Fontan Fitness Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorChildren's Hospital of Philadelphia
About this trial
The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention. The main questions it aims to answer are:
* Does a home-based, digital intervention increase physical activity (PA) in youth with the FC compared to enhanced usual care? * Does a home-based, digital intervention increase physical fitness in youth with the FC compared to enhanced usual care? * Do multi-level factors (medical, neurodevelopmental, sociodemographic, neighborhood) impact the effectiveness of the digital intervention?
Researchers will compare participants in the enhanced usual care arm to those in the exercise intervention arm to see if the digital intervention is effective.
All participants will wear a PA tracker for 12 months and complete testing at baseline, 6 months, and 12 months.
In addition, participants in the exercise intervention arm will complete a 6-month exercise intervention with the following components:
* aerobic exercise * resistance exercise * engagement strategies
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Digital Exercise Intervention
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital of Philadelphia
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov