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临床试验/NCT03375684
NCT03375684已完成不适用

Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis

Bezmialem Vakif University2 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2018年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks

研究概览

简要总结

It is extensively reported in the literature that patients with chronic obstructive lung disease may have impairments in balance and postural control which further increase the disease burden. Mechanisms related to these impairments include, but are not limited to increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic inflammation. Since the similar symptoms are reported for the children with cystic fibrosis, it is hypothesized that balance and postural control may also be compromised in these patients. Inspiratory muscle training (IMT) is shown to improve diaphragm strength and pulmonary function. Considering the relation between diaphragm which is one of the core muscles, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength, pulmonary function and functional capacity in these patients. Thus, the aim of this study was to investigate the effects of inspiratory muscle training and conventional chest physiotherapy on postural stability, balance, pulmonary function and functional capacity in children with cystic fibrosis.

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

入选标准

  • Cystic fibrosis 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

结局指标

主要结局

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

时间窗: Eight weeks

Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks

时间窗: Eight weeks

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

时间窗: Eight weeks

Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

时间窗: Eight weeks

Change from baseline maximum inspiratory pressure at 8 weeks

时间窗: Eight weeks

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

时间窗: Eight weeks

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

时间窗: Eight weeks

Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

时间窗: Eight weeks

Change from baseline maximum expiratory pressure at 8 weeks

时间窗: Eight weeks

次要结局

  • Change from baseline m. quadriceps strength at 8 weeks(Eight weeks)

研究者

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

Melih Zeren

Lecturer, MSc, PT

Bezmialem Vakif University

研究点 (2)

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