The Effectiveness of Cardiopulmonary Exercise in Children With Pectus Excavatum: A Single-Blind, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Maximal inspiration and expiration pressure
研究概览
简要总结
The aim of this study is to investigate the effects of cardiopulmonary rehabilitation on respiratory function, exercise tolerance and posture in patients with pectus excavatum.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-18 years with pectus excavatum deformity
- •Children undergoing conservative treatment (vacuum orthosis, exercise)
- •Patients whose families have signed a consent form agreeing to participate in the study
排除标准
- •Known cardiac disease
- •Presence of an additional syndrome (Marfan syndrome, etc.)
- •Cobb angle ≥10°
- •Refusal to participate in the study
- •Presence of mixed deformity (pectus arcuatum)
- •Those with an indication for surgery
研究组 & 干预措施
cardiopulmonary exercises group at hospital
The working group will be provided with a personalised exercise plan by a physiotherapist specialising in that field at the cardiopulmonary rehabilitation unit, to be carried out twice a week for five weeks. Patients will work on a bicycle ergometer. In addition, the same physiotherapist will demonstrate breathing and posture exercises for patients to perform at home.
干预措施: Cardiopulmonary exercises at hospital (Other)
pulmonary exercises group at home
The physiotherapist will only demonstrate the breathing and posture exercises that patients in the control group will perform at home.
干预措施: Pulmonary and posture exercises at home (Other)
结局指标
主要结局
Maximal inspiration and expiration pressure
时间窗: first day of exercises program and 5th week of exercises program
次要结局
- body lenght(first day of exercises program and 5th week of exercises program)
- 6 minute walking test(first day of exercises program and 5th week of exercises program)
- New York Posture Scale(first day of exercises program and 5th week of exercises program)
- Measurement of chest expansion in centimetres using a tape measure(first day of exercises program and 5th week of exercises program)
- Assessment of symptoms (exercise intolerance, psychological impact, resting dyspnoea, chest pain, spinal pain, gastrointestinal symptoms, palpitations, dyspnoea) using a visual analogue scale(first day of exercises program and 5th week of exercises program)
- Cobb angle analysis using the Diers Formatrix 4D device (Wiesbaden, Germany)(first day of exercises program and 5th week of exercises program)
- Thoracic kyphosis angle(first day of exercises program and 5th week of exercises program)
- Saggital balance angle using the Diers Formatrix 4D device (Wiesbaden, Germany)(first day of exercises program and 5th week of exercises program)
- Coronal balance angle using the Diers Formatrix 4D device (Wiesbaden, Germany)(first day of exercises program and 5th week of exercises program)
- pelvic obliquity angle using the Diers Formatrix 4D device (Wiesbaden, Germany)(first day of exercises program and 5th week of exercises program)
研究者
Ayse Naz Kalem
PM&R Specialist
Ankara Etlik City Hospital