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

27 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Vivo Heart in the Virtual Exercise Program for Cardiovascular Disease?

Research shows that virtual reality-based exercise programs can improve both physical and mental health outcomes for people with heart disease. These programs have been found to enhance quality of life, increase physical activity, and reduce stress and anxiety, which are important for heart health. ^{1 2 3 4 5}

Is the Virtual Exercise Program for Cardiovascular Disease safe for humans?

Research shows that exercise programs, including high-intensity interval training (HIIT), have a low rate of major adverse events in patients with cardiovascular disease when conducted in supervised settings. Most adverse events are minor, such as muscle soreness, and serious events are rare. ^{6 7 8 9 10}

What makes the Vivo Heart treatment unique for cardiovascular disease?

The Vivo Heart treatment is unique because it involves a virtual exercise program that simulates the physiological response to aerobic exercise, which can help improve exercise performance in patients with cardiovascular disease by addressing specific impairments in heart function and oxygen delivery. ^{11 12 13 14 15}

What is the purpose of this trial?

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).

Research Team

Tina E Brinkley, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

No major depressive symptoms Patient Health Questionnaire (PHQ-8 <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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Virtual reality exercise on a home-based phase III cardiac rehabilitation program, effect on executive function, quality of life and depression, anxiety and stress: a randomized controlled trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions for cardiac rehabilitation: a literature review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality interventions on physiological and psychological outcomes of adults with cardiovascular disease: A systematic review and meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Acute Hemodynamic Effects of Virtual Reality-Based Therapy in Patients of Cardiovascular Rehabilitation: A Cluster Randomized Crossover Trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of exercise modalities on central hemodynamics, arterial stiffness and cardiac function in cardiovascular disease: Systematic review and meta-analysis of randomized controlled trials. [2019]

6. England 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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10. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A Model of the Cardiorespiratory Response to Aerobic Exercise in Healthy and Heart Failure Conditions. [2020]

12. China pubmed.ncbi.nlm.nih.gov

Exercise physiology in left ventricular assist device patients: insights from hemodynamic simulations. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Real-Time ECG Simulation for Hybrid Mock Circulatory Loops. [2018]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Initial clinical validation of a hybrid in silico-in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Improving In vitro Evaluation Capabilities of Cardiac Assist Devices through a Validated Exercise Simulation. [2020]