Virtual Reality-based Exercises' Effects on Pulmonary Functions, Cardiopulmonary Capacity, Functional Performance, and Quality of Life in Children With Repaired Congenital Diaphragmatic Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pulmonary function test, FEV1/FVC ratio
研究概览
简要总结
The study has been designed to investigate the effect of 12 weeks of using virtual reality based exercises on pulmonary functions, exercise capacity, functional performance, and quality of life in children with surgically-repaired congenital diaphragmatic hernia.
详细描述
Children with CDH have significant disruptions in their quality of life (QoL) due to their poor health, in this randomized controlled clinical trial, one important aspect of virtual reality is the interactivity of children and their interests in choosing the exercised game. Each child in two groups perform a specific virtual reality based respiratory exercises for 3 months.
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
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 6 and 10 years.
- •BMI was between 20 and 24 kg/m
- •surgically-repaired congenital diaphragmatic hernia.
- •respiratory distress symptoms.
- •under follow-up care in pediatric and physical therapy clinic.
排除标准
- •Children were excluded if they have growth abnormality.
- •neuromotor disorders.
- •children with cardiac problems.
- •unable to do understand all procedures.
研究组 & 干预措施
Traditional physical therapy program
For 15 minutes, each child in both groups perform the following specific respiratory exercises: resistance-based diaphragm strengthening exercises, breathing exercises.
干预措施: Traditional physical therapy program (Other)
Virtual reality-based exercises
Following a session of traditional physical therapy, the children in study group toke 30 minutes rest then they joined in a 30-minute VR exercise session using Nintendo Wii systems.
干预措施: Traditional physical therapy program (Other)
Virtual reality-based exercises
Following a session of traditional physical therapy, the children in study group toke 30 minutes rest then they joined in a 30-minute VR exercise session using Nintendo Wii systems.
干预措施: Virtual reality-based exercises (Other)
结局指标
主要结局
Pulmonary function test, FEV1/FVC ratio
时间窗: after 12 weeks
performed using a spirometer (Autospiro-507; Minato Medical Science; Osaka. Japan)., (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
Pulmonary function test, forced vital capacity
时间窗: after 12 weeks
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Pulmonary function test, forced expiratory volume in the first second
时间窗: after 12 weeks
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Exercise capacity assessment
时间窗: after 12 weeks
Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
Pulmonary function test, forced expiratory volume in the first second
时间窗: From date of randomization (first week of intervention)
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Pulmonary function test, forced vital capacity
时间窗: From date of randomization (first week of intervention)
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Pulmonary function test, FEV1/FVC ratio
时间窗: From date of randomization (first week of intervention)
performed using a spirometer (Autospiro-507; Minato Medical Science; Osaka. Japan)., (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
Exercise capacity assessment
时间窗: From date of randomization (first week of intervention)
Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
次要结局
- Functional performance assessment(after 12 weeks)
- Pediatric Quality of Life Inventory(after 12 weeks)
- Functional performance assessment(From date of randomization (first week of intervention))
- Pediatric Quality of Life Inventory(From date of randomization (first week of intervention))
研究者
Maged Basha
Assistant Professor, College of Medical Rehabilitation, Qassim University
Qassim University