Fontan Fitness Trial

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Apr 2, 2025

Keywords

ClinConnect Summary

The Fontan Fitness Trial is a research study aimed at understanding how a home-based exercise program can help improve physical fitness and activity levels in children aged 10 to 17 who have a specific heart condition called Fontan Circulation. The study will compare two groups of participants: one group will follow an enhanced usual care plan, while the other group will participate in a digital exercise program for six months that includes activities like aerobic and resistance exercises. Researchers want to see if this digital program can help kids be more active and fit compared to those receiving standard care.

To be eligible for the trial, children must have Fontan Circulation and be between 10 to 17 years old. Girls who are 11 or older need to have a negative pregnancy test. Participants will wear a physical activity tracker for a year and will undergo fitness tests at the start, six months in, and again at the end of the study. Importantly, this trial is not recruiting participants yet, but it will provide valuable insights into how to support the health and fitness of young people with this heart condition.

Gender

ALL

Eligibility 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
• • 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