Complex Congenital Heart Disease
Conditions
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.
Interventions
BEHAVIORALCommunity-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.
BEHAVIORALstandard of care
Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.
Sponsors
Seoul National University Hospital
University of Seoul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Quality of Life Inventory (PedsQL) Total Score | Baseline (Week 0), 12 weeks, 24 weeks | 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). |
| Cardiac Rehabilitation Program Attendance Rate | 12 weeks, 24 weeks | Calculated as the number of participated sessions divided by the total number of provided sessions (%). |
| Drop-out Rate | 12 weeks, 24 weeks | Percentage of participants who dropped out related to the intervention |
| Change in Physical Activity Level | Baseline, 12 weeks, 24 weeks | Measured by an accelerometer (GENEActiv) worn for 7 days and smartwatch data. |
| Change in Global Physical Activity Questionnaire (GPAQ) Score | Baseline, 12 weeks, 24 weeks | 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). |
| Change in Pediatric Quality of Life Inventory (PedsQL) Parent Proxy-Report Score | Baseline, 12 weeks, 24 weeks | 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). |
| Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score | Baseline, 12 weeks, 24 weeks | 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). |
| Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Parent Proxy-Report Score | Baseline, 12 weeks, 24 weeks | 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). |
| Change in Resilience Scale for Youth (RS-Y) Score | Baseline, 12 weeks, 24 weeks | 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). |
| Change in Child Behavior Checklist (CBCL) Score | Baseline, 12 weeks, 24 weeks | 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). |
| Change in Korean Children's Depression Inventory 2: Self-Report (K-CDI-2:SR) Score | Baseline, 12 weeks, 24 weeks | 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). |
| Change in Revised Children's Manifest Anxiety Scale, Second Edition (RCMAS-2) Score | Baseline, 12 weeks, 24 weeks | 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). |
| Incidence of Adverse Events (Safety) | 12 weeks, 24 weeks | Proportion and rate of adverse events and serious adverse events occurring during exercise. |
| Change in Oxygen Consumption (VO2) | Baseline, 12 weeks, 24 weeks | The volume of oxygen consumed per minute during the cardiopulmonary exercise test. Unit: L/min. |
| Change in Carbon Dioxide Production (VCO2) | Baseline, 12 weeks, 24 weeks | The volume of carbon dioxide produced per minute during the cardiopulmonary exercise test. Unit: L/min. |
| Change in Respiratory Exchange Ratio (RER) | Baseline, 12 weeks, 24 weeks | The ratio of carbon dioxide production to oxygen consumption during the cardiopulmonary exercise test. Unit: Ratio |
| Change in Minute Ventilation (VE) | Baseline, 12 weeks, 24 weeks | The total volume of air inhaled and exhaled per minute during the cardiopulmonary exercise test. Unit: L/min. |
| Change in Ventilatory Equivalent for Oxygen (VE/VO2) | Baseline, 12 weeks, 24 weeks | The ratio of minute ventilation to oxygen consumption, reflecting ventilatory efficiency. Unit: Ratio |
| Change in Ventilatory Equivalent for Carbon Dioxide (VE/VCO2) | Baseline, 12 weeks, 24 weeks | The ratio of minute ventilation to carbon dioxide production, reflecting ventilatory efficiency. Unit: Ratio |
| Change in Oxygen Pulse (O2 Pulse) | Baseline, 12 weeks, 24 weeks | The amount of oxygen consumed per heart beat during the cardiopulmonary exercise test. Unit: mL/beat. |
| Change in Peripheral Capillary Oxygen Saturation (SpO2) | Baseline, 12 weeks, 24 weeks | The blood oxygen saturation level measured via pulse oximetry during the cardiopulmonary exercise test. Unit: %. |
| Change in Maximal Heart Rate (HRmax) | Baseline, 12 weeks, 24 weeks | The highest heart rate achieved during the cardiopulmonary exercise test. Unit: beats per minute (bpm). |
| Change in Skeletal Muscle Mass measured by Bioelectrical Impedance Analysis (BIA) | Baseline, 12 weeks, 24 weeks | The total weight of skeletal muscle in the body measured by bioelectrical impedance analysis. Unit: kg. |
| Change in Fat Mass measured by Bioelectrical Impedance Analysis (BIA) | Baseline, 12 weeks, 24 weeks | The total weight of fat in the body measured by bioelectrical impedance analysis. Unit: kg. |
| Change in Percent Body Fat measured by Bioelectrical Impedance Analysis (BIA) | Baseline, 12 weeks, 24 weeks 13. | The percentage of total body weight that consists of fat, measured by bioelectrical impedance analysis. Unit: %. |
| Change in Abdominal Fat Ratio measured by Bioelectrical Impedance Analysis (BIA) | Baseline, 12 weeks, 24 weeks | The ratio of abdominal fat, evaluated by waist-to-hip circumference ratio via bioelectrical impedance analysis. Unit: %. |
| Change in Extracellular Water Ratio measured by Bioelectrical Impedance Analysis (BIA) | Baseline, 12 weeks, 24 weeks | The ratio of extracellular water to total body water, measured by bioelectrical impedance analysis. Unit: %. |
| Change in Radial Artery Augmentation Index (AIx) | Baseline, 12 weeks, 24 weeks | A measure of arterial stiffness derived from the radial artery pulse wave, standardized to a heart rate of 75 bpm (AIx@75). Unit: %. |
| Change in Carotid-femoral Pulse Wave Velocity (c-f PWV) | Baseline, 12 weeks, 24 weeks | The speed of the arterial pulse propagating from the carotid to the femoral artery, reflecting arterial stiffness. Unit: m/s. |
| Change in Flow-Mediated Dilation (FMD) | Baseline, 12 weeks, 24 weeks | The percentage increase in brachial artery diameter following a period of ischemia, assessing endothelial function. Unit: %. |
| Change in 6-Minute Walk Test (6MWT) Distance | Baseline, 12 weeks, 24 weeks | The total distance a participant can walk on a flat, hard surface in exactly 6 minutes. Unit: meters (m). |
| Change in Lower Limb Strength measured by isokinetic dynamometer (Biodex) | Baseline, 12 weeks, 24 weeks | The maximum isometric knee extension peak torque measured by an isokinetic dynamometer. Unit: Newton meters (N.m). |
| Change in Lower Limb Muscular Endurance measured by 1-minute squats | Baseline, 12 weeks, 24 weeks | The total number of chair stand squats completed within exactly one minute. Unit: repetitions. |
| Change in Upper Limb Strength (Grip Strength) | Baseline, 12 weeks, 24 weeks | The maximum isometric handgrip strength measured using a hand dynamometer. Unit: kg. |
| Change in Flexibility measured by sit and reach test | Baseline, 12 weeks, 24 weeks | The maximum distance reached forward while sitting with legs extended, assessing lower back and hamstring flexibility. Unit: cm. |
| Change in Maximal Inspiratory Pressure (MIP) | Baseline, 12 weeks, 24 weeks | The maximum pressure generated during inspiration against an occluded airway, assessing respiratory muscle strength. Unit: mmH2O. |
Countries
South Korea
Contacts
CONTACTSungbae Jo Research Professor, Ph.D
Outcome results
None listed