Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-06-09
2029-04-30
Brief Summary
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* 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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
17 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pennsylvania
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Goldmuntz, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-022619
Identifier Type: -
Identifier Source: org_study_id
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