Fontan Fitness Trial

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Single-ventricle; Congenital Heart Disease

Treatments: Behavioral: Digital Exercise Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06918795

24-022619

1R61HL171110-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Digital Exercise Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Digital Exercise Intervention

Enhanced Usual Care

No Intervention group

Description:

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.