Fontan Fitness Trial

Official title

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

Overview

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.

Interventions

• Behavioral 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 e

Primary outcome measures

• MIMS-units [Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.]
• Absolute peak VO2 [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 [Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.]
• Leg lean mass [Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.]

Secondary outcome measures (5)

• MVPA [Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.]
• Forearm strength [Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.]
• Lower extremity strength [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 [Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.]
• PCQLI score [Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.]

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
• Uncontrolled noncardiac conditions
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Children's Hospital of Philadelphia — Philadelphia

Identifiers

NCT: NCT06918795 · 24-022619 · 1R61HL171110-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