology and Cardiovascular Benefits of Physical ... In this review, we focus on the beneficial effects of routine physical activity (PA) on the cardiovascular system, the different ways we can achieve and ...

6. withpower.com withpower.com/trial/phase-cardiovascular-diseases-8-2023-16749

Virtual Exercise Program for Cardiovascular Disease This digital system offers exercise training recommendations and safety advice for 10 cardiovascular diseases and several chronic conditions, potentially ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9437103/

Exercise training maintains cardiovascular health: signaling ... Data from a myriad of clinical and basic research studies have demonstrated the beneficial effects of exercise training on cardiovascular health ...

8. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1194693/full

Personalized remotely guided preventive exercise therapy ... Outcomes will be assessed at baseline, 4 months, one and two years. The primary outcome is the peak oxygen uptake (pVO2) at 1-year. Secondary ...