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临床试验/NCT02278523
NCT02278523已完成2 期

The Respiratory Physiology Variation of COPD Patients in Inspiratory Muscle Training

Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Transdiaphragmatic pressure

研究概览

简要总结

Background:Respiratory muscle weakness is observed in chronic obstructive pulmonary disease(COPD) patients and contributes to hypercapnia, dyspnoea, nocturnal oxygen desaturation and reduced walking distance.During exercise it has been shown that diaphragm work is increased in COPD and COPD patients use a larger proportion of the maximal inspiratory pressure (MIP) than healthy subjects. This pattern of breathing is closely related to the dyspnoea sensation during exercise and might potentially induce respiratory muscle fatigue. Inspiratory muscle training(IMT) increases inspiratory muscle strength and endurance, and decreases dyspnoea.But the mechanism of IMT still lack of research.

Purpose:The experiment is aim to compare of the similarities and differences of transdiaphragmatic pressure by detecting the transdiaphragmatic pressure of COPD patients and healthy volunteers in different intensity of threshold load conditions. Thus investigate how inspiratory muscle training works or mechanism in lung rehabilitation programmes of COPD.And emerging the theoretical basis of inspiratory muscle training from respiratory physiological mechanism.

详细描述

Subjects:

COPD group ( experimental group ) Ten subjects with moderate COPD were will be recruited from the investigators outpatient clinic for the study. According to the criteria of the American Thoracic Society (ATS), COPD is defined as postbronchodilator forced expiratory volume in 1 second (FEV1) of 30% to 79% of the predicted value and a ratio of FEV1 to forced vital capacity (FVC) ,70%.

Inclusion criteria:(1)Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and FEV1 under 50% of the predicted value;(2)Inspiratory muscle weakness(Maximal Inspiratory Pressure under 60cmH2O(centimeter water column).(3) bronchial dilation test(BDT) negative.(4) Exclusion of other cardiopulmonary diseases.

Exclusion criterion:(1)Suffer from acute exacerbation less than 4 weeks.(2) Intravenous or oral corticosteroids in 4 weeks.(3) With other heart, lung and brain disorders.(4) With poor compliance.

Healthy volunteers group (control group ) Inclusion criteria:(1) Normal lung function(FEV1/FVC above 70% and FEV1 above 50% of the predicted value); (2)Without inspiratory muscle weakness(Maximal Inspiratory Pressure above 60cmH2O)(3) without nervous system and respiratory diseases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and FEV1 under 50% of the predicted value
  • Inspiratory muscle weakness(Maximal Inspiratory Pressure under 60cmH2O.
  • Bronchial dilation test(BDT) negative.
  • Exclusion of other cardiopulmonary diseases.

排除标准

  • Suffer from acute exacerbation less than 4 weeks.
  • Intravenous or oral corticosteroids in 4 weeks.
  • With other heart, lung and brain disorders.
  • With poor compliance.

结局指标

主要结局

Transdiaphragmatic pressure

时间窗: half an hour

measure the transdiaphragmatic pressure while spontaneous breathing

次要结局

未报告次要终点

研究者

发起方
Guangzhou Institute of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weiliang Wu

Guangzhou Institute of Respiratory Disease

Guangzhou Institute of Respiratory Disease

研究点 (1)

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