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Clinical Trial NCT06918795 for Single-ventricle, Congenital Heart Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Fontan Fitness Trial

Recruiting
Clinical Trial NCT06918795 is an interventional study for Single-ventricle, Congenital Heart Disease that is recruiting. It started on June 9, 2025 with plans to enroll 200 participants. Led by Children's Hospital of Philadelphia, it is expected to complete by April 1, 2029. The latest data from ClinicalTrials.gov was last updated on June 11, 2025.
Brief 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
Detailed Description
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.

Official Title

Home-based, Digital Intervention to Increase Physical Activity in Patients With the Fontan Circulation

Conditions
Single-ventricleCongenital Heart Disease
Other Study IDs
NCT ID Number
NCT06918795
Start Date (Actual)
2025-06-09
Last Update Posted
2025-06-11
Completion Date (Estimated)
2029-04
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Fontan
Single ventricle disease
exercise intervention
digital health
adolescents
randomized control trial
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDigital Exercise Intervention
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.
Digital Exercise Intervention
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.
No InterventionEnhanced Usual Care
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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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).
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.
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.
0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
MVPA
Change in time spent in moderate to vigorous physical activity (MVPA), in terms of minutes per day.
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).
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.
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.
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.
0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Eligibility Criteria

Eligible Ages
Child
Minimum Age
10 Years
Eligible Sexes
All
  • 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 randomized 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
  • 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 subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Children's Hospital of Philadelphia logoChildren's Hospital of Philadelphia
Study Central Contact
Contact: Elizabeth Goldmuntz, MD, 215-590-3354, [email protected]
Contact: Zoe Lincoln, MS, [email protected]
1 Study Locations in 1 Countries

Pennsylvania

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Elizabeth Goldmuntz, MD, Contact, [email protected]
Zoe Lincoln, MS, Contact, [email protected]
Elizabeth Goldmuntz, MD, Principal Investigator
Jonathan Mitchell, PhD, Sub-Investigator
Recruiting