150 Participants Needed

Supervised Exercise for Single Ventricle Heart Condition

ST
Overseen BySeda Tierney
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With \>1,000 Fontan palliations performed in the US annually, there is a burgeoning population of Fontan patients at risk for progressive heart failure and death. Factors that contribute to onset and progression of heart failure in Fontan patients remain incompletely understood. However, it is established that Fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. In adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. Limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few Fontan patients. Furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. The investigators propose a milestone-driven, randomized controlled trial in pediatric Fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. The investigators' ultimate goal is the translation of this model to clinical application as an "exercise prescription" to intervene early in pediatric Fontan patients and decrease long-term morbidity and mortality.

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 data supports the effectiveness of the treatment Live-Video-Supervised Exercise Intervention for single ventricle heart condition?

Research shows that exercise interventions, including those using telemedicine, can improve physical activity levels and health outcomes in children with congenital heart disease. These programs can increase access to exercise for patients in remote areas, potentially improving their overall health and quality of life.12345

Is live-video-supervised exercise safe for people with heart conditions?

Research shows that live-video-supervised exercise is generally safe for people with heart conditions, including children and adolescents with congenital heart disease and pediatric heart transplant recipients. These studies found good adherence to the exercise programs and noted improvements in health without significant safety concerns.12367

How does the Live-Video-Supervised Exercise Intervention treatment differ from other treatments for single ventricle heart condition?

This treatment is unique because it uses live video to supervise exercise sessions, allowing patients to participate from home while still receiving guidance, which is different from traditional in-person supervised exercise programs. It combines exercise with dietary guidance and is designed to improve cardiovascular and functional health, making it a novel approach for managing heart conditions.168910

Eligibility Criteria

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.
See 2 more

Exclusion Criteria

I have not been seriously ill in the last 3 months.
I have severe heart failure.
You have a pacemaker implanted.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Live-Video-Supervised Exercise Control ArmExperimental Treatment1 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 ArmExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

FORCE Risk Stratification Tool for Pediatric Cardiac Rehabilitation and Fitness Programs. [2023]
Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. [2023]
ehealth technology in cardiac exercise therapeutics for pediatric patients with congenital and acquired heart conditions: a summary of evidence and future directions. [2023]
Exercise training in older patients with systolic heart failure: adherence, exercise capacity, inflammation and glycemic control. [2022]
Exercise training in patients with severe left ventricular dysfunction. Hemodynamic and metabolic effects. [2022]
Healthy Hearts via Live Videoconferencing: An Exercise and Diet Intervention in Pediatric Heart Transplant Recipients. [2021]
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). [2021]
Impact of a Supervised Twelve-Week Combined Physical Training Program in Heart Failure Patients: A Randomized Trial. [2022]
Current state of home-based exercise interventions in patients with congenital heart disease: a systematic review. [2020]
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. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security