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临床试验/NCT04038892
NCT04038892已完成不适用

The Effect of Different Virtual Reality-Based Exercise Trainings on Pulmonary Function, Respiratory and Peripheral Muscle Strength, Functional Capacity and Balance in Children With Bronchiectasis

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Respiratory Function Test

研究概览

简要总结

Bronchiectasis is defined as abnormal, chronic and permanent enlargement of one or more bronchi. Disease symptoms; often productive cough, dyspnea, fatigue and wheezing. Changing pulmonary mechanics, inadequate gas exchange, decreased muscle mass and associated psychological problems may cause dyspnea, decreased exercise capacity and health-related quality of life. Exercise training as a part of pulmonary rehabilitation is used to reduce the severity of symptoms; is an effective treatment to improve exercise capacity and health status. Virtual reality based exercise training has taken its place in many areas of rehabilitation as a current and new approach. In the studies in the literature, Nintendo Wii Fit games are an effective, motivating, entertaining and clinically useful method for reducing symptoms in the rehabilitation of chronic lung diseases. Wii Fit games generally include strengthening, aerobics and balance exercises. Developed by BreathingLabs, Breathing Games, which is based on breathing exercises, are a new product, a virtual reality application that has been included in a limited number of studies, has shown its effect on reducing respiratory problems and is open to research effects for many patient groups. The importance of this study is that it will be the first study on Nintendo Wii Fit games based exercise training and Breathing Games based breathing exercises training in children with bronchiectasis.

The aim of this study is to investigate the effect of different virtual reality-based exercise trainings on pulmonary function, respiratory and peripheral muscle strength, functional capacity and balance in children with bronchiectasis.

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
Double (Participant, 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

  • •Bronchiectasis diagnosis
  • •Stable clinical condition (no exacerbation in last 4 weeks)

排除标准

  • •Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
  • •Subjects previously involved in exercise training or physiotherapy programs
  • •Previous history of lung or liver transplantation

研究组 & 干预措施

Control Group

Active Comparator

Patients in this group will receive conventional chest physiotherapy, two times a day, 7 days a week for 8 weeks. After the training given by the physiotherapist, all exercise sessions will be performed at home.

干预措施: Conventional Chest Physiotherapy (Other)

Nintendo Wii Fit Training Group

Experimental

In addition to conventional chest physiotherapy programme, patients in this group will also receive Nintendo Wii Fit based exercise training for 40 minutes, 2 times in a week for 8 weeks. All exercise sessions will be supervised by physiotherapist in a clinic per week.

干预措施: Conventional Chest Physiotherapy (Other)

Nintendo Wii Fit Training Group

Experimental

In addition to conventional chest physiotherapy programme, patients in this group will also receive Nintendo Wii Fit based exercise training for 40 minutes, 2 times in a week for 8 weeks. All exercise sessions will be supervised by physiotherapist in a clinic per week.

干预措施: Nintendo Wii Fit Based Exercise Training (Other)

BreathingLabs Breathing Games Training Group

Experimental

In addition to conventional chest physiotherapy programme, patients in this group will also receive BreathingLabs Breathing Games based exercise training for 40 minutes, 2 times in a week for 8 weeks. All exercise sessions will be supervised by physiotherapist in a clinic per week.

干预措施: Conventional Chest Physiotherapy (Other)

BreathingLabs Breathing Games Training Group

Experimental

In addition to conventional chest physiotherapy programme, patients in this group will also receive BreathingLabs Breathing Games based exercise training for 40 minutes, 2 times in a week for 8 weeks. All exercise sessions will be supervised by physiotherapist in a clinic per week.

干预措施: BreathingLabs Breathing Games Based Exercise Training (Other)

结局指标

主要结局

Respiratory Function Test

时间窗: Eight weeks

Change from baseline Forced Vital Capacity (FVC) at 8 weeks

Respiratory Muscle Strength

时间窗: Eight weeks

Change from baseline maximum inspiratory pressure (MIP) at 8 weeks

Balance

时间窗: Eight weeks

Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks

Peripheral Muscle Strength

时间窗: Eight weeks

Change from baseline M. Quadriceps strength at 8 weeks

Functional Capacity

时间窗: Eight weeks

Change from baseline distance covered in six-minute walk test at 8 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hikmet Uçgun

Research Assistant, PT, PhD (c)

Bezmialem Vakif University

研究点 (1)

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