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.
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.
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]).
Parallel
Community-Based Remote Cardiac Rehabilitation Program
BehavioralThe 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.
standard of care
BehavioralParticipants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.
Change in Maximal Oxygen Consumption (VO2 max)
Measured by Cardiopulmonary Exercise Test (CPET) using the OSAKA protocol. It assesses the maximal amount of oxygen the body can utilize during exercise.
Change in Pediatric Quality of Life Inventory (PedsQL) Total Score
Health-related quality of life assessed by the PedsQL questionnaire. Total scores range from 0 to 100, where higher scores indicate a better outcome (higher health-related quality of life).
Cardiac Rehabilitation Program Attendance Rate
Calculated as the number of participated sessions divided by the total number of provided sessions (%).
Drop-out Rate
Percentage of participants who dropped out related to the intervention
Change in Physical Activity Level
Measured by an accelerometer (GENEActiv) worn for 7 days and smartwatch data.
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Seoul National University Hospital
Lead sponsor
University of Seoul
Collaborator
