An interventional study of Digital Exercise Intervention in Single-ventricle and Congenital Heart Disease, sponsored by Children's Hospital of Philadelphia. Recruiting at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
Among 55 studies in Univentricular Heart with a site in United States — 13 open to participants now, 16 under way, none of them phase 3. Univentricular Heart · United States.
Among the 55 studies in Univentricular Heart with a site in United States, this one has the largest planned enrollment of the 32 interventional ones that give a count, is one of 3 that started in 2025, is one of 17 with no phase, reaches primary completion later than 14 of the 15 other live ones, and was the 50th registered.
86 studies on the registry are indexed under Univentricular Heart; 22 are open to participants now.
Browse Univentricular Heart studies →13 of the 55 studies in Univentricular Heart with a site in United States are open now. Recruiting first, the newest first:
Le Bonheur Children's Hospital · Sites in United States
Ages 0 mo–12 mo
University of Texas Southwestern Medical Center · Sites in United States
Ages 18–45 · Healthy volunteers
Children's Hospital Los Angeles · Sites in United States
Ages 12–21
Driscoll Children's Hospital · Sites in United States
Ages 0 mo–6 mo
Boston Children's Hospital · Sites in United States
Ages 1 days–7 days
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Univentricular Heart studies recruiting now, 8 (38%) set no upper age limit and 13 (62%) stop at 75 or younger; 16 take children under 18; 1 takes healthy volunteers.
This study: 10 Years to 17 Years · all sexes · no healthy volunteers.
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55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 9 · Phase 3 4 · Phase 4 2
First in 2000; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 28 across 44 interventional studies indexed under Univentricular Heart.
Median enrollment 24 across the 32 interventional studies, 30 across the 23 observational. Of the 36 that completed or were terminated, 12 (33%) have results posted.
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2 of 55 have an industry lead sponsor. The 10 most frequent:
Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Children's Hospital of Philadelphia has 4 studies filed under Univentricular Heart — fewer than ten, so there is no comparison to draw.
5 of the studies in Univentricular Heart with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06434207Boston Children's HospitalExtracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis | 2026-12-01 |
| NCT06150950Stanford UniversityREHAB Fontan Failure: A Trial of Cardiac Rehabilitation | 2026-12-31 |
| NCT05262907Duke UniversityVentripoint Single Ventricle Study | 2027-08 |
| NCT05647213HeartWorks, Inc.Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease | 2027-09 |
| NCT07220226University of Texas Southwestern Medical CenterVenous Compression in Fontan | 2027-11-01 |
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Among the 55 studies in Univentricular Heart with a site in United States, from their registry updates:
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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:
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:
The Fontan Circulation is associated with poor exercise performance and reduced quality of life. Current standard of care encourages physical activity (PA) in this population, but few structured interventions exist. Participants will be randomly assigned to either enhanced usual care (PA tracker and standard encouragement) or an interactive digital intervention that includes personalized aerobic and resistance exercises with behavioral engagement strategies. This study will evaluate a home-based, digital intervention delivered through a mobile health platform to promote PA and improve fitness among youth with FC.
The study will recruit up to 200 participants aged 10-17 years with FC. After initial testing and a two-week run-in period, 120 participants with peak VO2 between 45% and 80% of predicted norms will be randomized. The intervention will last 6 months, followed by a 5.5-month monitoring phase. Outcomes will include changes in PA (measured via accelerometry), peak VO2, muscle strength, body composition, and quality of life.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The exercise intervention arm includes access to a digital application to receive the following over the 6-month intervention: * personalized plans for aerobic-based PA * personalized resistance exercise sessions * engagement strategies.
Behavioral: Digital Exercise Intervention
The enhanced usual care arm will receive their usual care in addition to a passive physical activity tracker device. No intervention materials will be delivered to these participants over the course of their enrollment in the study.
Subjects randomized to the intervention arm will receive the same as the enhanced usual care arm but will be additionally exposed to: (1) personalized plans for aerobic-based PA, (2) personalized resistance exercise sessions, and (3) financial and non-financial engagement strategies. These intervention components will be delivered continuously using an advanced digital health informatics platform during the 6 months of the intervention. The intervention will be overseen and supplemented by the exercise physiologist, who will meet with participants on a weekly, then biweekly and finally monthly basis over 6 months.
MIMS-units
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.
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Absolute peak VO2
Change in absolute peak VO2, the maximum amount of oxygen the body consumes during exercise without regard to body weight (liters/minute).
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Percent predicted peak VO2
Change in percent predicted peak VO2, the maximum amount of oxygen the body consumes during exercise expressed as a percentage of what is expected for their age and sex.
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Leg lean mass
Change in leg lean mass presented as a z-score. Leg lean mass z-score compares an individual's leg muscle mass to the average for their age and sex, with values below -2.0 indicating lower-than-expected muscle mass.
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
MVPA
Change in time spent in moderate to vigorous physical activity (MVPA), in terms of minutes per day.
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Forearm strength
Change in forearm strength measured via handgrip test and presented as a z-score. Z-scores are used to standardize measurements across individuals with different demographics (i.e. age, sex, body size).
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Lower extremity strength
Change in lower extremity strength measured via knee and ankle peak torsion and presented as a z-score.
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
PROMIS Pediatric Profile-25 T-score
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile-25. This 25-item questionnaire provides a T-score based on physical function, anxiety, depression, fatigue, peer relationships and pain. Children and parents will complete a PROMIS questionnaire. Children will answer questions about themselves and parents will answer questions in regard to their child.
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
PCQLI score
Change in Pediatric Cardiac Quality of Life Instrument (PCQLI) total and sub-scale scores (i.e. Disease Impact, Psychosocial Impact).The PCQLI is a cardiac-specific health-related quality-of-life instrument. Children will answer questions about themselves and parents will answer questions in regard to their child.
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Plan to share: No — NHLBI data sharing regulations will be followed. No data will be shared before study conclusion.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Apr 2029, 46 months after the start.
Of 20 interventional studies with no phase under Univentricular Heart, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 63. This study's planned 46 months is close to that.
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