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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
Sponsor:
Information provided by (Responsible Party):
Weiliang Wu, Guangzhou Institute of Respiratory Disease

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Threshold IMT® Device: PFLEX® Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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®)
Device: PFLEX®
A device used to offer resisive to inspiratory muscle
Other Name: inspiratory resisive inspiratory muscle training




Primary Outcome Measures :
  1. transdiaphragmatic pressure [ Time Frame: half an hour ]

Secondary Outcome Measures :
  1. neural respiratory drive [ Time Frame: half an hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 within 4 weeks;
  3. history of other respiratory, cardiovascular, neuromuscular, musculoskeletal diseases that could interfere the study.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Investigators
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Study Chair: Rongchang Chen, Master Guangzhou Institude of Respiratory Disease
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Responsible Party: Weiliang Wu, PHD, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT03017300    
Other Study ID Numbers: GuangzhouInRD
GuangzhouIntRD ( Other Identifier: Guangzhou Institute of Respiratory Disease )
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases