Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Recruitment rates
研究概览
简要总结
Children and adolescents with inherited cardiac arrhythmia su ch Long QT Syndrome (LQTS) have lower physical and quality of life than their healthy peers. A multi-component cardiac rehabilitation, including an exercise training program and education program, might counteract those effects.
The goal of this pilot study is to evaluate the security, feasibility, and benefits of a cardiac rehabilitation program in children with LQTS aged between 6 to 18 years old.
The main question[s] it aims to answer are:
- Is center-based cardiac rehabilitation safe and feasible for children with LQTS?
- Does a 12-week cardiac rehabilitation program improve physical fitness and quality of life?
详细描述
Physical fitness is an independent predictor of all-cause mortality and global health in the general population. Assessments of cardiorespiratory and muscle fitness in children with chronic illness are growing in interest, even in less prevalent chronic diseases. For instance, children and adolescents with Long QT Syndrome (LQTS) have lower cardiorespiratory fitness, muscle strength, and quality of life than their healthy peers.
A multi-component cardiac rehabilitation including an exercise training program and education program might counteract this lowered physical fitness.
The RYTHMO'FIT pilot study seeks to test the security, and feasibility, and to evaluate the benefits of an innovative center-based program to improve physical and mental health in children and adolescents with LQTS.
In this retrospective study, eight children had undergone a 12-week program, within each session composed by:
- A 1-hour exercise training session with a trained exercise physiologist: resistance training, aerobic training, stretching, and different activity (e.g., basketball, handball, football, hockey)
- A 30-min educational workshop with a specialist nurse (e.g., beta-blockade, sports participation, healthy behaviors).
- A 10-min medical interview with a cardiologist to have feedback from parents and patients on each session and the past 7 seven days.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Recruitment rates
时间窗: At week 12
Number of participants who completed baseline assessment compared to the number who were eligible (expressed in %).
Adherence
时间窗: At week 12
Percentage exercise sessions attained by participants compared to number of sessions proposed.
Security
时间窗: At week 12
Count and specify any cardiac events on the ECG scope during each session. Reporting of related and non-related event during the past 7 days through short questionnaire each week.
Retention rates
时间窗: At week 12
Participants who participated in the 12-week intervention and completed the follow-up assessments at the end of the program (expressed in %).
次要结局
- Change on cardiorespiratory fitness(between week 0 and week 12)
- Change on Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL)(between week 0 and week 12)
- Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)(between week 0 and week 12)
- Change on cardiological outcomes(between week 0 and week 12)
- Change on muscle architecture(between week 0 and week 12)
- Change on muscle strength(between week 0 and week 12)
- Change on Self reported total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire(between week 0 and week 12)
- Change on physical activity level(between week 0 and week 12)