About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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]).
Trial design
Treatments tested in this trial
- Community-Based Remote Cardiac Rehabilitation Program
- standard of care
Treatment groups
Sponsors and collaborators
Seoul National University Hospital
Lead sponsor
University of Seoul
Collaborator