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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
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    January 9, 2017
    Last Updated
    January 10, 2017
    Sponsor
    Guangzhou Institute of Respiratory Disease
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    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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