Clinical Trial

Fontan Fitness Trial

Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention. The main questions it aims to answer are: * Does a home-based, digital intervention increase physical activity (PA) in youth with the FC compared to enhanced usual care? * Does a home-based, digital intervention increase physical fitness in youth with the FC compared to enhanced usual care? * Do multi-level factors (medical, neurodevelopmental, sociodemographic, neighborhood) impact the effectiveness of the digital intervention? Researchers will compare participants in the enhanced usual care arm to those in the exercise intervention arm to see if the digital intervention is effective. All participants will wear a PA tracker for 12 months and complete testing at baseline, 6 months, and 12 months. In addition, participants in the exercise intervention arm will complete a 6-month exercise intervention with the following components: * aerobic exercise * resistance exercise * engagement strategies
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-04-02; most recent amendment 2026-04-07.
Status change: Not Yet Recruiting → Recruiting 2025-05-27
Trial Details
NCT Number NCT06918795
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania
Conditions Single-ventricle, Congenital Heart Disease
Enrollment 200 participants
Start Date 2025-06-09
Primary Completion 2029-04 (estimated)
Study Completion 2029-04 (estimated)
Updated on ClinicalTrials.gov 2026-04-13