<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/NCT04507451</url>
  </required_header>
  <id_info>
    <org_study_id>RESP-USI</org_study_id>
    <nct_id>NCT04507451</nct_id>
  </id_info>
  <brief_title>Respiratory Muscle Training in ICU Patients</brief_title>
  <official_title>Inspiratory and Expiratory Muscle Training in Critically Ill Patients Weaned From Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</source>
  <oversight_info>
    <has_dmc>No</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>
      Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can&#xD;
      limit functional recovery. Respiratory muscle training is often neglected in clinical&#xD;
      practice. Some data indicates that inspiratory muscle training increases inspiratory muscle&#xD;
      strength and quality of life. The aim of the study is to assess the impact of combined&#xD;
      inspiratory and expiratory muscle training on inspiratory muscle strength. The second aim is&#xD;
      to assess the impact of this training program on expiratory muscle strength.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>patients are masked: they will all benefit from respiratory physiotherapy, with placebo or real muscle training investigator and care providers are unmasked, as they set the training parameters</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>change in inspiratory muscle strength</measure>
    <time_frame>between 7 to 15 days after ICU discharge (compared to ICU discharge)</time_frame>
    <description>measurement of maximal inspiratory pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in inspiratory muscle strength</measure>
    <time_frame>1 month after ICU discharge (compared to ICU discharge)</time_frame>
    <description>measurement of maximal inspiratory pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in expiratory muscle strength</measure>
    <time_frame>between 7 to 15 days after ICU discharge (compared to ICU discharge)</time_frame>
    <description>measurement of maximal expiratory pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in expiratory muscle strength</measure>
    <time_frame>1 month after ICU discharge (compared to ICU discharge)</time_frame>
    <description>measurement of maximal expiratory pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>respiratory infections</measure>
    <time_frame>1 month after ICU discharge</time_frame>
    <description>number of respiratory infections requiring antibiotics after ICU discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in dyspnea perception</measure>
    <time_frame>1 month after ICU discharge (compared to hospital discharge)</time_frame>
    <description>assessed using Dyspnea-12 questionnaire (score from 0 to 36, 36 indicating a maximal dyspnea)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>impact of dyspnea on physical activities</measure>
    <time_frame>between 7 to 15 days after ICU discharge</time_frame>
    <description>assessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>impact of dyspnea on physical activities</measure>
    <time_frame>1 month after ICU discharge</time_frame>
    <description>assessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Critical Illness</condition>
  <condition>Inspiratory Muscle Strength</condition>
  <condition>Mechanical Ventilation</condition>
  <condition>Respiratory Muscle Training</condition>
  <arm_group>
    <arm_group_label>Trained group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle training. This program will be delivered 5 days a week.&#xD;
Inspiratory muscle training (IMT): using a threshold IMT device with mouthpiece, 5 sets of 6 breaths, intensity is prescribed at 60% of maximal inspiratory pressure for the first set, and then increased to the highest tolerable intensity to allow completion of the 6th breath Expiratory muscle training (EMT): using a bottle filled with water, starting at 5cm and then increased to 8 cm gradually, 5 sets of 6 breaths&#xD;
Training program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untrained group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle exercises that are not planned to train muscles. This program will be delivered 5 days a week.&#xD;
Inspiratory exercises: fractionated inspiration, 5 sets of 6 breaths Expiratory exercises: using a bottle filled with water (1 cm)&#xD;
Exercises program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>inspiratory and expiratory muscle training</intervention_name>
    <description>inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water</description>
    <arm_group_label>Trained group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>inspiratory and expiratory exercises</intervention_name>
    <description>inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level</description>
    <arm_group_label>Untrained group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient from mechanical ventilation after at least 24 hours of support&#xD;
&#xD;
          -  collaborative patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  confusion, mental disorder&#xD;
