Recruiting

Digital Exercise Intervention

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT06918795

Conditions

Single-ventricle

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Digital Exercise Intervention

Study Details

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

Study ID

NCT06918795

Start date

Jun 9, 2025

Status verified date

Apr, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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 exercise physiologist, who will meet with participants on a weekly, then biweekly and finally monthly basis over 6 months.

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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Elizabeth Goldmuntz, MD

215-590-3354goldmuntz@chop.edu

Zoe Lincoln, MS

lincolnz@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Elizabeth Goldmuntz, MD

goldmuntz@chop.edu

Zoe Lincoln, MS

lincolnz@chop.edu

Principal Investigator:

Elizabeth Goldmuntz, MD

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-04-13.