An interventional study of Live-Video-Supervised Exercise Intervention and Usual Care then Live-Video Supervised Exercise Intervention in Single-ventricle, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 8 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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.
104 studies on the registry are indexed under Univentricular Heart; 22 are open to participants now.
This study's enrollment of 150 is above the median of 25 across 58 interventional studies indexed under Univentricular Heart.
Browse Univentricular Heart studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Live-Video-Supervised Exercise 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.
Other: Usual Care then Live-Video Supervised Exercise Intervention
The live-video-supervised exercise intervention includes exercise sessions x3/week for 3 months, and then maintenance regimen for 6 months. Maintenance includes live-video-supervised exercise sessions, only x1/week, and self-exercise x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker.
Patients randomized to usual care at baseline will receive usual care for 9 months and will then start the live-video-supervised exercise intervention that includes exercise sessions x3/week for 3 months.
Change in volume of Oxygen Consumed at Maximal Exertion
In Fontan patients, peak VO2 is a powerful predictor of poor outcomes. The subjects will undergo progressive cardiopulmonary exercise testing with continuous monitoring by 12-lead EKG and gas exchange by measuring breath-to-breath ventilation. Exercise capacity will be measured by a cardiopulmonary exercise test to obtain the peak VO2
Time frame: Baseline, 3 months, 9 months, 12 months
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stanford University