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

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

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 Overview

• Status: Recruiting
• Conditions: Complex Congenital Heart Disease
• Intervention / Treatment: Behavioral: Community-Based Remote Cardiac Rehabilitation Program; Behavioral: standard of care

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sungbae Jo Research Professor, Ph.D; Phone Number: 82-2-2072-4178; Email: sungbaejo@snuh.org

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Sungbae Jo Research Professor, Ph.D; Phone Number: 82-2-2072-4178; Email: sungbaejo@snuh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Cardiac Rehabilitation Group; 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; 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.
Active Comparator: Control Group; 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; Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pediatric Quality of Life Inventory (PedsQL) Total Score	Health-related quality of life assessed by the PedsQL questionnaire. Total scores range from 0 to 100, where higher scores indicate a better outcome (higher health-related quality of life).	Baseline (Week 0), 12 weeks, 24 weeks
Cardiac Rehabilitation Program Attendance Rate	Calculated as the number of participated sessions divided by the total number of provided sessions (%).	12 weeks, 24 weeks
Drop-out Rate	Percentage of participants who dropped out related to the intervention	12 weeks, 24 weeks
Change in Physical Activity Level	Measured by an accelerometer (GENEActiv) worn for 7 days and smartwatch data.	Baseline, 12 weeks, 24 weeks
Change in Global Physical Activity Questionnaire (GPAQ) Score	Assesses levels of physical activity in three domains (activity at work/school, travel to and from places, recreational activities) and sedentary behavior. The Global Physical Activity Questionnaire (GPAQ) calculates physical activity volume in Metabolic Equivalent of Task (MET)-minutes per week, with a minimum value of 0 and no defined maximum limit, where higher values indicate a better outcome (greater physical activity).	Baseline, 12 weeks, 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) Parent Proxy-Report Score	Assesses health-related quality of life of the pediatric patient from the perspective of the parents or guardians. Total scores range from 0 to 100, where higher scores indicate a better outcome (higher health-related quality of life).	Baseline, 12 weeks, 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score	A disease-specific module designed to measure health-related quality of life specifically in pediatric patients with heart disease. Total scores range from 0 to 100, where higher scores indicate a better outcome (better disease-specific quality of life).	Baseline, 12 weeks, 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Parent Proxy-Report Score	A disease-specific module designed to measure health-related quality of life specifically in parent proxy-report of pediatric patients with heart disease. Total scores range from 0 to 100, where higher scores indicate a better outcome (better disease-specific quality of life).	Baseline, 12 weeks, 24 weeks
Change in Resilience Scale for Youth (RS-Y) Score	Assesses the level of psychological resilience in children and adolescents. Total scores range from 37 to 185 (based on 37 items), where higher scores indicate a better outcome (greater psychological resilience).	Baseline, 12 weeks, 24 weeks
Change in Child Behavior Checklist (CBCL) Score	Evaluates behavioral and emotional problems in children and adolescents, as reported by parents or guardians. Results are reported as T-scores typically ranging from 28 to 100, where higher scores indicate a worse outcome (more severe behavioral or emotional problems).	Baseline, 12 weeks, 24 weeks
Change in Korean Children's Depression Inventory 2: Self-Report (K-CDI-2:SR) Score	A self-report assessment to evaluate the presence and severity of depressive symptoms in children and adolescents. Scores range from 0 to 56, where higher scores indicate a worse outcome (more severe depressive symptoms).	Baseline, 12 weeks, 24 weeks
Change in Revised Children's Manifest Anxiety Scale, Second Edition (RCMAS-2) Score	A self-report instrument designed to assess the level and nature of anxiety in children and adolescents. Results are reported as scores typically ranging from 0 to 40, where higher scores indicate a worse outcome (greater severity of anxiety).	Baseline, 12 weeks, 24 weeks
Incidence of Adverse Events (Safety)	Proportion and rate of adverse events and serious adverse events occurring during exercise.	12 weeks, 24 weeks
