Improving fitness for adolescents with the Fontan circulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will randomize eligible youth with the Fontan circulation to either enhanced usual care (activity tracker and standard encouragement) or a personalized, interactive digital exercise program delivered through a mobile platform. Participants will wear an activity tracker for 12 months and complete baseline, 6-month, and 12-month testing including peak VO2, strength, body composition, and quality-of-life measures. The randomized intervention phase lasts 6 months followed by a monitoring period, and the trial uses accelerometry to quantify changes in physical activity. The study will also analyze medical, neurodevelopmental, sociodemographic, and neighborhood factors that might influence the program's effectiveness.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Elizabeth Goldmuntz, MD — Children's Hospital of Philadelphia
• Study coordinator: Elizabeth Goldmuntz, MD
• Email: goldmuntz@chop.edu
• Phone: 215-590-3354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.