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

Seoul National University

Status: Not yet enrolling

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

Treatments: Other: Community-based supervised remote cardiac rehabilitation; Other: Home-based cardiac rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT06912412

FP-2024-00016

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Community-based remote cardiac rehabilitation group

Experimental group

Description:

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

Treatment:

Other: Home-based cardiac rehabilitation program

Other: Community-based supervised remote cardiac rehabilitation