<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/NCT02243527</url>
  </required_header>
  <id_info>
    <org_study_id>H14-00067</org_study_id>
    <nct_id>NCT02243527</nct_id>
  </id_info>
  <brief_title>Respiratory Muscles and Inspiratory Muscle Training</brief_title>
  <acronym>IMT</acronym>
  <official_title>Effects of Inspiratory Muscle Training on Respiratory Muscle Mechanics and Haemodynamics in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Natural Sciences and Engineering Research Council, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effects of inspiratory muscle training (IMT) remain controversial. Many studies have&#xD;
      examined the effect IMT has on exercise performance, but any changes to the body that come&#xD;
      from IMT have yet to be looked at.&#xD;
&#xD;
      This study will look at how someone breathes can change after IMT. Understanding how IMT&#xD;
      changes the body can help us use IMT in different treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diaphragm Electromyography</measure>
    <time_frame>Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training</time_frame>
    <description>Using a multipair esophageal electrode catheter we will determine any changes to the electric activity of the diaphragm.&#xD;
Diaphragm electromyography (EMG) has been expressed as %max. This unit is determined as the ratio of average EMG value (uV) divided by the maximal EMG activity (uV) generated during a maximal respiratory maneuver (inspiratory capacity during exercise).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accessory Respiratory Muscle Activation</measure>
    <time_frame>Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training</time_frame>
    <description>Using surface electromyography to determine the activation patterns of accessory respiratory muscles (scalene and sternocleidomastoid).&#xD;
Data are expressed as %max. This value is determined by taking the average electromyography (EMG) activity divided by the maximal EMG activity generated during a maximal inspiratory maneuver (inspiratory capacity during exercise).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dyspnoea</measure>
    <time_frame>Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training</time_frame>
    <description>Using the modified Borg scale to assess changes in perceived dyspnoea after inspiratory muscle training.&#xD;
The modified Borg scale is a 0-10 category ratio scale. The floor (0) of the scale is anchored subjectively to the subjects interpretation of &quot;no breathing discomfort at all&quot;, and the ceiling (10) to represent &quot;the most intense breathing discomfort they have experienced or could imagine experiencing&quot;.</description>
  </other_outcome>
  <other_outcome>
    <measure>Muscle Oxygenation</measure>
    <time_frame>Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training</time_frame>
    <description>Using near-infrared spectroscopy to examine if there are any relative changes in concentration (∆umol/Litre) of deoxygenated hemoglobin (HHb) after training. Deoxygenated hemoglobin is used as a surrogate of oxygen extraction specific to the local vasculature of the vastus lateralis,</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Respiratory Muscles</condition>
  <condition>Breathing Exercises</condition>
  <arm_group>
    <arm_group_label>Inspiratory Muscle Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham-Control Inspiratory Muscle Training</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Inspiratory muscle training at a low intensity meant to elicit no physiological changes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inspiratory Muscle Training</intervention_name>
    <description>6-weeks of inspiratory muscle training</description>
    <arm_group_label>Inspiratory Muscle Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Inspiratory Muscle Training</intervention_name>
    <description>A sham training procedure that is meant to elicit no physiologic changes</description>
    <arm_group_label>Sham-Control Inspiratory Muscle Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recreationally active, 'Moderate' or 'High' category on International Physical&#xD;
             Activity Questionnaire Short form questionnaire&#xD;
&#xD;
          -  Able to read and understand English&#xD;
&#xD;
          -  Pulmonary function within normal limits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or currently smoking&#xD;
&#xD;
          -  History or current symptoms of cardiopulmonary disease (including asthma and exercise&#xD;
             induced asthma)&#xD;
&#xD;
          -  Currently participating and training in a sport at a provincial, national, or&#xD;
             international level&#xD;
&#xD;
          -  Ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal&#xD;
             surgery&#xD;
&#xD;
          -  Allergies to latex or local anesthetic&#xD;
&#xD;
          -  Contraindications to exercise testing&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jordan A Guenette, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia/Centre for Heart Lung Innovation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Heart Lung Innovation</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <results_first_submitted>November 8, 2018</results_first_submitted>
  <results_first_submitted_qc>April 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 5, 2019</results_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Jordan Guenette</investigator_full_name>
    <investigator_title>Dr. Jordan Guenette</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Inspiratory Muscle Training</title>
          <description>Inspiratory Muscle Training: 6-weeks of inspiratory muscle training</description>
        </group>
        <group group_id="P2">
          <title>Sham-Control Inspiratory Muscle Training</title>
          <description>Inspiratory muscle training at a low intensity meant to elicit no physiological changes.&#xD;
Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Inspiratory Muscle Training</title>
          <description>Inspiratory Muscle Training: 6-weeks of inspiratory muscle training</description>
        </group>
        <group group_id="B2">
          <title>Sham-Control Inspiratory Muscle Training</title>
          <description>Inspiratory muscle training at a low intensity meant to elicit no physiological changes.&#xD;
Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="13"/>
                    <count group_id="B3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="13"/>
                    <count group_id="B3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25" spread="5"/>
                    <measurement group_id="B2" value="24" spread="4"/>
                    <measurement group_id="B3" value="24" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="13"/>
                    <count group_id="B3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="13"/>
                    <count group_id="B3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Diaphragm Electromyography</title>
        <description>Using a multipair esophageal electrode catheter we will determine any changes to the electric activity of the diaphragm.&#xD;
Diaphragm electromyography (EMG) has been expressed as %max. This unit is determined as the ratio of average EMG value (uV) divided by the maximal EMG activity (uV) generated during a maximal respiratory maneuver (inspiratory capacity during exercise).</description>
        <time_frame>Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Inspiratory Muscle Training</title>
            <description>Inspiratory Muscle Training: 6-weeks of inspiratory muscle training</description>
          </group>
          <group group_id="O2">
            <title>Sham-Control Inspiratory Muscle Training</title>
            <description>Inspiratory muscle training at a low intensity meant to elicit no physiological changes.&#xD;
Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes</description>
          </group>
        </group_list>
        <measure>
          <title>Diaphragm Electromyography</title>
          <description>Using a multipair esophageal electrode catheter we will determine any changes to the electric activity of the diaphragm.&#xD;
Diaphragm electromyography (EMG) has been expressed as %max. This unit is determined as the ratio of average EMG value (uV) divided by the maximal EMG activity (uV) generated during a maximal respiratory maneuver (inspiratory capacity during exercise).</description>
          <units>%max</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" spread="13"/>
                    <measurement group_id="O2" value="55" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accessory Respiratory Muscle Activation</title>
        <description>Using surface electromyography to determine the activation patterns of accessory respiratory muscles (scalene and sternocleidomastoid).&#xD;
Data are expressed as %max. This value is determined by taking the average electromyography (EMG) activity divided by the maximal EMG activity generated during a maximal inspiratory maneuver (inspiratory capacity during exercise).</description>
        <time_frame>Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Inspiratory Muscle Training</title>
            <description>Inspiratory Muscle Training: 6-weeks of inspiratory muscle training</description>
          </group>
          <group group_id="O2">
            <title>Sham-Control Inspiratory Muscle Training</title>
            <description>Inspiratory muscle training at a low intensity meant to elicit no physiological changes.&#xD;
Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes</description>
          </group>
        </group_list>
        <measure>
          <title>Accessory Respiratory Muscle Activation</title>
          <description>Using surface electromyography to determine the activation patterns of accessory respiratory muscles (scalene and sternocleidomastoid).&#xD;
Data are expressed as %max. This value is determined by taking the average electromyography (EMG) activity divided by the maximal EMG activity generated during a maximal inspiratory maneuver (inspiratory capacity during exercise).</description>
          <units>%max</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" spread="7"/>
                    <measurement group_id="O2" value="6" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Dyspnoea</title>
        <description>Using the modified Borg scale to assess changes in perceived dyspnoea after inspiratory muscle training.&#xD;
The modified Borg scale is a 0-10 category ratio scale. The floor (0) of the scale is anchored subjectively to the subjects interpretation of &quot;no breathing discomfort at all&quot;, and the ceiling (10) to represent &quot;the most intense breathing discomfort they have experienced or could imagine experiencing&quot;.</description>
        <time_frame>Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Inspiratory Muscle Training</title>
            <description>Inspiratory Muscle Training: 6-weeks of inspiratory muscle training</description>
          </group>
          <group group_id="O2">
            <title>Sham-Control Inspiratory Muscle Training</title>
            <description>Inspiratory muscle training at a low intensity meant to elicit no physiological changes.&#xD;
Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes</description>
          </group>
        </group_list>
        <measure>
          <title>Dyspnoea</title>
          <description>Using the modified Borg scale to assess changes in perceived dyspnoea after inspiratory muscle training.&#xD;
The modified Borg scale is a 0-10 category ratio scale. The floor (0) of the scale is anchored subjectively to the subjects interpretation of &quot;no breathing discomfort at all&quot;, and the ceiling (10) to represent &quot;the most intense breathing discomfort they have experienced or could imagine experiencing&quot;.</description>
