Fontan Fitness Trial: Digital Exercise for Single-Ventricle Heart Disease
This study, called the Fontan Fitness Trial, is looking at how a home-based digital exercise program can help children aged 10-17 with Fontan circulation (a type of single-ventricle congenital heart disease) improve their physical fitness and activity levels. Participants will be randomly assigned to either receive enhanced usual care (like a physical activity tracker and encouragement) or the digital exercise program. The digital program includes personalized plans for aerobic and resistance exercises, along with strategies to help you stay engaged. Researchers will compare these groups to see if the digital program increases physical activity and fitness. To join the main part of the study, your predicted peak VO2 (a measure of fitness) needs to be less than 80%.
- Study design
- This is an interventional, randomized controlled trial planning to enroll up to 200 participants. It compares a digital exercise intervention to enhanced usual care.
- What's involved
- If randomized, you would participate in a 6-month intervention, followed by a 5.5-month monitoring phase. This involves initial testing, a two-week run-in period, and measurements at 0, 6, and 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after starting the study, with measurements taken at 6 and 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Fontan Fitness Trial
At a glance
Conditions
NCT06918795
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Elizabeth Goldmuntz, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- MIMS-units0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Change in total volume of physical activity (PA) operationalized as a Monitor Independent Movement Summary (MIMS) units, expressed as a percentile based on what is expected for their age and sex.
- Absolute peak VO20 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Change in absolute peak VO2, the maximum amount of oxygen the body consumes during exercise without regard to body weight (liters/minute).
- Percent predicted peak VO20 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Change in percent predicted peak VO2, the maximum amount of oxygen the body consumes during exercise expressed as a percentage of what is expected for their age and sex.
- Leg lean mass0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Change in leg lean mass presented as a z-score. Leg lean mass z-score compares an individual's leg muscle mass to the average for their age and sex, with values below -2.0 indicating lower-than-expected muscle mass.