<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/NCT03758573</url>
  </required_header>
  <id_info>
    <org_study_id>IMT</org_study_id>
    <nct_id>NCT03758573</nct_id>
  </id_info>
  <brief_title>Effectiveness Inspirational Muscle Training</brief_title>
  <acronym>IMTversusMV</acronym>
  <official_title>Effectiveness of Early Inspirational Muscle Training in Patients Submitted to Mechanical Ventilation: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do vale do São Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do vale do São Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The long stay in mechanical ventilation can induce several complications, among them&#xD;
      respiratory muscle weakness, this has been related to the duration of mechanical ventilation,&#xD;
      delay and failure to wean, resulting in longer hospitalization, which reflects in greater&#xD;
      care increase in hospital costs. Therefore, of this research will be to compare the&#xD;
      effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients&#xD;
      undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning&#xD;
      time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will consist of a randomized controlled clinical trial conducted at the Intensive&#xD;
      Care Unit of the University Hospital of UNIVASF. Will be included individuals of both sexes,&#xD;
      aged 18 years or older, who are on invasive mechanical ventilation and who obtain the Free&#xD;
      and Informed Consent Form, signed by the responsible family member. Subjects will be&#xD;
      randomized into two groups (training and control). The inspiratory (MIP), expiratory (MEP)&#xD;
      and peak expiratory flow pressures will be evaluated. The training group will perform&#xD;
      respiratory muscle training, using the Powerbreath equipment, with initial loading of 40% of&#xD;
      MIP, 7 days a week, 2 times a day. Morbidities that have repercussions on diaphragmatic&#xD;
      contraction and end-stage disease will be used as exclusion criteria. The sample data will be&#xD;
      analyzed through the SPSS 22.0 program. The significance level of the study will be set at 5%&#xD;
      (p &lt;0.05).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>Compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weaning mechanical ventilation</measure>
    <time_frame>through study completion, an average of 15 days</time_frame>
    <description>time of mechanical ventilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of stay in the ICU</measure>
    <time_frame>through study completion, an average of 15 days</time_frame>
    <description>reduction length of stay in the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>extubation success</measure>
    <time_frame>through study completion, an average of 2 days</time_frame>
    <description>extubation success after 48 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>death</measure>
    <time_frame>yes or not death, through study completion, an average of 15 days</time_frame>
    <description>reduction in mortality (death)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Respiratory Insufficiency</condition>
  <arm_group>
    <arm_group_label>Inspiratory Muscle Training (IMT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMT by means of the Powerbreath equipment (Classic, London, UK), according to the following parameters: initial loading of 40% of MIP, 3 sets of 10 repetitions with interval of 1 minute between each sets, 7 days a week, 2 times a day , with the patients in the bed with the angulation of 45 °. The IMT load settings will be adjusted according to the values evaluated weekly. If there is need for addition of supplemental oxygen will be performed to perform the IMT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive Physiotherapy (IPT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IPT will be to individualized and supervised intervention program consisting of any of the following procedures: passive, assisted, active or resisted mobilization, sedation and orthostasis depending on the functional level of the patient, as well as bronchial hygiene therapy and pulmonary expansion therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inspiratory Muscle Training (IMT)</intervention_name>
    <description>Inspiratory Muscle Training (IMT)</description>
    <arm_group_label>Inspiratory Muscle Training (IMT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intensive Physiotherapy (IPT)</intervention_name>
    <description>Intensive Physiotherapy (IPT)</description>
    <arm_group_label>Intensive Physiotherapy (IPT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  invasive mechanical ventilation&#xD;
&#xD;
          -  patients hemodynamically stable&#xD;
&#xD;
          -  without use of vasoactive drugs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  spindle trauma&#xD;
&#xD;
          -  neuromuscular diseases&#xD;
&#xD;
          -  end-stage disease&#xD;
&#xD;
          -  pneumothorax&#xD;
&#xD;
          -  rib fracture&#xD;
&#xD;
          -  diaphragmatic injury&#xD;
&#xD;
          -  postoperative pulmonary surgeries&#xD;
&#xD;
          -  abdominal disease&#xD;
&#xD;
          -  morbidities that have repercussions on diaphragmatic contraction&#xD;
&#xD;
          -  mechanical ventilation with FiO2 &gt; 60% and PEEP &gt; 10 cm H2O&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo GS Carvalho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physical Education College / UNIVASF</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rodrigo GS Carvalho, PhD</last_name>
    <phone>+5587999832015</phone>
    <email>rodrigocarvalhofisio@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rodrigo GS Carvalho, PhD</last_name>
    <phone>+558721016856</phone>
    <email>rodrigo.carvalho@univasf.edu.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Physical Education College</name>
      <address>
        <city>Petrolina</city>
        <state>Pernambuco</state>
        <zip>56304917</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rodrigo GS Carvalho, PhD</last_name>
      <phone>8721016856</phone>
      <email>rodrigo.carvalho@univasf.edu.br</email>
    </contact>
    <contact_backup>
      <last_name>Rodrigo GS Carvalho, PhD</last_name>
      <phone>8721016856</phone>
      <email>rodrigocarvalhofisio@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do vale do São Francisco</investigator_affiliation>
    <investigator_full_name>Rodrigo Gustavo da Silva Carvalho</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breathing Exercises</keyword>
  <keyword>Respiratory Muscles</keyword>
  <keyword>Respiration Artificial</keyword>
  <keyword>Weaning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Registration ClinicalTrials; Study Protocol; Paper results.</ipd_description>
  </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/NCT03758573
org study id: IMT
nct id: NCT03758573
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The long stay in mechanical ventilation can induce several complications, among them
      respiratory muscle weakness, this has been related to the duration of mechanical ventilation,
      delay and failure to wean, resulting in longer hospitalization, which reflects in greater
      care increase in hospital costs. Therefore, of this research will be to compare the
      effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients
      undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning
      time.
The study will consist of a randomized controlled clinical trial conducted at the Intensive
      Care Unit of the University Hospital of UNIVASF. Will be included individuals of both sexes,
      aged 18 years or older, who are on invasive mechanical ventilation and who obtain the Free
      and Informed Consent Form, signed by the responsible family member. Subjects will be
      randomized into two groups (training and control). The inspiratory (MIP), expiratory (MEP)
      and peak expiratory flow pressures will be evaluated. The training group will perform
      respiratory muscle training, using the Powerbreath equipment, with initial loading of 40% of
      MIP, 7 days a week, 2 times a day. Morbidities that have repercussions on diaphragmatic
      contraction and end-stage disease will be used as exclusion criteria. The sample data will be
      analyzed through the SPSS 22.0 program. The significance level of the study will be set at 5%
      (p <0.05).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Weaning mechanical ventilation
time frame: through study completion, an average of 15 days
description: time of mechanical ventilation
measure: length of stay in the ICU
time frame: through study completion, an average of 15 days
description: reduction length of stay in the ICU
measure: extubation success
time frame: through study completion, an average of 2 days
description: extubation success after 48 hours
measure: death
time frame: yes or not death, through study completion, an average of 15 days
description: reduction in mortality (death)
arm group label: Inspiratory Muscle Training (IMT)
arm group type: Experimental
description: IMT by means of the Powerbreath equipment (Classic, London, UK), according to the following parameters: initial loading of 40% of MIP, 3 sets of 10 repetitions with interval of 1 minute between each sets, 7 days a week, 2 times a day , with the patients in the bed with the angulation of 45 °. The IMT load settings will be adjusted according to the values evaluated weekly. If there is need for addition of supplemental oxygen will be performed to perform the IMT.
arm group label: Intensive Physiotherapy (IPT)
arm group type: Active Comparator
description: IPT will be to individualized and supervised intervention program consisting of any of the following procedures: passive, assisted, active or resisted mobilization, sedation and orthostasis depending on the functional level of the patient, as well as bronchial hygiene therapy and pulmonary expansion therapy.
intervention type: Other
intervention name: Inspiratory Muscle Training (IMT)
description: Inspiratory Muscle Training (IMT)
arm group label: Inspiratory Muscle Training (IMT)
intervention type: Other
intervention name: Intensive Physiotherapy (IPT)
description: Intensive Physiotherapy (IPT)
arm group label: Intensive Physiotherapy (IPT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rodrigo GS Carvalho, PhD
role: Principal Investigator
affiliation: Physical Education College / UNIVASF
last name: Rodrigo GS Carvalho, PhD
phone: +5587999832015
email: rodrigocarvalhofisio@gmail.com
last name: Rodrigo GS Carvalho, PhD
phone: +558721016856
email: rodrigo.carvalho@univasf.edu.br
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do vale do São Francisco
investigator full name: Rodrigo Gustavo da Silva Carvalho
investigator title: Principal Investigator
mesh term: Respiratory Insufficiency
sharing ipd: No
ipd description: Registration ClinicalTrials; Study Protocol; Paper results.