          <units>Borg Units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="1.9"/>
                    <measurement group_id="O2" value="8.3" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Muscle Oxygenation</title>
        <description>Using near-infrared spectroscopy to examine if there are any relative changes in concentration (∆umol/Litre) of deoxygenated hemoglobin (HHb) after training. Deoxygenated hemoglobin is used as a surrogate of oxygen extraction specific to the local vasculature of the vastus lateralis,</description>
        <time_frame>Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Inspiratory Muscle Training</title>
            <description>Inspiratory Muscle Training: 6-weeks of inspiratory muscle training</description>
          </group>
          <group group_id="O2">
            <title>Sham-Control Inspiratory Muscle Training</title>
            <description>Inspiratory muscle training at a low intensity meant to elicit no physiological changes.&#xD;
Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes</description>
          </group>
        </group_list>
        <measure>
          <title>Muscle Oxygenation</title>
          <description>Using near-infrared spectroscopy to examine if there are any relative changes in concentration (∆umol/Litre) of deoxygenated hemoglobin (HHb) after training. Deoxygenated hemoglobin is used as a surrogate of oxygen extraction specific to the local vasculature of the vastus lateralis,</description>
          <units>change in umol/Litre HHb</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="9.3"/>
                    <measurement group_id="O2" value="16.1" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>No adverse events occurred.</desc>
      <group_list>
        <group group_id="E1">
          <title>Inspiratory Muscle Training</title>
          <description>Inspiratory Muscle Training: 6-weeks of inspiratory muscle training</description>
        </group>
        <group group_id="E2">
          <title>Sham-Control Inspiratory Muscle Training</title>
          <description>Inspiratory muscle training at a low intensity meant to elicit no physiological changes.&#xD;
Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jordan A. Guenette</name_or_title>
      <organization>University of British Columbia</organization>
      <phone>604.682.2344 ext 62129</phone>
      <email>Jordan.guenette@hli.ubc.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02243527
org study id: H14-00067
nct id: NCT02243527
lead sponsor: 
collaborator: 
has dmc: No
The effects of inspiratory muscle training (IMT) remain controversial. Many studies have
      examined the effect IMT has on exercise performance, but any changes to the body that come
      from IMT have yet to be looked at.

      This study will look at how someone breathes can change after IMT. Understanding how IMT
      changes the body can help us use IMT in different treatments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Diaphragm Electromyography
time frame: Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training
description: Using a multipair esophageal electrode catheter we will determine any changes to the electric activity of the diaphragm.
Diaphragm electromyography (EMG) has been expressed as %max. This unit is determined as the ratio of average EMG value (uV) divided by the maximal EMG activity (uV) generated during a maximal respiratory maneuver (inspiratory capacity during exercise).
measure: Accessory Respiratory Muscle Activation
time frame: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
description: Using surface electromyography to determine the activation patterns of accessory respiratory muscles (scalene and sternocleidomastoid).
Data are expressed as %max. This value is determined by taking the average electromyography (EMG) activity divided by the maximal EMG activity generated during a maximal inspiratory maneuver (inspiratory capacity during exercise).
measure: Dyspnoea
time frame: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
description: Using the modified Borg scale to assess changes in perceived dyspnoea after inspiratory muscle training.
The modified Borg scale is a 0-10 category ratio scale. The floor (0) of the scale is anchored subjectively to the subjects interpretation of "no breathing discomfort at all", and the ceiling (10) to represent "the most intense breathing discomfort they have experienced or could imagine experiencing".
measure: Muscle Oxygenation
time frame: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
description: Using near-infrared spectroscopy to examine if there are any relative changes in concentration (∆umol/Litre) of deoxygenated hemoglobin (HHb) after training. Deoxygenated hemoglobin is used as a surrogate of oxygen extraction specific to the local vasculature of the vastus lateralis,
arm group label: Inspiratory Muscle Training
arm group type: Experimental
arm group label: Sham-Control Inspiratory Muscle Training
arm group type: Sham Comparator
description: Inspiratory muscle training at a low intensity meant to elicit no physiological changes.
intervention type: Other
intervention name: Inspiratory Muscle Training
description: 6-weeks of inspiratory muscle training
arm group label: Inspiratory Muscle Training
intervention type: Other
intervention name: Sham Inspiratory Muscle Training
description: A sham training procedure that is meant to elicit no physiologic changes
arm group label: Sham-Control Inspiratory Muscle Training
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jordan A Guenette, PhD
role: Principal Investigator
affiliation: University of British Columbia/Centre for Heart Lung Innovation
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Jordan Guenette
investigator title: Dr. Jordan Guenette
mesh term: Respiratory Aspiration
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 