Fontan Fitness Trial

NCT06918795 | Recruiting DMC

• 2 other identifiers: 24-0226191R61HL171110-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Single-ventricle; Congenital Heart Disease

Keywords

Fontan; Single ventricle disease; exercise intervention; digital health; adolescents; randomized control trial

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• MVPA

  0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.

• Forearm strength

  0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.

• Lower extremity strength

  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

  0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.

• PCQLI score

  0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.

Study Arms (2)

Digital Exercise Intervention

EXPERIMENTAL

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.

Behavioral: Digital Exercise Intervention

Enhanced Usual Care

NO INTERVENTION

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.

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.

Digital Exercise Intervention

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Univentricular Heart; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Elizabeth Goldmuntz, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Goldmuntz, MD

CONTACT

215-590-3354; goldmuntz@chop.edu

Zoe Lincoln, MS

CONTACT

lincolnz@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)