NCT07572435招募中不适用
Preliminary Efficacy of a Community-Based Remote Cardiac Rehabilitation Program on Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease: A Single Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the preliminary efficacy of a 12-week community-based remote cardiac rehabilitation program on cardiopulmonary function and quality of life in pediatric patients (aged 8 to 18 years) with complex congenital heart disease. Participants will be randomly assigned to either an experimental group receiving the remote cardiac rehabilitation program or a control group receiving the standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 8 to 18 years.
- •Diagnosed with complex congenital heart disease (e.g., single ventricle, transposition of the great arteries) and have a history of cardiac surgery.
- •At least 3 months post-cardiac surgery and maintaining a stable hemodynamic status.
- •Capable of utilizing remote programs (mobile apps, video platforms, etc.) in the home environment with technical support from guardians.
- •Participant or guardian has agreed to participate and signed the written informed consent form.
- •Confirmed to have decreased physical activity level and physical well-being through assessments (Must meet both):
- •KIDSCREEN-27 Parent Proxy-report 'Physical well-being' domain T-score of 40 or below.
- •Exercise Vital Sign (EVS) survey indicating moderate-to-vigorous physical activity (MVPA) time of less than 420 minutes per week.
排除标准
- •Ongoing cardiovascular diseases such as uncontrolled arrhythmia, acute heart failure, myocarditis, or pericarditis.
- •Neurological or musculoskeletal disorders that make independent exercise impossible.
- •Cognitive impairment that prevents understanding or following the instructions of the remote rehabilitation program.
- •Clinical levels of depression or anxiety restricting exercise participation, as determined by the attending physician (assessed via Korean Children's Depression Inventory 2: Self-Report [K-CDI-2:SR] and Revised Children's Manifest Anxiety Scale, Second Edition [RCMAS-2]).
- •Inability to cooperate with study tests, such as the Cardiopulmonary Exercise Test (CPET), Electrocardiogram (ECG), and 6-Minute Walk Test (6MWT).
- •Currently wearing an artificial pacemaker.
研究者
Sung Eun Hyun
Associate Professor
Seoul National University Hospital
研究点 (1)
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