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NCT06918795 · ClinicalTrials.gov registry record · NA
Fontan Fitness Trial
A NA study of Congenital Heart Disease and Single-ventricle, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06918795: Recruiting NA study of Congenital Heart Disease and Single-ventricle, sponsored by Children's Hospital of Philadelphia.
NCT06918795 is a NA study of Congenital Heart Disease and Single-ventricle that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 200 participants, below the 471-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06918795, a NA study of Congenital Heart Disease and Single-ventricle, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
Change in total volume of physical activity (PA) operationalized as a Monitor Independent Movement Summary (MIMS) units, expressed as a percentile based on what is expected for their age and sex.
Conditions Studied
Interventions
- BEHAVIORAL Digital Exercise Intervention
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-06-09 |
| Est. Completion | 2029-04 |
| Phase | NA |
What NCT06918795 shows while recruiting
NCT06918795 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 471-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Digital Exercise Intervention is the first listed.
NCT06918795 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06918795 about?
NCT06918795 is a clinical study titled "Fontan Fitness 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 physi...
What is the current status of trial NCT06918795?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2025-06-09. Estimated completion is 2029-04.
What conditions does trial NCT06918795 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Single-ventricle.
What interventions are being tested in trial NCT06918795?
The interventions under investigation include: Digital Exercise Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06918795?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06918795 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06918795's enrollment target sits among peer trials
200 17th of 63 higher than 42 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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