Fontan Fitness Trial

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06918795
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Heart Disease
  • Single-ventricle

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Digital Exercise Intervention — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Jun 9, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital 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.
  • No Intervention: Enhanced 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.

Primary Outcome Measure

MIMS-units [ Time Frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Elizabeth Goldmuntz, MD
[email protected]
Zoe Lincoln, MS
[email protected]
Elizabeth Goldmuntz, MD (PRINCIPAL_INVESTIGATOR)
Jonathan Mitchell, PhD (SUB_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By research site
Children's Hospital of Philadelphia· Philadelphia, PA

Related Studies