Community-Based Remote Cardiac Rehabilitation Program for Pediatric Patients With Complex Congenital Heart Disease

Not Applicable

Not yet recruiting

• Conditions: Congenital Heart Disease (CHD); Complex Congenital Heart Disease; Congenital Heart Disease in Children

• Registration Number: NCT06912412
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-16
• Study First Submitted QC: 2025-03-30
• Last Update Submitted: 2025-03-30
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-05-31
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Drop-out rate	baseline, 12 weeks after, 24 weeks after follow-up
Attendance rate	baseline, 12 weeks after, 24 weeks after follow-up

Secondary Outcome Measures

Name	Time	Method
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
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)	baseline, 12 weeks after, 24 weeks after follow-up	arterial stiffness and wave reflection at a heart rate of 75 beats per minute
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
Changes in pre- and post-workout respiratory rate	up to 12 weeks
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
extracellular moisture ratio	baseline, 12 weeks after, 24 weeks after follow-up

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of