<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/NCT02186340</url>
  </required_header>
  <id_info>
    <org_study_id>S52852-2</org_study_id>
    <nct_id>NCT02186340</nct_id>
  </id_info>
  <brief_title>Effects of Inspiratory Muscle Training on Breathing Pattern in Patients With Chronic Obstructive Pulmonary Disease</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <brief_summary>
    <textblock>
      The improvement in inspiratory muscle function might result in beneficial changes in&#xD;
      breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory&#xD;
      muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing&#xD;
      pattern during an incremental cycle exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in breathing pattern during an incremental cycle exercise test</measure>
    <time_frame>Baseline and 8 weeks follow-up</time_frame>
    <description>At comparable levels of ventilation breathing frequency, inspiratory time (Ti), expiratory time (Te), total time of the respiratory cycle (Ttot), inspiratory duty cycle (Ti/Ttot), and inspiratory flow rates will be compared.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Muscle Weakness Conditions</condition>
  <arm_group>
    <arm_group_label>Inspiratory muscle training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Inspiratory muscle training</intervention_name>
    <arm_group_label>Inspiratory muscle training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically stable COPD patients&#xD;
&#xD;
          -  maximal inspiratory pressure &lt;100% of the predicted normal value&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major comorbidities preventing successful participation in an 8 week exercise training&#xD;
             intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rik PT Gosselink, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>August 28, 2015</last_update_submitted>
  <last_update_submitted_qc>August 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Daniel Langer</investigator_full_name>
    <investigator_title>Dr Daniel Langer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <!-- 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/NCT02186340
org study id: S52852-2
nct id: NCT02186340
lead sponsor: 
The improvement in inspiratory muscle function might result in beneficial changes in
      breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory
      muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing
      pattern during an incremental cycle exercise.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in breathing pattern during an incremental cycle exercise test
time frame: Baseline and 8 weeks follow-up
description: At comparable levels of ventilation breathing frequency, inspiratory time (Ti), expiratory time (Te), total time of the respiratory cycle (Ttot), inspiratory duty cycle (Ti/Ttot), and inspiratory flow rates will be compared.
arm group label: Inspiratory muscle training
arm group type: Experimental
intervention type: Procedure
intervention name: Inspiratory muscle training
arm group label: Inspiratory muscle training
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Rik PT Gosselink, PhD
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Daniel Langer
investigator title: Dr Daniel Langer
mesh term: Muscle Weakness
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive