Transdiaphragmatic Pressure and Neural Respiratory Drive Measured During Inspiratory Muscle Training in COPD
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|ClinicalTrials.gov Identifier: NCT03017300|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Device: Threshold IMT® Device: PFLEX®||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Transdiaphragmatic Pressure and Neural Respiratory Drive Measured During Inspiratory Muscle Training in COPD|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: COPD（threshold IMT training）
COPD patient use Inspiratory muscle trainer (Threshold IMT®)
Device: Threshold IMT®
A device used to offer threshold load to inspiratory muscle
Other Name: inspiratory threshold load inspiratory muscle training
Experimental: COPD（resisive training）
COPD patient use Inspiratory muscle trainer (PFLEX®)
A device used to offer resisive to inspiratory muscle
Other Name: inspiratory resisive inspiratory muscle training
- transdiaphragmatic pressure [ Time Frame: half an hour ]
- neural respiratory drive [ Time Frame: half an hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017300
|Study Chair:||Rongchang Chen, Master||Guangzhou Institude of Respiratory Disease|