Actively Recruiting
Fontan Fitness Trial
Led by Children's Hospital of Philadelphia · Updated on 2026-04-13
200
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Fontan Fitness Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fontan Circulation present
- Girls 11 years or older or menstruating must have a negative urine pregnancy test
- Neurodevelopmental ability to complete all study procedures
- Physical ability to complete all study procedures
- English speaking with at least one English speaking parent or guardian
- Percent predicted peak VO2 less than 80% of age-sex matched normal controls on baseline exercise stress test
You will not qualify if you...
- Unable to complete an exercise stress test at any time
- Uncontrolled lymphatic disorders
- Uncontrolled noncardiac medical conditions
- Exercise induced or uncontrolled arrhythmias
- Presence of pacemaker or internal cardiac defibrillator (ICD)
- Peak VO2 less than 45% of age-sex predicted
- History of or consideration for heart transplant
- Pregnant or lactating females
- Potential non-compliance with study schedule or procedures as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
E
Elizabeth Goldmuntz, MD
CONTACT
Z
Zoe Lincoln, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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