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

NCT07572435 | Recruiting

• 1 other identifier: 2511-022-1690
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Change in Maximal Oxygen Consumption (VO2 max)

  Measured by Cardiopulmonary Exercise Test (CPET) using the OSAKA protocol. It assesses the maximal amount of oxygen the body can utilize during exercise.

  Baseline (Week 0), 12 weeks

Secondary Outcomes (36)

• Change in Pediatric Quality of Life Inventory (PedsQL) Total Score

  Baseline (Week 0), 12 weeks, 24 weeks

• Cardiac Rehabilitation Program Attendance Rate

  12 weeks, 24 weeks

• Drop-out Rate

  12 weeks, 24 weeks

• Change in Physical Activity Level

  Baseline, 12 weeks, 24 weeks

• Change in Global Physical Activity Questionnaire (GPAQ) Score

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

Remote Cardiac Rehabilitation Group

EXPERIMENTAL

Participants randomly assigned to this group will receive a 12-week remote cardiac rehabilitation program followed by a 12-week follow-up period (total 24 weeks).

Behavioral: Community-Based Remote Cardiac Rehabilitation Program; Behavioral: standard of care

Control Group

ACTIVE COMPARATOR

Participants randomly assigned to this group will receive the standard of care for 24 weeks. After the 24-week evaluation, they will be offered a 1-month exercise education program opportunity.

Behavioral: standard of care

Interventions

Community-Based Remote Cardiac Rehabilitation Program BEHAVIORAL

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.

Remote Cardiac Rehabilitation Group

standard of care BEHAVIORAL

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

Control Group; Remote Cardiac Rehabilitation Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seoul: collaborator
• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Sungbae Jo Research Professor, Ph.D

CONTACT

82-2-2072-4178; sungbaejo@snuh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

KR (1)