&#xD;
          -  not french speaking&#xD;
&#xD;
          -  pulmonary surgery in the past 12 months&#xD;
&#xD;
          -  external ventricular drain&#xD;
&#xD;
          -  previous pneumothorax or pneumothorax not drained&#xD;
&#xD;
          -  rib fractures&#xD;
&#xD;
          -  alveolar hemorrhage&#xD;
&#xD;
          -  hemodynamic instability&#xD;
&#xD;
          -  labial occlusion impossible (face burn, facial paralysis)&#xD;
&#xD;
          -  patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anne-Françoise Rousseau, MD, PhD</last_name>
    <phone>+3243667495</phone>
    <email>afrousseau@chuliege.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital of Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Françoise Rousseau, PhD</last_name>
      <phone>+3243667495</phone>
      <email>afrousseau@chuliege.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Rousseau</investigator_full_name>
    <investigator_title>Head of clinic</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04507451
org study id: RESP-USI
nct id: NCT04507451
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can
      limit functional recovery. Respiratory muscle training is often neglected in clinical
      practice. Some data indicates that inspiratory muscle training increases inspiratory muscle
      strength and quality of life. The aim of the study is to assess the impact of combined
      inspiratory and expiratory muscle training on inspiratory muscle strength. The second aim is
      to assess the impact of this training program on expiratory muscle strength.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: patients are masked: they will all benefit from respiratory physiotherapy, with placebo or real muscle training investigator and care providers are unmasked, as they set the training parameters
measure: change in inspiratory muscle strength
time frame: between 7 to 15 days after ICU discharge (compared to ICU discharge)
description: measurement of maximal inspiratory pressure
measure: change in inspiratory muscle strength
time frame: 1 month after ICU discharge (compared to ICU discharge)
description: measurement of maximal inspiratory pressure
measure: change in expiratory muscle strength
time frame: between 7 to 15 days after ICU discharge (compared to ICU discharge)
description: measurement of maximal expiratory pressure
measure: change in expiratory muscle strength
time frame: 1 month after ICU discharge (compared to ICU discharge)
description: measurement of maximal expiratory pressure
measure: respiratory infections
time frame: 1 month after ICU discharge
description: number of respiratory infections requiring antibiotics after ICU discharge
measure: change in dyspnea perception
time frame: 1 month after ICU discharge (compared to hospital discharge)
description: assessed using Dyspnea-12 questionnaire (score from 0 to 36, 36 indicating a maximal dyspnea)
measure: impact of dyspnea on physical activities
time frame: between 7 to 15 days after ICU discharge
description: assessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing)
measure: impact of dyspnea on physical activities
time frame: 1 month after ICU discharge
description: assessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing)
arm group label: Trained group
arm group type: Experimental
description: Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle training. This program will be delivered 5 days a week.
Inspiratory muscle training (IMT): using a threshold IMT device with mouthpiece, 5 sets of 6 breaths, intensity is prescribed at 60% of maximal inspiratory pressure for the first set, and then increased to the highest tolerable intensity to allow completion of the 6th breath Expiratory muscle training (EMT): using a bottle filled with water, starting at 5cm and then increased to 8 cm gradually, 5 sets of 6 breaths
Training program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge
arm group label: Untrained group
arm group type: Placebo Comparator
description: Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle exercises that are not planned to train muscles. This program will be delivered 5 days a week.
Inspiratory exercises: fractionated inspiration, 5 sets of 6 breaths Expiratory exercises: using a bottle filled with water (1 cm)
Exercises program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge
intervention type: Procedure
intervention name: inspiratory and expiratory muscle training
description: inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water
arm group label: Trained group
intervention type: Procedure
intervention name: inspiratory and expiratory exercises
description: inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level
arm group label: Untrained group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne-Françoise Rousseau, MD, PhD
phone: +3243667495
email: afrousseau@chuliege.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Rousseau
investigator title: Head of clinic
mesh term: Respiratory Aspiration
mesh term: Critical Illness
sharing ipd: No