12-week home heart rehabilitation program for children 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
This program will test whether a 12-week remote cardiac rehabilitation program can improve heart and lung fitness and quality of life in children aged 8–18 with complex congenital heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07572435 on ClinicalTrials.gov |
What this trial studies
Children aged 8 to 18 who are at least three months post-cardiac surgery and have reduced physical activity will be enrolled. Participants are randomly assigned to a 12-week community-based remote cardiac rehabilitation program delivered via mobile apps and video platforms or to standard of care. Outcomes include cardiopulmonary function and quality of life measured before and after the program, with remote monitoring and guardian technical support. The trial tests preliminary efficacy and feasibility of delivering rehabilitation in the home setting for patients with complex congenital heart disease.
Who should consider this trial
Good fit: Ideal candidates are children 8–18 years old with complex congenital heart disease who are at least three months post-surgery, hemodynamically stable, have low physical activity by EVS and KIDSCREEN-27 scores, and can use home remote technology with guardian support.
Not a fit: Patients with uncontrolled arrhythmias, acute heart failure, myocarditis, pericarditis, those unable to use remote technology, or those already meeting recommended activity levels are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could improve cardiopulmonary fitness and day-to-day wellbeing while making rehabilitation more accessible without frequent hospital visits.
How similar studies have performed: Home- and remotely delivered cardiac rehabilitation has shown benefits in adults and in some small pediatric reports, but robust evidence specifically for remote programs in complex congenital heart disease remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Sungbae Jo Research Professor, Ph.D
- Email: sungbaejo@snuh.org
- Phone: 82-2-2072-4178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.