Complex Congenital Heart Disease, Congenital Heart Disease (CHD), Congenital Heart Disease in Children
Conditions
Keywords
Complex congenital heart disease, remote cardiac rehabilitation, cardiac rehabilitation, children cardiac rehabilitation
Brief summary
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.
Interventions
OTHERCommunity-based supervised remote cardiac rehabilitation
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).
OTHERHome-based cardiac rehabilitation program
Beyond the single supervised session, participants undertake four weekly home-based sessions. * Low-Risk Group: Aerobic and respiratory exercises are performed four times per week, plus strength training once or twice weekly. Each 60-minute session includes a 10-minute warm-up, 40-minute main exercise, and 10-minute cool-down. Indoor sessions use remote exercise content and respiratory training devices, while outdoor activities may involve walking, jogging, cycling, or swimming. Exercises progress in duration, intensity, and resistance. * Moderate-Risk Group: Aerobic and respiratory exercises are done four times per week with an RPE of 8-13. Intensity and duration increase gradually, contingent on symptom stability and improved endurance. * High-Risk Group: Aerobic and respiratory sessions occur four times a week at an RPE of 8-10, each lasting around 30 minutes (5-minute warm-up, 20-30-minute main exercise, 5-minute cool-down).
Sponsors
University of Seoul
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 8 and 18 years 2. Diagnosed with complex congenital heart disease (Complex CHD) and have undergone surgery 3. At least 3 months post-cardiac surgery with a stable hemodynamic status 4. Capable of using remote programs (e.g., mobile apps, video-conferencing platforms) at home, with technical support from a caregiver 5. Either the participant or their caregiver agrees to study participation and has signed the informed consent form
Exclusion criteria
1. Patients with uncontrolled arrhythmias, acute heart failure, myocarditis, pericarditis, or other ongoing cardiovascular conditions. 2. Patients who are unable to exercise independently due to neurological or musculoskeletal disorders. 3. Patients who cannot understand or carry out remote rehabilitation program instructions due to cognitive impairment. 4. Patients showing clinically significant levels of depression or anxiety on the CDI-2 or RCMAS. 5. Patients who cannot cooperate with required study assessments (e.g., CPET, ECG, 6MWT).
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | baseline, 12 weeks after, 24 weeks after follow-up | arterial stiffness and wave reflection at a heart rate of 75 beats per minute |
| extracellular moisture ratio | 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 | — |
| oxygen consumption, VO2 | baseline, 12 weeks after, 24 weeks after follow-up | Oxygen consumption (VO2) refers to the rate at which the body takes in and uses oxygen. |
| maximal oxygen consumption, VO2 max | baseline, 12 weeks after, 24 weeks after follow-up | 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. |
| Respiratory exchange rate, RER | baseline, 12 weeks after, 24 weeks after follow-up | 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 |
| minute ventilation (VE) | baseline, 12 weeks after, 24 weeks after follow-up | 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) |
| ventilation effectiveness, VE/VO2 | baseline, 12 weeks after, 24 weeks after follow-up | 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. |
| 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 | — |
| 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 | — |
| Carotid-femoral pulse wave velocity, c-f PWV | baseline, 12 weeks after, 24 weeks after follow-up | 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. |
| Flow-mediated dilation, FMD% | baseline, 12 weeks after, 24 weeks after follow-up | 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 |
| 6 minutes walk test | baseline, 12 weeks after, 24 weeks after follow-up | total distance in meters |
| 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) | baseline, 12 weeks after, 24 weeks after follow-up | 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. |
| Global Physical Activity Questionnaire | baseline, 12 weeks after, 24 weeks after follow-up | 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. |
| Pediatric Quality of Life Inventory™ (PedsQL™) for subjects and parents | baseline, 12 weeks after, 24 weeks after follow-up | 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. |
| Pediatric Quality of Life Inventory Cardiac, PedsQL™ Cardiac | baseline, 12 weeks after, 24 weeks after follow-up | 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. |
| Program satisfactory survey | 12 weeks | — |
| Resilience Scale for Youth, RS-Y | baseline, 12 weeks after, 24 weeks after follow-up | 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. |
| Child Behavior Checklist for parents, CBCL | baseline, 12 weeks after, 24 weeks after follow-up | 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. |
| blood pressure by exercise intensity | baseline, 12 weeks after, 24 weeks after follow-up | — |
| Children's Depression Inventory 2, K-CDI-2:SR | baseline, 12 weeks after, 24 weeks after follow-up | 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. |
| Revised Children's Manifest Anxiety Scale 2, RCMAS-2 | baseline, 12 weeks after, 24 weeks after follow-up | Minimum Value: 0 Maximum Value: 49 Higher Scores Mean: A worse outcome. Higher scores on the RCMAS-2 indicate higher levels of reported anxiety. |
| Incidence proportion of adverse events and harm during exercise | 12 weeks after, 24 weeks after follow-up | Incidence proportion of participants with exercise-related adverse events as assessed by CTCAE v4.0 |
| Incidence rate of adverse events and harm during exercise | 12 weeks after, 24 weeks after follow-up | Incidence rate of participants with exercise-related adverse events as assessed by CTCAE v4.0 |
| 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 | — |
| body fat mass (kg) | baseline, 12 weeks after, 24 weeks after follow-up | — |
| Rate of Perceived Exertion, Borg scale | up to 12 weeks | 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. |
| 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 | — |
| Changes in pre- and post-workout respiratory rate | up to 12 weeks | — |
| body fat percentage | baseline, 12 weeks after, 24 weeks after follow-up | — |
Countries
South Korea
Contacts
Primary ContactSungbae Jo Research professor, Ph. D
Outcome results
None listed