RandomizEd Exercise iNtERvention desiGned to maximIZE fitness in pediatric FONTAN patients
RE-ENERGIZE FONTAN study is a new study that evaluates whether exercise can improve not only the quality of life but also long-term outcomes in children and adolescents with Fontan circulation.
The aim of this study is to evaluate if a live-video-supervised exercise intervention can improve cardiac and physical capacity, endothelial function, and muscle mass and function in children and adolescents with Fontan circulation.
What is the Intervention?
Participants will initially be enrolled in the usual care or exercise intervention arm.
And... by the end of the study, everyone will get to exercise!
Participants in the intervention arm will exercise of 3x/week with the trainer via live-video exercise conferencing in small groups for 3 months. They will then enter a 6-month phase where they do live-video-supervised exercise sessions only 1x/week and exercise on their own 2x/week.
Participants in the usual care arm will be in usual care for 9 months and then will exercise 3x/week with the trainer via live-video exercise conferencing in small groups for 3 months.
As a part of the intervention, all participants will get a tablet, a Fitbit, and an exercise kit (medicine ball, foam roller, sliders, and resistance bands) when they start the exercise phase. Participants will get to keep all of these items for personal use after the end of the study.
What is Our Target Enrollment?
We plan to enroll 150 participants over 5 years at Stanford Child Health at LPCH.
Who Can Participate?
Participants 8 to 19 years with Fontan circulation who are cleared to exercise by their primary cardiologist.
Participants will be asked to come in for 3-4 times for in-person study visits over the course of a year.
During each visit participants will receive a $150 Amazon gift card.
Study Visit Testing
During each study visit, our team of experts will performs a comprehensive assessment of cardiac and physical capacity, endothelial function, and muscle strength and mass of our Fontan study patients. Each study visit will last approximately 6 hours, with time for a short lunch break.
-The following non-invasive tests will be administered at each visit:
· Strain Echocardiography
· Cardiopulmonary Exercise Stress Testing
· Functional Movement Screening
· Magnetic Resonance Imaging
· Dual X-ray Absorptiometry (DEXA) to assess muscle mass
· Muscle Function and Strength Testing
· Blood Draw (under 1 tablespoon)