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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
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.
Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.
Seoul National University Hospital
Seoul, South Korea
RECRUITINGChange 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.
Time frame: Baseline (Week 0), 12 weeks
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).
Time frame: 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 (%).
Time frame: 12 weeks, 24 weeks
Drop-out Rate
Percentage of participants who dropped out related to the intervention
Time frame: 12 weeks, 24 weeks
Change in Physical Activity Level
Measured by an accelerometer (GENEActiv) worn for 7 days and smartwatch data.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline, 12 weeks, 24 weeks
Incidence of Adverse Events (Safety)
Proportion and rate of adverse events and serious adverse events occurring during exercise.
Time frame: 12 weeks, 24 weeks
Change in Oxygen Consumption (VO2)
The volume of oxygen consumed per minute during the cardiopulmonary exercise test. Unit: L/min.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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: %.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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: %.
Time frame: 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: %.
Time frame: 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: %.
Time frame: 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: %.
Time frame: 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.
Time frame: 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: %.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 12 weeks, 24 weeks
Change in Upper Limb Strength (Grip Strength)
The maximum isometric handgrip strength measured using a hand dynamometer. Unit: kg.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks, 24 weeks
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