Ireland
--:--IST
Recruiting Not applicable

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

NCT07572435 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2026-05-01
Last updated
2026-05-07

Condition(s) studied

Complex Congenital Heart Disease

Investigational drug(s) / intervention(s)

Community-Based Remote Cardiac Rehabilitation Programstandard of care

Community-Based Remote Cardiac Rehabilitation Program: The program consists of supervised remote exercise via ZOOM once a week (approx. 60 minutes, including warm-up, aerobic, resistance, respiratory, and cool-down exercises) and self-directed exercise 3 to 7 times a week. Biological signals (ECG, heart rate, SpO2) are monitored using wearable devices (mobiCARE, pulse oximeter, and smartwatch). A respiratory muscle training device (POWERbreathe) is also utilized.

standard of care: Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.

Study 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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
18 Years
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.

Primary outcome measure(s)

  • Change in Maximal Oxygen Consumption (VO2 max) — Baseline (Week 0), 12 weeks
    Measured by Cardiopulmonary Exercise Test (CPET) using the OSAKA protocol. It assesses the maximal amount of oxygen the body can utilize during exercise.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07572435 on ClinicalTrials.gov ↗ ← All trials in South Korea