Status:
RECRUITING
Fontan Fitness Trial
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Conditions:
Single-ventricle
Congenital Heart Disease
Eligibility:
All Genders
10-17 years
Phase:
NA
Brief 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....
Detailed Description
The Fontan Circulation is associated with poor exercise performance and reduced quality of life. Current standard of care encourages physical activity (PA) in this population, but few structured inter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06918795
Start Date
June 9 2025
End Date
April 1 2029
Last Update
June 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104