Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease

Recruiting now · Not applicable

Conditions studied: Complex Congenital Heart Disease

In brief

This study aims to evaluate the preliminary efficacy of a 12-week community-based remote cardiac rehabilitation program on cardiopulmonary function and quality of life in pediatric patients (aged 8 to 18 years) with complex congenital heart disease. Participants will be randomly assigned to either an experimental group receiving the remote cardiac rehabilitation program or a control group receiving the standard of care.

Key facts

Study ID

NCT07572435

Run by

Seoul National University Hospital

People needed

45

Starts

2026-05-01

Expected to finish

2029-12-31

Last updated by the study team

2026-05-07

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 8 to 18 years.
• Diagnosed with complex congenital heart disease (e.g., single ventricle, transposition of the great arteries) and have a history of cardiac surgery.
• At least 3 months post-cardiac surgery and maintaining a stable hemodynamic status.
• Capable of utilizing remote programs (mobile apps, video platforms, etc.) in the home environment with technical support from guardians.
• Participant or guardian has agreed to participate and signed the written informed consent form.
• Confirmed to have decreased physical activity level and physical well-being through assessments (Must meet both):
• KIDSCREEN-27 Parent Proxy-report 'Physical well-being' domain T-score of 40 or below.
• Exercise Vital Sign (EVS) survey indicating moderate-to-vigorous physical activity (MVPA) time of less than 420 minutes per week.

You may not qualify if…

• Ongoing cardiovascular diseases such as uncontrolled arrhythmia, acute heart failure, myocarditis, or pericarditis.
• Neurological or musculoskeletal disorders that make independent exercise impossible.
• Cognitive impairment that prevents understanding or following the instructions of the remote rehabilitation program.
• Clinical levels of depression or anxiety restricting exercise participation, as determined by the attending physician (assessed via Korean Children's Depression Inventory 2: Self-Report [K-CDI-2:SR] and Revised Children's Manifest Anxiety Scale, Second Edition [RCMAS-2]).
• Inability to cooperate with study tests, such as the Cardiopulmonary Exercise Test (CPET), Electrocardiogram (ECG), and 6-Minute Walk Test (6MWT).
• Currently wearing an artificial pacemaker.

Where it is running

• Seoul National University Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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