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临床试验/NCT03017300
NCT03017300已完成不适用

Transdiaphragmatic Pressure and Neural Respiratory Drive Measured During Inspiratory Muscle Training in COPD

Guangzhou Institute of Respiratory Disease0 个研究点目标入组 12 人开始时间: 2016年1月1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
发起方
入组人数
12
主要终点
transdiaphragmatic pressure

研究概览

简要总结

Inspiratory muscle training(IMT)was an rehabilitation therapy for stable patients with chronic obstructive pulmonary disease(COPD). However, its therapeutic effect remains undefined due to unclear of diaphragmatic mobilization during IMT. Diaphragmatic mobilization represented by transdiaphragmatic pressure(Pdi)and neural respiratory drive expressed as corrective root-mean-square(RMS) of diaphragmatic electromyogram(EMGdi) provide vital information to select the proper IMT device and loads in COPD, therefore make curative effect of IMT clarity. Pdi and RMS of diaphragmatic electromyogram (RMSdi%) was respectively measured and compared during inspiratory resistive training and threshold load training in stable patients of COPD.

详细描述

Subjects:The diagnosis and severity of all participants were measured using the pulmonary function test according to Global Initiative for Chronic Obstructive Lung Disease.

Inclusion criteria: (1)Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and FEV1 under 50% of the predicted value (GOLD C and D group); (2)Inspiratory muscle weakness(Maximal Inspiratory Pressure under 60cmH2O); (3) Bronchial dilation test (BDT) negative.

Exclusion criteria: (1) acute exacerbation in the previous 4 weeks; (2) using the oral corticosteroids within4 weeks; (3) history of other respiratory, cardiovascular, neuromuscular, musculoskeletal diseases that could interfere the study.

Study design This was a single-centre, cross-sectional study.

Intervention: Inspiratory resistive training All participants conducted inspiratory resistive training using inspiratory resistive trainer (PFLEX, Respironics Inc, USA). Pdi and EMGdi were recorded synchronously.Inspiratory resistive load was change from low intensity into moderate and high intensity randomly(inspiratory hole diameters was set to 5.3mm, 2.4mm and 1.8mm,respectively)

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
Single (Investigator)

入排标准

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

入选标准

  • •Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and FEV1 under 50% of the predicted value (GOLD C and D group);
  • •Inspiratory muscle weakness(Maximal Inspiratory Pressure under 60cmH2O);
  • •Bronchial dilation test (BDT) negative

排除标准

  • •acute exacerbation in the previous 4 weeks;
  • •using the oral corticosteroids within 4 weeks;
  • •history of other respiratory, cardiovascular, neuromuscular, musculoskeletal diseases that could interfere the study.

研究组 & 干预措施

COPD(threshold IMT training)

Experimental

COPD patient use Inspiratory muscle trainer (Threshold IMT®)

干预措施: Threshold IMT® (Device)

COPD(resisive training)

Experimental

COPD patient use Inspiratory muscle trainer (PFLEX®)

干预措施: PFLEX® (Device)

结局指标

主要结局

transdiaphragmatic pressure

时间窗: half an hour

次要结局

  • neural respiratory drive(half an hour)

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

PHD

Guangzhou Institute of Respiratory Disease

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