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| Name | Class |
|---|---|
| University of Seoul | OTHER |
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This study is to develop a 12-week community-based remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease and to assess its validity and safety.
For these children, a multidisciplinary approach including pediatric rehabilitation medicine, pediatric thoracic surgery, pediatrics, pediatric psychiatry, sports science, and nutrition is essential, but such comprehensive services are rarely available in Korea. As a result, pediatric cardiac rehabilitation at the community level is nearly nonexistent. Recent long-term retrospective cohort studies suggest that maintaining regular physical activity and aerobic capacity from early childhood significantly reduces future cardiovascular complications, emphasizing the importance of early pediatric cardiac rehabilitation. However, participation in existing programs is low due to limited accessibility.
The investigators hypothesize that a community-based remote cardiac rehabilitation program for these patients is both valid and safe. Participants will be children aged 8-18 years diagnosed with complex congenital heart disease , at least 3 months post-surgery, and stable cardiovascular status.
Interventions include supervised and self-directed cardiac rehabilitation exercises. Monitoring (heart rate, SpO2, ECG) will be performed in real-time, with non-real-time data collection of physical activity using smartwatches. The intervention lasts 12 weeks with a 12-week follow-up.
Validity measures include baseline evaluation, adherence, dropout rate, participant and parent satisfaction, and changes in cardiopulmonary exercise capacity, physical activity, body composition, fitness (6-minute walk, strength, flexibility, respiratory muscle strength), and questionnaires (physical activity, quality of life, exercise satisfaction, depression, psychological state).
Safety will be assessed by monitoring adverse events, vital signs, fatigue (Borg scale), and pain before and after exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community-based remote cardiac rehabilitation group | Experimental | The group is provided with a single session of supervised remote cardiac rehabilitation session per week, and 4 sessions of home-based rehabilitation. During the supervised remote session, the EKG signal, heart rate and SpO2 of the participants are monitored in real-time using a single lead EKG and SpO2 monitor. Their activity levels are also recorded using a smartwatch, in number of steps and minutes in moderate-vigorous physical activity time |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-based supervised remote cardiac rehabilitation | Other | Community-based supervised remote cardiac rehabilitation begins with a weekly session led by exercise specialists, who use remote-based materials to match each participant's target heart rate and rate of perceived exertion (RPE). During these sessions, participants perform aerobic, strength, and respiratory exercises using progressive overload principles, with devices such as the POWERbreathe Plus supporting individualized respiratory training. Depending on the risk classification for each participant, they will be provided with different intensity of exercises (depending on their measured HR max, HRR, and/or RPE). |
| Measure | Description | Time Frame |
|---|---|---|
| Drop-out rate | baseline, 12 weeks after, 24 weeks after follow-up | |
| Attendance rate | baseline, 12 weeks after, 24 weeks after follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| oxygen consumption, VO2 | Oxygen consumption (VO2) refers to the rate at which the body takes in and uses oxygen. | baseline, 12 weeks after, 24 weeks after follow-up |
| maximal oxygen consumption, VO2 max |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sungbae Jo Research professor, Ph. D | Contact | 82-10-9381-2299 | rew277@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| Home-based cardiac rehabilitation program | Other | Beyond the single supervised session, participants undertake four weekly home-based sessions.
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Maximal oxygen consumption (VO2 max) represents the highest rate at which an individual can take in, transport, and utilize oxygen during maximal or exhaustive exercise.
| baseline, 12 weeks after, 24 weeks after follow-up |
| Respiratory exchange rate, RER | Respiratory Exchange Ratio (RER) is the ratio of the volume of carbon dioxide produced (VCO2) to the volume of oxygen consumed (VO2) in the body. RER = VCO2 / VO2 | baseline, 12 weeks after, 24 weeks after follow-up |
| minute ventilation (VE) | minute ventilation (VE) refers to the total volume of air inhaled or exhaled by an individual per minute. VE = Tidal Volume (VT) x Respiratory Rate (RR) | baseline, 12 weeks after, 24 weeks after follow-up |
| ventilation effectiveness, VE/VO2 | Ventilation effectiveness, when expressed as the ratio of minute ventilation (VE) to oxygen consumption (VO2) (VE/VO2), represents the volume of air that needs to be breathed to consume one liter of oxygen. | baseline, 12 weeks after, 24 weeks after follow-up |
| oxygen per pulse, O2 pulse | baseline, 12 weeks after, 24 weeks after follow-up |
| oxygen saturation, SpO2 | baseline, 12 weeks after, 24 weeks after follow-up |
| maximal heart rate during exercise, HR max | baseline, 12 weeks after, 24 weeks after follow-up |
| heart rate by exercise intensity | baseline, 12 weeks after, 24 weeks after follow-up |
| average number of steps for 7 days using smartwatch | baseline, 12 weeks after, 24 weeks after follow-up |
| average moderate-vigorous physical activity time for 7days using smartwatch, minutes | baseline, 12 weeks after, 24 weeks after follow-up |
