Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis
2018年5月22日 更新者:Melih Zeren、Bezmialem Vakif University
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.
研究概览
研究类型
介入性
注册 (实际的)
32
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Eyup
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Istanbul、Eyup、火鸡、34060
- Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Cystic fibrosis diagnosis
- Stable clinical condition (no exacerbation in last 4 weeks)
Exclusion Criteria:
- Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
- Subjects previously involved in exercise training or physiotherapy programs
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Control Group
Patients in this group will receive conventional chest physiotherapy, two times a day, 7 days a week for 8 weeks.
One exercise session will be supervised in a clinic per week, other sessions will be performed at home.
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Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques.
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实验性的:Training Group
In addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks.
One exercise session will be supervised in a clinic per week, other sessions will be performed at home.
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Threshold IMT device will be used for the training.
Training intensity will set at 30% of the maximum inspiratory pressure.
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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8 周时用力肺活量 (FVC) 相对于基线的变化
大体时间:八周
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八周
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第 8 周时第 1 秒用力呼气量 (FEV1) 相对于基线的变化
大体时间:八周
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八周
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8 周时基线峰值呼气流量 (PEF) 的变化
大体时间:八周
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八周
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8 周时六分钟步行测试覆盖的基线距离的变化
大体时间:八周
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八周
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Change from baseline maximum inspiratory pressure at 8 weeks
大体时间:Eight weeks
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Eight weeks
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Change from baseline maximum expiratory pressure at 8 weeks
大体时间:Eight weeks
|
Eight weeks
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Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
大体时间:Eight weeks
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Eight weeks
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Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
大体时间:Eight weeks
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Eight weeks
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Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks
大体时间:Eight weeks
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Eight weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change from baseline m. quadriceps strength at 8 weeks
大体时间:Eight weeks
|
Eight weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年1月2日
初级完成 (实际的)
2018年5月2日
研究完成 (实际的)
2018年5月21日
研究注册日期
首次提交
2017年12月6日
首先提交符合 QC 标准的
2017年12月12日
首次发布 (实际的)
2017年12月18日
研究记录更新
最后更新发布 (实际的)
2018年5月23日
上次提交的符合 QC 标准的更新
2018年5月22日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.