Supervised Exercise for Single Ventricle Heart Condition

Overseen By Seda Tierney

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe heart failure, Acute illness, others

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

Compensation: Varies

Number of Visits: 3

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a supervised exercise program can benefit children with a single-ventricle heart condition, specifically those who have undergone the Fontan procedure. The goal is to determine if regular, guided exercise can improve heart and physical health, boost muscle strength, and support better blood vessel function. Participants will either begin the Live-Video-Supervised Exercise Intervention immediately or after a period of usual care. This trial suits children and teens aged 8 to 19 who have had the Fontan procedure and can safely exercise.

As an unphased trial, this study provides a unique opportunity for participants to contribute to valuable research that could enhance care for future patients.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise intervention is safe for children with single ventricle heart conditions?

Research has shown that exercising with live video supervision is generally safe for people with heart conditions, including children and teens with congenital heart issues. Studies have found that this type of exercise can enhance heart and physical fitness, muscle strength, and overall health without major safety concerns. Specifically, for children with single ventricle heart conditions, interactive telehealth programs like this exercise plan have been linked to fewer problems and reduced need for emergency care. Overall, live-video-supervised exercise is well-tolerated and considered safe for children with similar heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the live-video-supervised exercise intervention for single ventricle heart conditions because it introduces a novel delivery method that allows patients to engage in supervised exercise sessions remotely. This approach contrasts with the standard of care, which typically involves physical therapy or unsupervised exercise. The live video format provides consistent guidance and monitoring, potentially increasing adherence to exercise routines. Additionally, this intervention aims to empower patients by enabling them to exercise independently with personalized plans, using heart rate monitors for feedback. Overall, this method could lead to improved heart health in a more accessible and flexible way.

What evidence suggests that this live-video-supervised exercise intervention is effective for single ventricle heart condition?

Research has shown that exercise programs can improve health in children with single ventricle heart conditions. In this trial, participants will join one of two groups. One group will start with a Live-Video-Supervised Exercise Intervention, while the other will receive usual care before beginning the exercise intervention. Studies have found that live video-supervised exercise is safe and can enhance exercise ability and muscle growth in young patients with congenital heart disease. These programs have also reduced complications and emergency visits for infants with similar heart issues. Additionally, they have improved muscle strength and overall heart health. This evidence suggests that structured exercise could benefit children with the Fontan circulation, potentially reducing long-term risks. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children and teenagers aged 8-19 with a single ventricle heart condition who've had Fontan palliation. They must be able to fast overnight, speak English, have cardiac clearance to exercise, and if under 14, an adult must be present during exercise sessions.

Inclusion Criteria

I am under 14 and will have an adult with me during exercise sessions.

I have undergone the Fontan procedure for heart disease.

I am between 8 and 19 years old.

Exclusion Criteria

I have not been seriously ill in the last 3 months.

I have severe heart failure.

You have a pacemaker implanted.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Intervention

Participants in the exercise intervention arm will participate in live-video-supervised exercise sessions 3 times a week for 3 months

3 months

Live-video sessions 3 times a week

Maintenance

Participants will continue with a maintenance regimen of live-video-supervised exercise sessions once a week and self-directed exercise twice a week for 6 months

6 months

Live-video sessions once a week, self-directed exercise twice a week

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Live-Video-Supervised Exercise Intervention
• Usual Care then Live-Video Supervised Exercise Intervention

Trial Overview The study tests whether a live-video-supervised exercise program can improve heart and physical capacity, muscle mass and strength, as well as endothelial function in pediatric patients with the Fontan palliation compared to usual care followed by the intervention.

How Is the Trial Designed?

Group I: Live-Video-Supervised Exercise Control Arm Experimental Treatment 1 Intervention

Patients randomized to usual care at baseline will receive usual care for 9 months and will then start the 3-month exercise intervention of live-video-supervised exercise sessions x3/week for 3 months.

Group II: Live Video-Supervised Exercise Intervention Arm Experimental Treatment 1 Intervention

Patients randomized to exercise intervention at baseline will participate in live-video-supervised exercise sessions x3/week for 3 months, and then will follow a maintenance regimen for 6 months. During maintenance, patients will continue live-video-supervised exercise sessions, only x1/week, and will be instructed to exercise on their own x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

The Methodist Hospital Research Institute

Collaborator

Trials

299

Recruited

82,500+

Published Research Related to This Trial

Home-based exercise training is a safe and effective alternative to supervised training for patients with congenital heart disease (CHD), with improvements in exercise capacity and walking distance observed in several studies involving both children and adults.

Despite the benefits, high dropout rates (15%) and a lack of reported compliance in many studies (58%) highlight the challenges in maintaining participation in home-based exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current state of home-based exercise interventions in patients with congenital heart disease: a systematic review. Meyer, M., Brudy, L., García-Cuenllas, L., et al.[2020]

In a study of 28 heart failure patients, those who participated in supervised combined physical training showed significant improvements in functional capacity and quality of life compared to those who followed an unsupervised exercise regimen over 12 weeks.

The trained group also experienced enhancements in left ventricular systolic function, indicating that structured exercise programs can be more beneficial for heart failure patients than standard physician-prescribed exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Supervised Twelve-Week Combined Physical Training Program in Heart Failure Patients: A Randomized Trial. Fabri, T., Catai, AM., Ribeiro, FHO., et al.[2022]

A randomized controlled trial involving 169 heart failure patients found that a home-based exercise program combined with specialist nurse care did not significantly improve overall quality of life or heart failure symptoms compared to nurse care alone.

