Status:
NOT_YET_RECRUITING
Community-Based Remote Cardiac Rehabilitation Program for Pediatric Patients With Complex Congenital Heart Disease
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
University of Seoul
Conditions:
Congenital Heart Disease (CHD)
Complex Congenital Heart Disease
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief Summary
This study is to develop a 12-week community-based remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease and to assess its validity and safety. For these ...
Eligibility Criteria
Inclusion
- Aged between 8 and 18 years
- Diagnosed with complex congenital heart disease (Complex CHD) and have undergone surgery
- At least 3 months post-cardiac surgery with a stable hemodynamic status
- Capable of using remote programs (e.g., mobile apps, video-conferencing platforms) at home, with technical support from a caregiver
- Either the participant or their caregiver agrees to study participation and has signed the informed consent form
Exclusion
- Patients with uncontrolled arrhythmias, acute heart failure, myocarditis, pericarditis, or other ongoing cardiovascular conditions.
- Patients who are unable to exercise independently due to neurological or musculoskeletal disorders.
- Patients who cannot understand or carry out remote rehabilitation program instructions due to cognitive impairment.
- Patients showing clinically significant levels of depression or anxiety on the CDI-2 or RCMAS.
- Patients who cannot cooperate with required study assessments (e.g., CPET, ECG, 6MWT).
Key Trial Info
Start Date :
May 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06912412
Start Date
May 31 2025
End Date
December 31 2029
Last Update
April 4 2025
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080