Home-based, Digital Intervention to Increase Physical Activity in Patients With the Fontan Circulation
Sponsor: Children's Hospital of Philadelphia
Trial Details
| Condition | Single-ventricle, Congenital Heart Disease |
| Intervention | Digital Exercise Intervention |
| Phase | NA |
| Status | Recruiting |
| Participants | 200 |
| Est. Completion | 1 Apr 2029 |
| Last Updated | 13 Apr 2026 |
Primary Outcome
MIMS-units; Absolute peak VO2; Percent predicted peak VO2; Leg lean mass
Eligibility Criteria
Inclusion Criteria
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
Trial Sites
Countries
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