Actively Recruiting
Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease
Led by Seoul National University Hospital · Updated on 2026-05-07
45
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
U
University of Seoul
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 8 to 18 years.
- Diagnosed with complex congenital heart disease 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 survey indicating moderate-to-vigorous physical activity time of less than 420 minutes per week.
You will not qualify if you...
- 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.
- Inability to cooperate with study tests such as Cardiopulmonary Exercise Test, Electrocardiogram, and 6-Minute Walk Test.
- Currently wearing an artificial pacemaker.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
S
Sungbae Jo Research Professor, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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