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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Community-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 part
• Другое Home-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 progr

Первичные конечные точки

• Drop-out rate [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• Attendance rate [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]

Вторичные конечные точки (12)

• oxygen consumption, VO2 [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• maximal oxygen consumption, VO2 max [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• Respiratory exchange rate, RER [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• minute ventilation (VE) [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• ventilation effectiveness, VE/VO2 [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• oxygen per pulse, O2 pulse [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• oxygen saturation, SpO2 [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• maximal heart rate during exercise, HR max [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• heart rate by exercise intensity [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• average number of steps for 7 days using smartwatch [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• average moderate-vigorous physical activity time for 7days using smartwatch, minutes [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]
• skeletal muscle mass (kg) [Срок оценки: baseline, 12 weeks after, 24 weeks after follow-up]

Критерии участия

Критерии включения

• Aged between 8 and 18 years
• Diagnosed with complex congenital heart disease (Complex CHD) and have undergone surgery
• At least 3 months post-cardiac surgery with a stable hemodynamic status
• Capable of using remote programs (e.g., mobile apps, video-conferencing platforms) at home, with technical support from a caregiver
• Either the participant or their caregiver agrees to study participation and has signed the informed consent form

Критерии исключения

• Patients with uncontrolled arrhythmias, acute heart failure, myocarditis, pericarditis, or other ongoing cardiovascular conditions.
• Patients who are unable to exercise independently due to neurological or musculoskeletal disorders.
• Patients who cannot understand or carry out remote rehabilitation program instructions due to cognitive impairment.
• Patients showing clinically significant levels of depression or anxiety on the CDI-2 or RCMAS.
• Patients who cannot cooperate with required study assessments (e.g., CPET, ECG, 6MWT).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT06912412 · FP-2024-00016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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