Home-Based Digital Exercise Program to Improve Fitness and Physical Activity in Youth Ages 10-17 With Fontan Circulation

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 interventions 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 programs effects.

Fontan Fitness Trial