<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03017300</url>
  </required_header>
  <id_info>
    <org_study_id>GuangzhouInRD</org_study_id>
    <secondary_id>GuangzhouIntRD</secondary_id>
    <nct_id>NCT03017300</nct_id>
  </id_info>
  <brief_title>Transdiaphragmatic Pressure and Neural Respiratory Drive Measured During Inspiratory Muscle Training in COPD</brief_title>
  <official_title>Transdiaphragmatic Pressure and Neural Respiratory Drive Measured During Inspiratory Muscle Training in COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Institute of Respiratory Disease</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Institute of Respiratory Disease</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inspiratory muscle training（IMT）was an rehabilitation therapy for stable patients with&#xD;
      chronic obstructive pulmonary disease(COPD). However, its therapeutic effect remains&#xD;
      undefined due to unclear of diaphragmatic mobilization during IMT. Diaphragmatic mobilization&#xD;
      represented by transdiaphragmatic pressure（Pdi）and neural respiratory drive expressed as&#xD;
      corrective root-mean-square(RMS) of diaphragmatic electromyogram(EMGdi) provide vital&#xD;
      information to select the proper IMT device and loads in COPD, therefore make curative effect&#xD;
      of IMT clarity. Pdi and RMS of diaphragmatic electromyogram (RMSdi%) was respectively&#xD;
      measured and compared during inspiratory resistive training and threshold load training in&#xD;
      stable patients of COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects：The diagnosis and severity of all participants were measured using the pulmonary&#xD;
      function test according to Global Initiative for Chronic Obstructive Lung Disease.&#xD;
&#xD;
      Inclusion criteria: (1)Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and&#xD;
      FEV1 under 50% of the predicted value (GOLD C and D group); (2)Inspiratory muscle&#xD;
      weakness（Maximal Inspiratory Pressure under 60cmH2O）; (3) Bronchial dilation test (BDT)&#xD;
      negative.&#xD;
&#xD;
      Exclusion criteria: (1) acute exacerbation in the previous 4 weeks; (2) using the oral&#xD;
      corticosteroids within4 weeks; (3) history of other respiratory, cardiovascular,&#xD;
      neuromuscular, musculoskeletal diseases that could interfere the study.&#xD;
&#xD;
      Study design This was a single-centre, cross-sectional study.&#xD;
&#xD;
      Intervention： Inspiratory resistive training All participants conducted inspiratory resistive&#xD;
      training using inspiratory resistive trainer (PFLEX, Respironics Inc, USA). Pdi and EMGdi&#xD;
      were recorded synchronously.Inspiratory resistive load was change from low intensity into&#xD;
      moderate and high intensity randomly（inspiratory hole diameters was set to 5.3mm, 2.4mm and&#xD;
      1.8mm,respectively）&#xD;
&#xD;
      Inspiratory threshold load training Inspiratory threshold load training was conducted by all&#xD;
      participants using the inspiratory threshold load trainer (Threshold Inspiration Muscle&#xD;
      Trainer, Respironics Inc, USA) .Inspiratory threshold pressure was set to low, medium and&#xD;
      high intensity randomly（threshold pressure was 30%,60% and 80% of MIP, respectively).&#xD;
&#xD;
      Measurements ：transdiaphragmatic pressure and neural respiratory drive&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>transdiaphragmatic pressure</measure>
    <time_frame>half an hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>neural respiratory drive</measure>
    <time_frame>half an hour</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>COPD（threshold IMT training）</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COPD patient use Inspiratory muscle trainer (Threshold IMT®)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD（resisive training）</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COPD patient use Inspiratory muscle trainer (PFLEX®)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Threshold IMT®</intervention_name>
    <description>A device used to offer threshold load to inspiratory muscle</description>
    <arm_group_label>COPD（threshold IMT training）</arm_group_label>
    <other_name>inspiratory threshold load inspiratory muscle training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PFLEX®</intervention_name>
    <description>A device used to offer resisive to inspiratory muscle</description>
    <arm_group_label>COPD（resisive training）</arm_group_label>
    <other_name>inspiratory resisive inspiratory muscle training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and FEV1 under 50%&#xD;
             of the predicted value (GOLD C and D group);&#xD;
&#xD;
          2. Inspiratory muscle weakness（Maximal Inspiratory Pressure under 60cmH2O）;&#xD;
&#xD;
          3. Bronchial dilation test (BDT) negative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. acute exacerbation in the previous 4 weeks;&#xD;
&#xD;
          2. using the oral corticosteroids within 4 weeks;&#xD;
&#xD;
          3. history of other respiratory, cardiovascular, neuromuscular, musculoskeletal diseases&#xD;
             that could interfere the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rongchang Chen, Master</last_name>
    <role>Study Chair</role>
    <affiliation>Guangzhou Institude of Respiratory Disease</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Institute of Respiratory Disease</investigator_affiliation>
    <investigator_full_name>Weiliang Wu</investigator_full_name>
    <investigator_title>PHD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03017300
org study id: GuangzhouInRD
secondary id: GuangzhouIntRD
nct id: NCT03017300
lead sponsor: 
has dmc: Yes
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: transdiaphragmatic pressure
time frame: half an hour
measure: neural respiratory drive
time frame: half an hour
arm group label: COPD（threshold IMT training）
arm group type: Experimental
description: COPD patient use Inspiratory muscle trainer (Threshold IMT®)
arm group label: COPD（resisive training）
arm group type: Experimental
description: COPD patient use Inspiratory muscle trainer (PFLEX®)
intervention type: Device
intervention name: Threshold IMT®
description: A device used to offer threshold load to inspiratory muscle
arm group label: COPD（threshold IMT training）
other name: inspiratory threshold load inspiratory muscle training
intervention type: Device
intervention name: PFLEX®
description: A device used to offer resisive to inspiratory muscle
arm group label: COPD（resisive training）
other name: inspiratory resisive inspiratory muscle training
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rongchang Chen, Master
role: Study Chair
affiliation: Guangzhou Institude of Respiratory Disease
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Institute of Respiratory Disease
investigator full name: Weiliang Wu
investigator title: PHD
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Undecided