<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/NCT04481074</url>
  </required_header>
  <id_info>
    <org_study_id>UFMG_IMT-ILD</org_study_id>
    <nct_id>NCT04481074</nct_id>
  </id_info>
  <brief_title>Inspiratory Muscle Training in Patients With Interstitial Lung Disease</brief_title>
  <acronym>IMT-ILD</acronym>
  <official_title>Effects of Inspiratory Muscle Training in Inspiratory Muscle Endurance, Breathlessness, Inspiratory Muscle Strength, Functional Capacity and Quality of Life in Patients With Interstitial Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Minas Gerais</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effects of inspiratory muscle training program in&#xD;
      inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional&#xD;
      capacity and quality of life in patients with interstitial lung disease. Patients are&#xD;
      evaluated before the inspiratory muscle training and after 8 weeks of training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inspiratory Muscle Training has been described as an effective intervention and contribute to&#xD;
      the improvement of inspiratory muscle function and breathlessness in patients with chronic&#xD;
      lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle&#xD;
      endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of&#xD;
      life in patients with interstitial lung disease. It is a quasi-experimental study. Patients&#xD;
      with interstitial lung disease are recruited from interstitial disease ambulatory. In each&#xD;
      session patients performs two times 30 breaths with a minute rest between them. The load is&#xD;
      set according with 50% of actual PImax, the Borg score should be between 4 and 6, otherwise&#xD;
      the load will decrease (if Borg more than 6) or increase (if Borg less than 4). New PImax is&#xD;
      measured weekly and the new load is defined following the same protocol for 8 weeks. Patients&#xD;
      are evaluated before the inspiratory muscle training and after 8 weeks of training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</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>
    <intervention_model_description>Quasi-experimental</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Inspiratory muscle endurance</measure>
    <time_frame>At baseline and after 8 weeks of training</time_frame>
    <description>Endurance time in seconds</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Breathlessness</measure>
    <time_frame>At baseline and after 8 weeks of training</time_frame>
    <description>Medical Research Council (1-5)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Inspiratory muscle strength</measure>
    <time_frame>At baseline and after 8 weeks of training</time_frame>
    <description>Maximal inspiratory pressure in cmH20</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional capacity</measure>
    <time_frame>At baseline and after 8 weeks of training</time_frame>
    <description>Maximal distance in 6 minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life</measure>
    <time_frame>At baseline and after 8 weeks of training</time_frame>
    <description>King's Brief Interstitial Lung Disease Questionnaire. It is a 15 questions questionnaire. Total score can go from 0 - 100, 100 is the better quality of life.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Interstitial Fibrosis</condition>
  <condition>Pulmonary Disease</condition>
  <condition>Interstitial Lung Disease</condition>
  <condition>Sarcoidosis</condition>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <condition>Pneumonia, Interstitial</condition>
  <arm_group>
    <arm_group_label>Inspiratory muscle training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group intervention: home-based interval inspiratory muscle training during 8 weeks, two sessions with two sets of 30 breaths with one minute rest between them. Load set is determinated weekly, aiming 50% of actual PImax and according to Borg Score.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inspiratory muscle training</intervention_name>
    <description>Inspiratory muscle training will be performed using the tapered flow-resistive loading trainer (POWERbreathe®).</description>
    <arm_group_label>Inspiratory muscle training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical and radiological diagnosis of interstitial lung disease established by a&#xD;
             pulmonologist;&#xD;
&#xD;
          -  Absence of clinical exacerbations of the disease in the four weeks prior to the&#xD;
             initial data collection;&#xD;
&#xD;
          -  Present medical research council scale more than 2;&#xD;
&#xD;
          -  Absence of a associated or self reported cardiac, orthopedic and psychiatric diseases,&#xD;
&#xD;
          -  Not participating in pulmonary rehabilitation programs;&#xD;
&#xD;
          -  Do not use supplemental oxygen therapy while resting.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Inability of the participant to understand or perform the procedures proposed during the&#xD;
        evaluations and training program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ambulatório Bias Fortes - Ambulatório de Doenças Intersticiais do Hospital das Clínicas da Universidade Federal de Minas Gerais.</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30150-260</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>31270-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
    <investigator_full_name>Veronica Franco Parreira</investigator_full_name>
    <investigator_title>Full Professor</investigator_title>
  </responsible_party>
  <keyword>Inspiratory muscle training</keyword>
  <keyword>Interstitial lung disease</keyword>
  <keyword>Inspiratory muscle endurance</keyword>
  <keyword>Breathless</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
    <mesh_term>Sarcoidosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT04481074
org study id: UFMG_IMT-ILD
nct id: NCT04481074
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the effects of inspiratory muscle training program in
      inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional
      capacity and quality of life in patients with interstitial lung disease. Patients are
      evaluated before the inspiratory muscle training and after 8 weeks of training.
Inspiratory Muscle Training has been described as an effective intervention and contribute to
      the improvement of inspiratory muscle function and breathlessness in patients with chronic
      lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle
      endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of
      life in patients with interstitial lung disease. It is a quasi-experimental study. Patients
      with interstitial lung disease are recruited from interstitial disease ambulatory. In each
      session patients performs two times 30 breaths with a minute rest between them. The load is
      set according with 50% of actual PImax, the Borg score should be between 4 and 6, otherwise
      the load will decrease (if Borg more than 6) or increase (if Borg less than 4). New PImax is
      measured weekly and the new load is defined following the same protocol for 8 weeks. Patients
      are evaluated before the inspiratory muscle training and after 8 weeks of training.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Quasi-experimental
primary purpose: Other
masking: None (Open Label)
measure: Change in Inspiratory muscle endurance
time frame: At baseline and after 8 weeks of training
description: Endurance time in seconds
measure: Change in Breathlessness
time frame: At baseline and after 8 weeks of training
description: Medical Research Council (1-5)
measure: Change in Inspiratory muscle strength
time frame: At baseline and after 8 weeks of training
description: Maximal inspiratory pressure in cmH20
measure: Change in Functional capacity
time frame: At baseline and after 8 weeks of training
description: Maximal distance in 6 minute walk test
measure: Change in Quality of life
time frame: At baseline and after 8 weeks of training
description: King's Brief Interstitial Lung Disease Questionnaire. It is a 15 questions questionnaire. Total score can go from 0 - 100, 100 is the better quality of life.
arm group label: Inspiratory muscle training group
arm group type: Experimental
description: Group intervention: home-based interval inspiratory muscle training during 8 weeks, two sessions with two sets of 30 breaths with one minute rest between them. Load set is determinated weekly, aiming 50% of actual PImax and according to Borg Score.
intervention type: Other
intervention name: Inspiratory muscle training
description: Inspiratory muscle training will be performed using the tapered flow-resistive loading trainer (POWERbreathe®).
arm group label: Inspiratory muscle training group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Minas Gerais
investigator full name: Veronica Franco Parreira
investigator title: Full Professor
mesh term: Lung Diseases
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Respiratory Aspiration
mesh term: Lung Diseases, Interstitial
mesh term: Sarcoidosis
mesh term: Fibrosis