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Fontan Fitness Trial

RecruitingNAAges 10 Years - 17 YearsAllChildren's Hospital of Philadelphia
NCT06918795 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 1

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📋 Eligibility rules (as published)
Inclusion Criteria: * Fontan Circulation present * Girls ≥11 years of age or menstruating must have negative urine pregnancy test * Neurodevelopmental capacity to complete all study procedures * Physical capacity to complete all study procedures * English speaking with at least one English speaking parent/guardian * To enroll in the randomized control trial, percent predicted peak VO2 \<80% of age-sex matched normal controls on the baseline exercise stress test (EST) Exclusion Criteria: * Inability to complete an EST at any time (i.e. limited physical or executive function) * Uncontrolled lymphatic disorders * Uncontrolled noncardiac conditions * Exercise induced or uncontrolled arrhythmias * Pacemaker or internal cardiac defibrillator (ICD) * Peak VO2 \<45% age-sex predicted * Having had or under consideration for a heart transplant * Pregnant or lactating females * Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
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What it tests

  • Digital Exercise Intervention
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Where

1 site
Children's Hospital of Philadelphia
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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