Clinical trial NCT06912412: Community-Based Remote Cardiac Rehabilitation Program for Pediatric Patients With Complex Congenital Heart Disease
Official title: Development and Validation of a Community-Based Remote Cardiac Rehabilitation Program for Improving Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease (CHD)
Complex Congenital Heart Disease
Congenital Heart Disease in Children
Keywords: Complex congenital heart disease
remote cardiac rehabilitation
cardiac rehabilitation
children cardiac rehabilitation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: University of Seoul
First posted: 2025-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Drop-out rate
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Attendance rate
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
Secondary outcomes:
measure: oxygen consumption, VO2
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: maximal oxygen consumption, VO2 max
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Respiratory exchange rate, RER
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: minute ventilation (VE)
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: ventilation effectiveness, VE/VO2
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: oxygen per pulse, O2 pulse
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: oxygen saturation, SpO2
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: maximal heart rate during exercise, HR max
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: heart rate by exercise intensity
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: average number of steps for 7 days using smartwatch
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: average moderate-vigorous physical activity time for 7days using smartwatch, minutes
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: skeletal muscle mass (kg)
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: body fat mass (kg)
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: body fat percentage
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Abdominal fat percentage
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Intracellular moisture, extracellular moisture
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Radial artery pulse wave amplification index: Augmentation index (AIx@75 index)
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Carotid-femoral pulse wave velocity, c-f PWV
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Flow-mediated dilation, FMD%
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: 6 minutes walk test
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: lower limb muscle strength test (peak torque/BW)
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Upper extremity strength test: grip force (kg)
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Flexibility check: Flexibility distance (cm)
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Respiratory muscle strength test (MIP mmH2O)
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Global Physical Activity Questionnaire
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Pediatric Quality of Life Inventory™ (PedsQL™) for subjects and parents
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Pediatric Quality of Life Inventory Cardiac, PedsQL™ Cardiac
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Program satisfactory survey
timeFrame: 12 weeks
measure: Resilience Scale for Youth, RS-Y
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Child Behavior Checklist for parents, CBCL
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: blood pressure by exercise intensity
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Children's Depression Inventory 2, K-CDI-2:SR
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Revised Children's Manifest Anxiety Scale 2, RCMAS-2
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: Incidence proportion of adverse events and harm during exercise
timeFrame: 12 weeks after, 24 weeks after follow-up
measure: Incidence rate of adverse events and harm during exercise
timeFrame: 12 weeks after, 24 weeks after follow-up
measure: Changes in pre- and post-workout heart rate
timeFrame: up to 12 weeks
measure: Changes in pre- and post-workout oxygen saturation (SpO2)
timeFrame: up to 12 weeks
measure: Changes in pre- and post-workout respiratory rate
timeFrame: up to 12 weeks
measure: Rate of Perceived Exertion, Borg scale
timeFrame: up to 12 weeks
measure: Upper extremity strength test: relative grip force (%)
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: lower limb muscle strength test (peak torque)
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
measure: extracellular moisture ratio
timeFrame: baseline, 12 weeks after, 24 weeks after follow-up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: