Actively Recruiting
Home-based Digital Exercise Intervention to Increase Physical Activity and Fitness in Children and Teens with Fontan Circulation
Led by Children's Hospital of Philadelphia · Updated on 2026-04-13
200
Participants Needed
1
Research Sites
N/A
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
This research aims to learn about physical fitness and exercise habits in children aged 10 to 17 years who have the Fontan Circulation, a condition linked to reduced exercise ability and quality of life. The study compares a home-based digital exercise program with enhanced usual care to see if the digital approach can increase physical activity and improve fitness. Researchers will also explore how medical, developmental, social, and neighborhood factors might affect the digital intervention's success. Participants will be randomly assigned to one of two groups. One group receives enhanced usual care with a physical activity tracker and standard encouragement. The other group gets access to a digital app offering personalized aerobic and resistance exercise plans along with engagement strategies. The exercise program lasts for six months, followed by a 5.5-month monitoring phase. The study uses a mobile health platform to deliver the intervention and tracks activity continuously. Participants will wear a physical activity tracker for 12 months and complete assessments at the start, 6 months, and 12 months. These include tests of physical activity levels, peak oxygen consumption, muscle strength, body composition, and quality of life. The exercise intervention group will have support from an exercise physiologist with decreasing meeting frequency over the 6-month program. The study measures changes in activity and fitness to understand the digital program's effects.
CONDITIONS
Brief Title
Fontan Fitness Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fontan Circulation is present
- Girls aged 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 participant 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 (EST)
You will not qualify if you...
- Inability 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 current consideration for heart transplant
- Pregnant or lactating females
- Participants or guardians who may be non-compliant with study schedules or procedures according to investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants complete a two-week period to establish baseline physical activity levels before randomization.
1 visit (in-person)
Duration - 6 months
Participants are randomly assigned to either an enhanced usual care group or a digital exercise intervention group aimed at increasing physical activity and fitness through personalized aerobic and resistance exercises using a mobile health platform.
Weekly visits initially, then biweekly and monthly visits over 6 months
Duration - 5.5 months
Participants are monitored for 5.5 months after the intervention to observe ongoing physical activity and fitness outcomes.
Visits as scheduled for monitoring
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
Z
Zoe Lincoln, MS
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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