NCT07572435RecruitingNot Applicable
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
Seoul National University Hospital1 site in 1 country45 target enrollmentStarted: May 1, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 45
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Sung Eun Hyun
Associate Professor
Seoul National University Hospital
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 1/2
Home-based rehabilitation in post-cardiac surgery patientsCTRI/2026/03/105222Shalinitai Meghe Hospital and Research Center Nagpur80
Completed
Not Applicable
Tele-rehabilitation Versus Center-based Rehabilitation in Heart Failure PatientsCardiac RehabilitationHeart FailureNCT07539493Azienda Ospedaliero Universitaria di Sassari30
Recruiting
Not Applicable
TeleheartCR vs. Clinic-Based Cardiac Rehabilitation After Acute Coronary SyndromeAcute Coronary Syndrome (ACS)Myocardial InfarctionNCT07541014Columbia University250
Active, not recruiting
Phase 1
To check the functional ability of patient and Quality of life by giving Cardiac Rehabilitation to patients with heart surgeryCTRI/2024/06/068230Physiotherapy school and center Seth G S Medcial college and KEMH60
Recruiting
Not Applicable
Remote Ischemic Conditioning for PwSCINCT07488793Washington University School of Medicine24