Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease
Preliminary Efficacy of a Community-Based Remote Cardiac Rehabilitation Program on Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease: A Single Blind, Randomized Controlled Trial
Seoul National University Hospital
45 participants
May 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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.
Exclusion Criteria6
- 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.
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Interventions
The program consists of supervised remote exercise via ZOOM once a week (approx. 60 minutes, including warm-up, aerobic, resistance, respiratory, and cool-down exercises) and self-directed exercise 3 to 7 times a week. Biological signals (ECG, heart rate, SpO2) are monitored using wearable devices (mobiCARE, pulse oximeter, and smartwatch). A respiratory muscle training device (POWERbreathe) is also utilized.
Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.
Locations(1)
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NCT07572435