However, the exercise group did show some benefits, including improved generic quality of life and reduced anxiety and depression scores at 6 and 12 months, suggesting that while home-based exercise may not be broadly effective, it can have specific positive effects on mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of the addition of home-based exercise to specialist heart failure nurse care: the Birmingham Rehabilitation Uptake Maximisation study for patients with Congestive Heart Failure (BRUM-CHF) study. Jolly, K., Taylor, RS., Lip, GY., et al.[2021]

In a study of 12 patients with chronic heart failure, a 4-6 month exercise training program significantly improved peak oxygen consumption by 23%, indicating enhanced exercise capacity.

The training led to important peripheral adaptations, such as increased leg blood flow and arteriovenous oxygen difference, which contributed to better exercise performance, despite no significant changes in heart function measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in patients with severe left ventricular dysfunction. Hemodynamic and metabolic effects. Sullivan, MJ., Higginbotham, MB., Cobb, FR.[2022]

A 12- to 16-week live video-supervised exercise and diet intervention for pediatric heart transplant recipients showed excellent adherence, with 89.6% attendance for exercise sessions and 88.4% for nutrition sessions.

Significant health improvements were observed, including a reduction in body mass index percentile, enhanced endothelial function, and increased maximum oxygen consumption, indicating that this intervention can positively impact cardiovascular and functional health in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Hearts via Live Videoconferencing: An Exercise and Diet Intervention in Pediatric Heart Transplant Recipients. Chen, AC., Ramirez, FD., Rosenthal, DN., et al.[2021]

The FORCE tool, which classifies patients with congenital heart disease (CHD) based on hemodynamic factors, was successfully implemented in 98% of cases, demonstrating its feasibility for risk stratification in exercise prescriptions.

No adverse events were reported during nearly 1000 exercise training sessions, indicating that the FORCE tool is safe for guiding cardiac rehabilitation in patients under 22 years old.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FORCE Risk Stratification Tool for Pediatric Cardiac Rehabilitation and Fitness Programs. Gauthier, N., Reynolds, L., Curran, T., et al.[2023]

The updated recommendations for competitive sports participation in adults with congenital heart disease (CHD) focus on assessing individual health parameters like haemodynamics and electrophysiology, rather than just anatomical lesions, allowing for more personalized exercise advice.

This new approach aims to improve safety and risk stratification for athletes with CHD, acknowledging the benefits of exercise while addressing the low risk of exercise-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for participation in competitive sport in adolescent and adult athletes with Congenital Heart Disease (CHD): position statement of the Sports Cardiology & Exercise Section of the European Association of Preventive Cardiology (EAPC), the European Society of Cardiology (ESC) Working Group on Adult Congenital Heart Disease and the Sports Cardiology, Physical Activity and Prevention Working Group of the Association for European Paediatric and Congenital Cardiology (AEPC). Budts, W., Pieles, GE., Roos-Hesselink, JW., et al.[2021]

Youth with congenital heart disease (CHD) often have reduced exercise capacity and lower quality of life, highlighting the need for effective exercise interventions, particularly home-based programs that can be monitored via telemedicine.

A new 12-week randomized crossover trial is being conducted to evaluate the effectiveness of a home-based high-intensity interval training program using a video game-linked cycle ergometer, which may provide better cardiorespiratory benefits compared to traditional moderate-intensity exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. Spence, C., Khoo, N., Mackie, A., et al.[2023]

Children and adolescents with congenital and acquired heart disease (CHD) often do not get enough physical activity, but exercise interventions can significantly improve their health outcomes.

The cardiac exercise therapeutics (CET) model offers a structured approach to promote physical activity through various levels of intervention, including clinical settings and remote technologies, which could enhance access to exercise programs, especially in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ehealth technology in cardiac exercise therapeutics for pediatric patients with congenital and acquired heart conditions: a summary of evidence and future directions. White, DA., Layton, AM., Curran, T., et al.[2023]

In a study of 52 older patients (average age 68.2 years) with systolic heart failure, an 8-week supervised exercise program significantly improved physical fitness but did not affect key health markers like glucose levels or inflammation.

The lack of improvement in quality of life and other health indicators suggests that exercise training may not be as effective for older heart failure patients as it is for younger individuals, highlighting the need for more tailored research in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in older patients with systolic heart failure: adherence, exercise capacity, inflammation and glycemic control. Prescott, E., Hjardem-Hansen, R., Dela, F., et al.[2022]

Citations

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Physical activity modification in youth with congenital heart ... In this article, we review how increasing physical activity in youth with CHD may offer immediate and long-term cardiovascular benefits.

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Interactive Telehealth Solutions for Patients With ... It significantly improved outcomes for infants with hypoplastic left heart syndrome and single ventricle disease, reducing complications, emergency department ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X23016288

Review Exploring the Promise of Telemedicine Exercise ... In this review, we highlight the existing evidence basis for exercise interventions in youth with CHD, explore the promise of incorporating telemedicine home- ...

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Feasibility, Safety, and Efficacy of Pediatric Cardiac ... This randomized controlled trial of pediatric participants with heart disease demonstrated that pediatric cardiac telerehabilitation is feasible ...

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Interactive Telehealth Solutions for Patients With ... It significantly improved outcomes for infants with hypoplastic left heart syndrome and single ventricle disease, reducing complications, emergency department ...

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RePORT RePORTER - National Institutes of Health (NIH) | Our multidisciplinary team of experts will assess the effectiveness of a live-video-supervised exercise intervention, rigorously designed to maximize adherence ...

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Design and rationale of re-energize fontan: Randomized ... A live-video-supervised exercise (aerobic+resistance) intervention will improve cardiac and physical capacity; muscle mass, strength, and function; and ...