Supervised Exercise for Single Ventricle Heart Condition
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Exercise Intervention
Participants in the exercise intervention arm will participate in live-video-supervised exercise sessions 3 times a week for 3 months
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Live-Video-Supervised Exercise Intervention
- Usual Care then Live-Video Supervised Exercise Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
The Methodist Hospital Research Institute
Collaborator