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RECRUITING
NCT07572435
NA

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

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

8 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-05-01

Completion Date

2029-12-31

Last Updated

2026-05-07

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

BEHAVIORAL

standard of care

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea