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โ† Trials
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Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease

RecruitingNAAges 8 Years - 18 YearsAllSeoul National University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Community-Based Remote Cardiac Rehabilitation Program
  • standard of care
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Where

1 site
Seoul National University Hospital
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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