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临床试验/NCT03295201
NCT03295201已完成不适用

Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis

Marmara University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年3月5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
22
试验地点
2
主要终点
Exercise Tolerance

研究概览

简要总结

The aim of this study is to investigate the effects of postural exercise program added to pulmonary rehabilitation program on quality of life, exercise tolerance and postural stability in children with Cystic Fibrosis.

详细描述

Cystic fibrosis (CF) is an autosomal recessive, multisystem involvement disease. The most important cause of mortality in CF is pulmonary complications. Prevention of pulmonary complications is only possible with pulmonary rehabilitation. Pulmonary rehabilitation methods used in CF are called airway cleaning techniques that include postural drainage, breathing techniques and use of devices. These techniques have not been proven to be superior to each other. Active cycle of breathing techniques (ACBT) is one of the breathing techniques used to remove secretions from the lungs.

Pulmonary disease progression in CF causes postural impairment and decrease of exercise tolerance, which can reduce effectiveness of pulmonary rehabilitation. The aim of this study is to investigate the effects of postural exercise program added to pulmonary rehabilitation program on quality of life, exercise tolerance and postural stability in children with CF.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Be diagnosed with KF
  • Be able to understand commands

排除标准

  • FEV1 below than %30
  • Cor pulmonale
  • Advanced gastroesophageal reflux
  • Current hospital admission due to lung infection
  • Be diagnosed with neuromuscular disease

研究组 & 干预措施

Pulmonary rehabilitation group

Active Comparator

Active cycle of breathing techniques (ACBT)

干预措施: Active cycle of breathing techniques (ACBT) (Other)

Pulmonary rehabilitation+exercise group

Experimental

Active cycle of breathing techniques (ACBT) and postural exercise program

干预措施: Active cycle of breathing techniques (ACBT) (Other)

Pulmonary rehabilitation+exercise group

Experimental

Active cycle of breathing techniques (ACBT) and postural exercise program

干预措施: Postural Exercise (Other)

结局指标

主要结局

Exercise Tolerance

时间窗: 6 months

Modified Shuttle Test (MST) is used to measure the exercise tolerance. The patient is asked to walk until feeling tired between two fixed objects with a 10-meter interval, starting at normal walking speed and increasing the speed at the beginning of each minute. Maximum distance (meters) is measured for the test.

次要结局

  • Postural Stability(6 months)
  • Pulmonary Function(6 months)
  • Spinal Deformity- The Cobb Angle (Researcher 1)(6 months)
  • Spinal Deformity- The Modified Cobb Angle (Researcher 1)(6 months)
  • Spinal Deformity- The Modified Cobb Angle (Researcher 2)(6 months)
  • Quality of Life(6 months)
  • Spinal Deformity- The Cobb Angle (Researcher 2)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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