Home Exercise Program for Kids with Congenital Heart Disease
Fontan Fitness Trial
Recruiting
N/A
Interventional Study
Single-ventricle
Congenital Heart Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 10 – 17
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Children's Hospital of Philadelphia · Other
Who this trial is looking for
This trial is looking for children aged 10-17 with Fontan Circulation. Participants will take part in a home exercise program for 6 months while wearing a physical activity tracker for a year.
Are You a Good Fit for This Trial?
You may be able to join if
- I have Fontan Circulation.
- I am a girl aged 11 or older and have a negative urine pregnancy test.
- I can follow the study procedures.
- I speak English and have an English-speaking parent or guardian.
- I can perform the exercise stress test and my peak VO2 is less than 80% of the normal range.
You may not be able to join if
- I cannot complete an exercise stress test.
- I have uncontrolled lymphatic disorders.
- I have uncontrolled noncardiac conditions.
- I have exercise-induced or uncontrolled arrhythmias.
- I have a pacemaker or internal cardiac defibrillator.
- My peak VO2 is less than 45% of the normal range.
- I have had or am being considered for a heart transplant.
- I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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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…
Trial Locations
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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…
Contacts