Transdiaphragmatic Pressure and Neural Respiratory Drive Measured During Inspiratory Muscle Training in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Threshold IMT®
PFLEX®
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 (GOLD C and D group);
- Inspiratory muscle weakness(Maximal Inspiratory Pressure under 60cmH2O);
- Bronchial dilation test (BDT) negative
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
COPD(threshold IMT training)
COPD(resisive training)
Arm Description
COPD patient use Inspiratory muscle trainer (Threshold IMT®)
COPD patient use Inspiratory muscle trainer (PFLEX®)
Outcomes
Primary Outcome Measures
transdiaphragmatic pressure
Secondary Outcome Measures
neural respiratory drive
Full Information
NCT ID
NCT03017300
First Posted
January 9, 2017
Last Updated
January 10, 2017
Sponsor
Guangzhou Institute of Respiratory Disease
1. Study Identification
Unique Protocol Identification Number
NCT03017300
Brief Title
Transdiaphragmatic Pressure and Neural Respiratory Drive Measured During Inspiratory Muscle Training in COPD
Official Title
Transdiaphragmatic Pressure and Neural Respiratory Drive Measured During Inspiratory Muscle Training in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (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
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.
Detailed Description
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)
Inspiratory threshold load training Inspiratory threshold load training was conducted by all participants using the inspiratory threshold load trainer (Threshold Inspiration Muscle Trainer, Respironics Inc, USA) .Inspiratory threshold pressure was set to low, medium and high intensity randomly(threshold pressure was 30%,60% and 80% of MIP, respectively).
Measurements :transdiaphragmatic pressure and neural respiratory drive
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD(threshold IMT training)
Arm Type
Experimental
Arm Description
COPD patient use Inspiratory muscle trainer (Threshold IMT®)
Arm Title
COPD(resisive training)
Arm Type
Experimental
Arm Description
COPD patient use Inspiratory muscle trainer (PFLEX®)
Intervention Type
Device
Intervention Name(s)
Threshold IMT®
Other Intervention Name(s)
inspiratory threshold load inspiratory muscle training
Intervention Description
A device used to offer threshold load to inspiratory muscle
Intervention Type
Device
Intervention Name(s)
PFLEX®
Other Intervention Name(s)
inspiratory resisive inspiratory muscle training
Intervention Description
A device used to offer resisive to inspiratory muscle
Primary Outcome Measure Information:
Title
transdiaphragmatic pressure
Time Frame
half an hour
Secondary Outcome Measure Information:
Title
neural respiratory drive
Time Frame
half an hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongchang Chen, Master
Organizational Affiliation
Guangzhou Institude of Respiratory Disease
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Transdiaphragmatic Pressure and Neural Respiratory Drive Measured During Inspiratory Muscle Training in COPD
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