<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/NCT01727765</url>
  </required_header>
  <id_info>
    <org_study_id>IMT and Asthma</org_study_id>
    <nct_id>NCT01727765</nct_id>
  </id_info>
  <brief_title>Inspiratory Muscle Training and Asthma</brief_title>
  <official_title>Inspiratory Muscle Training as a Novel Approach in the Treatment of Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Portsmouth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health Service, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Portsmouth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study which will assess the feasibility of a follow on main study. This study&#xD;
      will examine the impact of inspiratory muscle training on quality of life, rescue drug&#xD;
      medication usage, and other markers of asthma in adult asthmatics in the UK.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal Inspiratory Mouth Pressure (MIP)</measure>
    <time_frame>pre (after the 4 week run-in) and post 6 weeks of IMT</time_frame>
    <description>MIP is a surrogate measure of inspiratory muscle strength and was measured pre and post 6 weeks of either experimental or sham inspiratory muscle trianing (IMT).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Comparator</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>inspiratory muscle training</intervention_name>
    <description>Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&amp;B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.</description>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_label>Sham Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asthma Control Questionnaire score of ≥ 1.5&#xD;
&#xD;
          -  10 mg or less of prednisolone (or equivalent) daily&#xD;
&#xD;
          -  Aged 18 to 59 years inclusive&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant heart or lung disease other than asthma including any previous history&#xD;
             of pneumothorax&#xD;
&#xD;
          -  Patients with a concomitant condition (including clinically relevant cardiovascular,&#xD;
             hepatic, neurological, endocrine, or other major systemic disease) not controlled with&#xD;
             treatment, making implementation of the protocol or interpretation of the study&#xD;
             results difficult&#xD;
&#xD;
          -  Women who are pregnant&#xD;
&#xD;
          -  Forced expiratory volume in one second of less than 50% best or predicted&#xD;
&#xD;
          -  A history of smoking 20 cigarettes a day for 20 years or more (or an equivalent&#xD;
             amount)&#xD;
&#xD;
          -  Undertaken a structured program of inspiratory muscle training within the past three&#xD;
             months&#xD;
&#xD;
          -  Currently a participant in another interventional study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Respiratory Centre, Queen Alexandra Hospital, Cosham</name>
      <address>
        <city>Portsmouth</city>
        <state>Hampshire</state>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Portsmouth</name>
      <address>
        <city>Portsmouth</city>
        <state>Hampshire</state>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <results_first_submitted>March 8, 2019</results_first_submitted>
  <results_first_submitted_qc>October 2, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 25, 2019</results_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Portsmouth</investigator_affiliation>
    <investigator_full_name>Mitch Lomax</investigator_full_name>
    <investigator_title>Senior Lecturer</investigator_title>
  </responsible_party>
  <keyword>Asthma, inspiratory muscle training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental</title>
          <description>6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength&#xD;
inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&amp;B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.</description>
        </group>
        <group group_id="P2">
          <title>Sham Comparator</title>
          <description>6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.&#xD;
inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&amp;B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </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>Experimental</title>
          <description>6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength&#xD;
inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&amp;B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.</description>
        </group>
        <group group_id="B2">
          <title>Sham Comparator</title>
          <description>6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.&#xD;
inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&amp;B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.</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="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" spread="12"/>
                    <measurement group_id="B2" value="54" spread="14"/>
                    <measurement group_id="B3" value="54" spread="12"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </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>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximal Inspiratory Mouth Pressure (MIP)</title>
        <description>MIP is a surrogate measure of inspiratory muscle strength and was measured pre and post 6 weeks of either experimental or sham inspiratory muscle trianing (IMT).</description>
        <time_frame>pre (after the 4 week run-in) and post 6 weeks of IMT</time_frame>
        <population>As this was a feasibility study, statistical analysis was not required</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental</title>
            <description>Undertook 6 weeks of real IMT</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>undertook 6 weeks of sham IMT</description>
          </group>
        </group_list>
        <measure>
          <title>Maximal Inspiratory Mouth Pressure (MIP)</title>
          <description>MIP is a surrogate measure of inspiratory muscle strength and was measured pre and post 6 weeks of either experimental or sham inspiratory muscle trianing (IMT).</description>
          <population>As this was a feasibility study, statistical analysis was not required</population>
          <units>kPa</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MIP pre training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.36" spread="2.63"/>
                    <measurement group_id="O2" value="9.37" spread="2.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MIP post training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.55" spread="2.72"/>
                    <measurement group_id="O2" value="9.21" spread="2.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks. This encompassed the 4 week run-in period, 2 weeks for testing (one week pre IMT and 1 week post IMT) and 6 weeks for IMT.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Experimental</title>
          <description>6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength&#xD;
inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&amp;B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.</description>
        </group>
        <group group_id="E2">
          <title>Sham Comparator</title>
          <description>6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.&#xD;
inspiratory muscle training: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&amp;B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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 Mitch Lomax</name_or_title>
      <organization>University of Portsmouth</organization>
      <phone>02392845297</phone>
      <email>mitch.lomax@port.ac.uk</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/NCT01727765
org study id: IMT and Asthma
nct id: NCT01727765
lead sponsor: 
collaborator: 
has dmc: No
This is a pilot study which will assess the feasibility of a follow on main study. This study
      will examine the impact of inspiratory muscle training on quality of life, rescue drug
      medication usage, and other markers of asthma in adult asthmatics in the UK.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Maximal Inspiratory Mouth Pressure (MIP)
time frame: pre (after the 4 week run-in) and post 6 weeks of IMT
description: MIP is a surrogate measure of inspiratory muscle strength and was measured pre and post 6 weeks of either experimental or sham inspiratory muscle trianing (IMT).
arm group label: Experimental
arm group type: Experimental
description: 6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength
arm group label: Sham Comparator
arm group type: Sham Comparator
description: 6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.
intervention type: Other
intervention name: inspiratory muscle training
description: Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.
arm group label: Experimental
arm group label: Sham Comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
facility: 
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Portsmouth
investigator full name: Mitch Lomax
investigator title: Senior Lecturer
mesh term: Asthma
mesh term: Respiratory Aspiration
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 