Fontan Fitness Trial
NCT06918795
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
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 * 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
Conditions3
Locations1 site
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT06918795