Viewing Study NCT02278523



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Last Modification Date: 2024-10-26 @ 11:33 AM
Study NCT ID: NCT02278523
Status: COMPLETED
Last Update Posted: 2014-10-30
First Post: 2014-10-15

Brief Title: The Respiratory Physiology Variation of COPD Patients in Inspiratory Muscle Training
Sponsor: Guangzhou Institute of Respiratory Disease
Organization: Guangzhou Institute of Respiratory Disease

Study Overview

Official Title: The Respiratory Physiology Variation of COPD Patients in Inspiratory Muscle Training
Status: COMPLETED
Status Verified Date: 2014-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: BackgroundRespiratory muscle weakness is observed in chronic obstructive pulmonary diseaseCOPD patients and contributes to hypercapnia dyspnoea nocturnal oxygen desaturation and reduced walking distanceDuring 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 trainingIMT increases inspiratory muscle strength and endurance and decreases dyspnoeaBut the mechanism of IMT still lack of research

PurposeThe 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 COPDAnd emerging the theoretical basis of inspiratory muscle training from respiratory physiological mechanism
Detailed Description: 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 criteria1Severe and very severe COPD postbronchodilator FEV1FVC under 70 and FEV1 under 50 of the predicted value2Inspiratory muscle weaknessMaximal Inspiratory Pressure under 60cmH2Ocentimeter water column3 bronchial dilation testBDT negative4 Exclusion of other cardiopulmonary diseases

Exclusion criterion1Suffer from acute exacerbation less than 4 weeks2 Intravenous or oral corticosteroids in 4 weeks3 With other heart lung and brain disorders4 With poor compliance

Healthy volunteers group control group Inclusion criteria1 Normal lung functionFEV1FVC above 70 and FEV1 above 50 of the predicted value 2Without inspiratory muscle weaknessMaximal Inspiratory Pressure above 60cmH2O3 without nervous system and respiratory diseases

Experimental methods prospective randomized controlled trialRCT

1 record the information of the subjects sexuality age years height cm weight kg BMI
2 Pulmonary function testsforced expiratory volume in 1 secondFEV1 FEV1 of the predicted value FEV1Pred forced vital capacity FVC FVC of the predicted value FVCPred a ratio of FEV1 to forced vital capacity FEV1FVC
3 Synchronous recordmouth pressure Pm esophageal pressure Peso intragastric pressure Pgas transdiaphragmatic pressure Pdi flow flow tidal volume volume Five lead diaphragmatic electromyography of the esophagus electromyography diaphragm EMGdi1 EMGdi2 EMGdi3 EMGdi4 EMGdi5
4 Measure the maximal inspiratory pressure records of maximum transdiaphragmatic pressure and maximum diaphragmatic electromyography simultaneously

Subjects suffer from different level of threshold load generated by threshold loading device Detecting the pressure and electrical while adjust the load to 304050607080 of the MIP respectively The change from baseline in transdiaphragmatic pressure will be detect in each level of load

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
GuangzhouIRD OTHER GuangzhouIRD None