The Respiratory Physiology Variation of COPD Patients in Inspiratory Muscle Training
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Threshold IMT®
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Respiratory muscle training device
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Inspiratory muscle training group
control group
Arm Description
COPD patient use Inspiratory muscle trainer (Threshold IMT®)
normal volunteers use Inspiratory muscle trainer(Threshold IMT®)
Outcomes
Primary Outcome Measures
Transdiaphragmatic pressure
measure the transdiaphragmatic pressure while spontaneous breathing
Secondary Outcome Measures
Full Information
NCT ID
NCT02278523
First Posted
October 15, 2014
Last Updated
October 28, 2014
Sponsor
Guangzhou Institute of Respiratory Disease
1. Study Identification
Unique Protocol Identification Number
NCT02278523
Brief Title
The Respiratory Physiology Variation of COPD Patients in Inspiratory Muscle Training
Official Title
The Respiratory Physiology Variation of COPD Patients in Inspiratory Muscle Training
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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 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.
Experimental methods : prospective randomized controlled trial(RCT)
record the information of the subjects: sexuality, age ( years ), height ( cm), weight ( kg ), BMI ;
Pulmonary function tests:forced expiratory volume in 1 second(FEV1), FEV1 of the predicted value (FEV1/Pred%), forced vital capacity (FVC), FVC of the predicted value (FVC/Pred%), a ratio of FEV1 to forced vital capacity (FEV1/FVC%).
Synchronous record:mouth 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 )).
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 30%,40%,50%,60%,70%,80% of the MIP respectively. The change from baseline in transdiaphragmatic pressure will be detect in each level of load.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory muscle training group
Arm Type
Experimental
Arm Description
COPD patient use Inspiratory muscle trainer (Threshold IMT®)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
normal volunteers use Inspiratory muscle trainer(Threshold IMT®)
Intervention Type
Device
Intervention Name(s)
Threshold IMT®
Other Intervention Name(s)
threshold inspiratory muscle trainer
Intervention Description
A device used to offer threshold load to inspiratory muscle
Primary Outcome Measure Information:
Title
Transdiaphragmatic pressure
Description
measure the transdiaphragmatic pressure while spontaneous breathing
Time Frame
half an hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Rongchang, Master
Organizational Affiliation
Guangzhou Institude of Respiratory Disease
Official's Role
Study Chair
Facility Information:
Facility Name
Respiratory muscle training device
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Respiratory Physiology Variation of COPD Patients in Inspiratory Muscle Training
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