Clinical trial NCT06918795: Fontan Fitness Trial
Official title: Home-based, Digital Intervention to Increase Physical Activity in Patients With the Fontan Circulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Single-ventricle
Congenital Heart Disease
Keywords: Fontan
Single ventricle disease
exercise intervention
digital health
adolescents
randomized control trial
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Pennsylvania
First posted: 2025-04-09
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion 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 randomized control trial, percent predicted peak VO2 \<80% of age-sex matched normal controls on the baseline exercise stress test (EST)

Exclusion Criteria:

* 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

Primary outcomes:
measure: MIMS-units
timeFrame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
measure: Absolute peak VO2
timeFrame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
measure: Percent predicted peak VO2
timeFrame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
measure: Leg lean mass
timeFrame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Secondary outcomes:
measure: MVPA
timeFrame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
measure: Forearm strength
timeFrame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
measure: Lower extremity strength
timeFrame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
measure: PROMIS Pediatric Profile-25 T-score
timeFrame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
measure: PCQLI score
timeFrame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Elizabeth Goldmuntz, MD
role: PRINCIPAL_INVESTIGATOR
References: