RecruitingNANCT06918795

Home-based, Digital Intervention to Increase Physical Activity in Patients With the Fontan Circulation

Sponsor: Children's Hospital of Philadelphia

Trial Details

ConditionSingle-ventricle, Congenital Heart Disease
InterventionDigital Exercise Intervention
PhaseNA
StatusRecruiting
Participants200
Est. Completion1 Apr 2029
Last Updated13 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

United States
View Registry Entry

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