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Official title Fontan Fitness Trial
ClinicalTrials.gov ID: NCT06918795
What this study is testing
- What it's testing
- 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?
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- 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
You likely can't join if
- 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
- Pacemaker or internal cardiac defibrillator (ICD)
- Peak VO2 \<45% age-sex predicted
See the full eligibility 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 assigned by chance control trial, percent predicted peak VO2 \<80% of age-sex matched normal controls on the baseline exercise stress test (EST)
- 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
- 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 people who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.