Change in Oxygen Consumption (VO2)	The volume of oxygen consumed per minute during the cardiopulmonary exercise test. Unit: L/min.	Baseline, 12 weeks, 24 weeks
Change in Carbon Dioxide Production (VCO2)	The volume of carbon dioxide produced per minute during the cardiopulmonary exercise test. Unit: L/min.	Baseline, 12 weeks, 24 weeks
Change in Respiratory Exchange Ratio (RER)	The ratio of carbon dioxide production to oxygen consumption during the cardiopulmonary exercise test. Unit: Ratio	Baseline, 12 weeks, 24 weeks
Change in Minute Ventilation (VE)	The total volume of air inhaled and exhaled per minute during the cardiopulmonary exercise test. Unit: L/min.	Baseline, 12 weeks, 24 weeks
Change in Ventilatory Equivalent for Oxygen (VE/VO2)	The ratio of minute ventilation to oxygen consumption, reflecting ventilatory efficiency. Unit: Ratio	Baseline, 12 weeks, 24 weeks
Change in Ventilatory Equivalent for Carbon Dioxide (VE/VCO2)	The ratio of minute ventilation to carbon dioxide production, reflecting ventilatory efficiency. Unit: Ratio	Baseline, 12 weeks, 24 weeks
Change in Oxygen Pulse (O2 Pulse)	The amount of oxygen consumed per heart beat during the cardiopulmonary exercise test. Unit: mL/beat.	Baseline, 12 weeks, 24 weeks
Change in Peripheral Capillary Oxygen Saturation (SpO2)	The blood oxygen saturation level measured via pulse oximetry during the cardiopulmonary exercise test. Unit: %.	Baseline, 12 weeks, 24 weeks
Change in Maximal Heart Rate (HRmax)	The highest heart rate achieved during the cardiopulmonary exercise test. Unit: beats per minute (bpm).	Baseline, 12 weeks, 24 weeks
Change in Skeletal Muscle Mass measured by Bioelectrical Impedance Analysis (BIA)	The total weight of skeletal muscle in the body measured by bioelectrical impedance analysis. Unit: kg.	Baseline, 12 weeks, 24 weeks
Change in Fat Mass measured by Bioelectrical Impedance Analysis (BIA)	The total weight of fat in the body measured by bioelectrical impedance analysis. Unit: kg.	Baseline, 12 weeks, 24 weeks
Change in Percent Body Fat measured by Bioelectrical Impedance Analysis (BIA)	The percentage of total body weight that consists of fat, measured by bioelectrical impedance analysis. Unit: %.	Baseline, 12 weeks, 24 weeks 13.
Change in Abdominal Fat Ratio measured by Bioelectrical Impedance Analysis (BIA)	The ratio of abdominal fat, evaluated by waist-to-hip circumference ratio via bioelectrical impedance analysis. Unit: %.	Baseline, 12 weeks, 24 weeks
Change in Extracellular Water Ratio measured by Bioelectrical Impedance Analysis (BIA)	The ratio of extracellular water to total body water, measured by bioelectrical impedance analysis. Unit: %.	Baseline, 12 weeks, 24 weeks
Change in Radial Artery Augmentation Index (AIx)	A measure of arterial stiffness derived from the radial artery pulse wave, standardized to a heart rate of 75 bpm (AIx@75). Unit: %.	Baseline, 12 weeks, 24 weeks
Change in Carotid-femoral Pulse Wave Velocity (c-f PWV)	The speed of the arterial pulse propagating from the carotid to the femoral artery, reflecting arterial stiffness. Unit: m/s.	Baseline, 12 weeks, 24 weeks
Change in Flow-Mediated Dilation (FMD)	The percentage increase in brachial artery diameter following a period of ischemia, assessing endothelial function. Unit: %.	Baseline, 12 weeks, 24 weeks
Change in 6-Minute Walk Test (6MWT) Distance	The total distance a participant can walk on a flat, hard surface in exactly 6 minutes. Unit: meters (m).	Baseline, 12 weeks, 24 weeks
Change in Lower Limb Strength measured by isokinetic dynamometer (Biodex)	The maximum isometric knee extension peak torque measured by an isokinetic dynamometer. Unit: Newton meters (N.m).	Baseline, 12 weeks, 24 weeks
Change in Lower Limb Muscular Endurance measured by 1-minute squats	The total number of chair stand squats completed within exactly one minute. Unit: repetitions.	Baseline, 12 weeks, 24 weeks
Change in Upper Limb Strength (Grip Strength)	The maximum isometric handgrip strength measured using a hand dynamometer. Unit: kg.	Baseline, 12 weeks, 24 weeks
Change in Flexibility measured by sit and reach test	The maximum distance reached forward while sitting with legs extended, assessing lower back and hamstring flexibility. Unit: cm.	Baseline, 12 weeks, 24 weeks
Change in Maximal Inspiratory Pressure (MIP)	The maximum pressure generated during inspiration against an occluded airway, assessing respiratory muscle strength. Unit: mmH2O.	Baseline, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: University of Seoul

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2511-022-1690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No