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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Drop-out rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Community-based remote cardiac rehabilitation group
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
干预措施: Community-based supervised remote cardiac rehabilitation (Other)
Community-based remote cardiac rehabilitation group
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
干预措施: Home-based cardiac rehabilitation program (Other)
结局指标
主要结局
Drop-out rate
时间窗: baseline, 12 weeks after, 24 weeks after follow-up
Attendance rate
时间窗: baseline, 12 weeks after, 24 weeks after follow-up
次要结局
- Changes in pre- and post-workout oxygen saturation (SpO2)(up to 12 weeks)
- 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)
- oxygen consumption, VO2(baseline, 12 weeks after, 24 weeks after follow-up)
- maximal oxygen consumption, VO2 max(baseline, 12 weeks after, 24 weeks after follow-up)
- Respiratory exchange rate, RER(baseline, 12 weeks after, 24 weeks after follow-up)
- minute ventilation (VE)(baseline, 12 weeks after, 24 weeks after follow-up)
- ventilation effectiveness, VE/VO2(baseline, 12 weeks after, 24 weeks after follow-up)
- 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)
- 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)
- Carotid-femoral pulse wave velocity, c-f PWV(baseline, 12 weeks after, 24 weeks after follow-up)
- Flow-mediated dilation, FMD%(baseline, 12 weeks after, 24 weeks after follow-up)
- 6 minutes walk test(baseline, 12 weeks after, 24 weeks after follow-up)
- 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)
- Global Physical Activity Questionnaire(baseline, 12 weeks after, 24 weeks after follow-up)
- Pediatric Quality of Life Inventory™ (PedsQL™) for subjects and parents(baseline, 12 weeks after, 24 weeks after follow-up)
- Pediatric Quality of Life Inventory Cardiac, PedsQL™ Cardiac(baseline, 12 weeks after, 24 weeks after follow-up)
- Program satisfactory survey(12 weeks)
- Resilience Scale for Youth, RS-Y(baseline, 12 weeks after, 24 weeks after follow-up)
- Child Behavior Checklist for parents, CBCL(baseline, 12 weeks after, 24 weeks after follow-up)
- 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)
- Changes in pre- and post-workout respiratory rate(up to 12 weeks)
- Revised Children's Manifest Anxiety Scale 2, RCMAS-2(baseline, 12 weeks after, 24 weeks after follow-up)
- Incidence proportion of adverse events and harm during exercise(12 weeks after, 24 weeks after follow-up)
- Incidence rate of adverse events and harm during exercise(12 weeks after, 24 weeks after follow-up)
- Changes in pre- and post-workout heart rate(up to 12 weeks)
- Rate of Perceived Exertion, Borg scale(up to 12 weeks)
- 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)
研究者
Woo Hyung Lee
Clinical associate professor
Seoul National University Hospital