Fontan Fitness Trial
Home-based, Digital Intervention to Increase Physical Activity in Patients With the Fontan Circulation
Children's Hospital of Philadelphia
200 participants
Jun 9, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Subjects randomized to the intervention arm will receive the same as the enhanced usual care arm but will be additionally exposed to: (1) personalized plans for aerobic-based PA, (2) personalized resistance exercise sessions, and (3) financial and non-financial engagement strategies. These intervention components will be delivered continuously using an advanced digital health informatics platform during the 6 months of the intervention. The intervention will be overseen and supplemented by the exercise physiologist, who will meet with participants on a weekly, then biweekly and finally monthly basis over 6 months.
Locations(1)
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NCT06918795