| skeletal muscle mass (kg) | baseline, 12 weeks after, 24 weeks after follow-up |
| body fat mass (kg) | baseline, 12 weeks after, 24 weeks after follow-up |
| body fat percentage | baseline, 12 weeks after, 24 weeks after follow-up |
| Abdominal fat percentage | baseline, 12 weeks after, 24 weeks after follow-up |
| Intracellular moisture, extracellular moisture | baseline, 12 weeks after, 24 weeks after follow-up |
| Radial artery pulse wave amplification index: Augmentation index (AIx@75 index) | arterial stiffness and wave reflection at a heart rate of 75 beats per minute | baseline, 12 weeks after, 24 weeks after follow-up |
| Carotid-femoral pulse wave velocity, c-f PWV | Carotid-femoral pulse wave velocity (c-f PWV) is a non-invasive medical test used to assess arterial stiffness, which is a measure of how rigid or flexible the arteries are. c-f PWV = Distance between carotid and femoral sites / Time difference between pulse wave arrival at the two sites. | baseline, 12 weeks after, 24 weeks after follow-up |
| Flow-mediated dilation, FMD% | Flow-Mediated Dilation (FMD%) is a non-invasive ultrasound technique used to assess endothelial function, which is the ability of the inner lining of arteries (the endothelium) to relax and contract properly. FMD% specifically measures the percentage change in the diameter of an artery in response to an increase in blood flow | baseline, 12 weeks after, 24 weeks after follow-up |
| 6 minutes walk test | total distance in meters | baseline, 12 weeks after, 24 weeks after follow-up |
| lower limb muscle strength test (peak torque/BW) | baseline, 12 weeks after, 24 weeks after follow-up |
| Upper extremity strength test: grip force (kg) | baseline, 12 weeks after, 24 weeks after follow-up |
| Flexibility check: Flexibility distance (cm) | baseline, 12 weeks after, 24 weeks after follow-up |
| Respiratory muscle strength test (MIP mmH2O) | Maximal Inspiratory Pressure (MIP) is a measurement in assessing the strength of inspiratory muscles. It reflects the strength of the diaphragm and other inspiratory muscles. | baseline, 12 weeks after, 24 weeks after follow-up |
| Global Physical Activity Questionnaire | The Global Physical Activity Questionnaire (GPAQ) doesn't have a fixed minimum and maximum score. A score of 0 would indicate no reported physical activity. Higher scores means a better outcome in terms of physical activity levels. | baseline, 12 weeks after, 24 weeks after follow-up |
| Pediatric Quality of Life Inventory™ (PedsQL™) for subjects and parents | Minimum Value (Total Score): 0 Maximum Value (Total Score): 100 Higher Scores Mean: A better outcome. Higher scores on the PedsQL™ indicate a better health-related quality of life, as reported by either the child/adolescent or their parent. | baseline, 12 weeks after, 24 weeks after follow-up |
| Pediatric Quality of Life Inventory Cardiac, PedsQL™ Cardiac | Minimum Value (Total Score): 0 Maximum Value (Total Score): 100 Higher Scores Mean: A better outcome. Higher scores on the PedsQL™ Cardiac module indicate a better health-related quality of life for the child with a cardiac condition. | baseline, 12 weeks after, 24 weeks after follow-up |
| Program satisfactory survey | 12 weeks |
| Resilience Scale for Youth, RS-Y | Minimum Value: 25 Maximum Value: 125 Higher Scores Mean: A better outcome. Higher scores on the Resilience Scale for Youth indicate a higher level of resilience in the individual. | baseline, 12 weeks after, 24 weeks after follow-up |
| Child Behavior Checklist for parents, CBCL | Minimum Value : 0 Maximum Value : 118 Higher Scores Mean: A worse outcome. Higher scores on the Total Problems scale of the CBCL indicate a greater number and severity of reported behavioral and emotional problems in the child. | baseline, 12 weeks after, 24 weeks after follow-up |
| blood pressure by exercise intensity | baseline, 12 weeks after, 24 weeks after follow-up |
| Children's Depression Inventory 2, K-CDI-2:SR | Minimum Value: 0 Maximum Value: 54 Higher Scores Mean: A worse outcome. Higher scores on the K-CDI-2:SR indicate higher levels of reported depressive symptoms. | baseline, 12 weeks after, 24 weeks after follow-up |
| Revised Children's Manifest Anxiety Scale 2, RCMAS-2 | Minimum Value: 0 Maximum Value: 49 Higher Scores Mean: A worse outcome. Higher scores on the RCMAS-2 indicate higher levels of reported anxiety. | baseline, 12 weeks after, 24 weeks after follow-up |
| Incidence proportion of adverse events and harm during exercise | Incidence proportion of participants with exercise-related adverse events as assessed by CTCAE v4.0 | 12 weeks after, 24 weeks after follow-up |
| Incidence rate of adverse events and harm during exercise | Incidence rate of participants with exercise-related adverse events as assessed by CTCAE v4.0 | 12 weeks after, 24 weeks after follow-up |
| Changes in pre- and post-workout heart rate | up to 12 weeks |
| Changes in pre- and post-workout oxygen saturation (SpO2) | up to 12 weeks |
| Changes in pre- and post-workout respiratory rate | up to 12 weeks |
| Rate of Perceived Exertion, Borg scale | Unabbreviated Scale Title: Rate of Perceived Exertion (RPE) Scale Minimum Value: 6 Maximum Value: 20 Higher Scores Mean: A worse outcome. Higher numbers on the Borg scale indicate a greater feeling of exertion. | up to 12 weeks |
| Upper extremity strength test: relative grip force (%) | baseline, 12 weeks after, 24 weeks after follow-up |
| lower limb muscle strength test (peak torque) | baseline, 12 weeks after, 24 weeks after follow-up |
| extracellular moisture ratio | baseline, 12 weeks after, 24 weeks after follow-up |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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