Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD
2017年4月24日 更新者：Diogo Fanfa Bordin、University of Santa Cruz do Sul
Effects of Inspiratory Muscle Training on Respiratory Electromyographic Activity in Patients With COPD Participants and Non-participants of a Pulmonary Rehabilitation Program
Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ® through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles, the chief of these being the diaphragm which is which objectified the improvement of its function . To monitor the action of the respiratory muscles can be used several tools such as manometer that aims to assess respiratory pressures, ie, the strength of respiratory muscles, or the Surface Electromyography (sEMG) that allow evaluating the electromyographic activity of muscles analyzed. From a quantitative clinical trial, randomized and blinded, composed of 45 individuals obtained by random convenience and divided into three groups, COPD participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR - Trained Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained Group not Rehabilitated) and a control group composed of healthy individuals (CG) that seek to analyze the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle strength, lung volumes and breathing patterns before and after a period of eight weeks of TMI. Manual will also be held dynamometry to compare the grip strength of the CG, TGR and TGNR only at baseline.
Hypothesis:
- The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP) in COPD patients regardless of whether they are enrolled in a program of pulmonary rehabilitation (PR).
- TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program.
- Patients with COPD who do not participate in a PR program have higher handgrip strength compared to patients who did not participate in a PR program.
- There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI.
- TMI in COPD patients participating in a program RP produces greater increase in MIP, the handgrip strength, improves breathing pattern and a greater reduction in the activity of the SCM muscle and diaphragm than in those who did not participate in a program RP.
- There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood pressure and increased oxygen saturation at the end of the TMI.
- TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.
研究概览
研究类型
介入性
注册 (实际的)
20
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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Rio Grande do Sul
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Santa Cruz do Sul、Rio Grande do Sul、巴西
- Universidade de Santa Cruz do Sul
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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
40年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Will be included in the study subjects of both sexes aged between 40 and 80 years. For the control group will participate in healthy subjects, non-smokers with normal lung function. For Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group participate COPD patients with GOLD staging II and III, participants and non-participants of a PR program respectively, where individuals not participating (GTMINR) will be those who will enter the PR program during the stipulated time of study and the participants have (GTMIR) should be included in the project for at least eight weeks, the time required for a program to provide RP's effects in COPD
Exclusion Criteria:
- Not participate in the study and Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group, individuals who do not fit the criteria for GOLD in stages II and III, which are in acute disease, presenting hemodynamic instability, aneurysm, cognitive impairment or any other co-morbidity that prevents this study. For the GC will not participate smokers, ex-smokers or who have compromised lung function, individuals participating in regular physical activity, ie three or more times per week, and no pathology that affects the cardiorespiratory system. Also excluded are those who do not sign the consent form.
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：阶乘赋值
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Group Pulmonary Rehabilitation
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard desinsuflativo (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
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Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
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实验性的：Group TMI + Pulmonary Rehabilitation
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program.
The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
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Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program.
The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
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实验性的：Control Group
Inspiratory muscle training will be held three times a week for eight weeks
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Will be held inspiratory muscle training associated with a pulmonary rehabilitation program.
The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
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实验性的：COPD group not rehabilitation
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Will be held inspiratory muscle training associated with a pulmonary rehabilitation program.
The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
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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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Muscle electromyographic activity of the accessory Inspiration
大体时间：The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
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The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
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次要结果测量
结果测量 |
大体时间 |
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Inspiratory Muscle Training
大体时间：Will be performed with frequency of three days non-consecutive week, for eight weeks
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Will be performed with frequency of three days non-consecutive week, for eight weeks
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Assessment of lung volumes
大体时间：will be performed previously to the study and at the end, over eight weeks
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will be performed previously to the study and at the end, over eight weeks
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assessment of respiratory muscle strength
大体时间：will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
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will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
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breathing pattern assessment
大体时间：will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks
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will be performed previously to the study and at the end of the same, It will be evaluated over 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。
调查人员
- 首席研究员：Dulciane N Paiva, Doctor、University of Santa Cruz do Sul
- 首席研究员：Diogo F Bordin, Academic、University of Santa Cruz do Sul
- 研究主任：Dannuey M Cardoso, Master、University of Santa Cruz do Sul
- 研究主任：Andrea LG da Silva, Doctor、University of Santa Cruz do Sul
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)
2013年8月1日
初级完成 (实际的)
2014年11月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2013年11月3日
首先提交符合 QC 标准的
2013年12月11日
首次发布 (估计)
2013年12月18日
研究记录更新
最后更新发布 (实际的)
2017年4月25日
上次提交的符合 QC 标准的更新
2017年4月24日
最后验证
2017年4月1日
更多信息
与本研究相关的术语
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.
Pulmonary Rehabilitation的临床试验
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IRCCS Eugenio Medea招聘中