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| Name | Class |
|---|---|
| University of Seoul | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sungbae Jo Research Professor, Ph.D | Contact | 82-2-2072-4178 | sungbaejo@snuh.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| standard of care | Behavioral | Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention. |
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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 |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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