Improving fitness for adolescents with the Fontan circulation
Home-based, Digital Intervention to Increase Physical Activity in Patients With the Fontan Circulation
This study will test whether a home-based digital exercise program helps 10–17-year-olds with the Fontan circulation become more active and improve fitness compared with enhanced usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06918795 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking 10–17-year-olds with a Fontan circulation who can complete exercise testing and study procedures and have a baseline peak VO2 between 45% and 80% of age- and sex-predicted norms.
Not a fit: Patients unlikely to benefit include those with peak VO2 below 45%, uncontrolled arrhythmias, pacemakers/ICDs, uncontrolled medical or lymphatic conditions, those listed for or after heart transplant, or those unable to complete exercise testing or study procedures.
Why it matters
Potential benefit: If successful, the program could increase daily physical activity and improve aerobic fitness, muscle strength, and quality of life for young people with a Fontan circulation.
How similar studies have performed: This approach is relatively novel for the Fontan population with few prior randomized interventions, though related home-based or digital cardiac rehabilitation programs in other cardiac groups have shown modest improvements in activity and fitness.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.