<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/NCT02226406</url>
  </required_header>
  <id_info>
    <org_study_id>EIT-Early Exercise</org_study_id>
    <nct_id>NCT02226406</nct_id>
  </id_info>
  <brief_title>Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment</brief_title>
  <acronym>EFRA</acronym>
  <official_title>Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment Evaluated With Electric Impedance Tomography.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the critically patient bed rest and immobilization are some of the responsable of the&#xD;
      development of respiratory complications. Early physical exercise is a tool to prevent&#xD;
      respiratory complications as lost of respiratory muscle strength, decrease in functional&#xD;
      residual capacity and hypoxemia improving oxygenation.&#xD;
&#xD;
      New technology as electrical impedance tomography (EIT) are available to visualize changes of&#xD;
      regional lung aeration.&#xD;
&#xD;
      The aim of this study is to assess the effect of early physical exercise improving alveolar&#xD;
      recruitment and pulmonary ventilation in intensive care unit (ICU) patients, evaluated with&#xD;
      EIT.&#xD;
&#xD;
      The ICU patients included at day of evaluation will be evaluated continuously with EIT in&#xD;
      different positions. 1) in the supine position (at 30° of inclination), 2) Sitting in chair&#xD;
      3) Active physical exercise 4) And rest in chair after exercise&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pulmonary electric impedance tomography (EIT) before, during and after single session of exercise.</measure>
    <time_frame>Meassure of EIT after 10 minutes of exercise and will be compared with baseline EIT</time_frame>
    <description>The change in pulmonary recruitment and ventilation will be evaluated with electric impedance tomography (EIT) in single session of exercise. First measure will be made for five minutes with EIT, before the exercise, then second measure will be made during exercise for ten minutes with EIT and finally last measure will be made after exercise for twenty minutes with EIT. All impedanciometries obtained in the patient in different activities will compare each.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PaO2 before, during and after single session of exercise</measure>
    <time_frame>Measure of PaO2 after 20 minutes of exercise and will compared with baseline PaO2</time_frame>
    <description>Before exercise will be taken a sample of arterial blood gases for determinate the initial PaO2 of the patient. Twenty minutes after exercise will be taken a new sample of arterial blood gases to establish the difference between PaO2 before exercise and after exercise.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Legs Cycloergometer Group (A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized in this group will do 10 minutes of legs cycloergometer active exercise. Continuously evaluated with electric impedance tomography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hands Cycloergometer Group (B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized in this group will do 10 minutes of hand cycloergometer active exercise. Continuously evaluated with electric impedance tomography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walk in place (C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized in this group will do 10 minutes of active walk in place. Continuously evaluated with electric impedance tomography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A: Chair - Leg Cycle ergometer</intervention_name>
    <arm_group_label>Legs Cycloergometer Group (A)</arm_group_label>
    <other_name>Exercise Bike</other_name>
    <other_name>Early mobilization</other_name>
    <other_name>Early physical therapy</other_name>
    <other_name>Early physical rehabilitation</other_name>
    <other_name>Early physical training</other_name>
    <other_name>Early physiotherapy</other_name>
    <other_name>Very early mobilization</other_name>
    <other_name>Early exercise</other_name>
    <other_name>Early activity</other_name>
    <other_name>Early mobility therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>B: Chair - Arm Cycle ergometer</intervention_name>
    <arm_group_label>Hands Cycloergometer Group (B)</arm_group_label>
    <other_name>Handcycle</other_name>
    <other_name>Early mobilization</other_name>
    <other_name>Early physical therapy</other_name>
    <other_name>Early physical rehabilitation</other_name>
    <other_name>Early physical training</other_name>
    <other_name>Early physiotherapy</other_name>
    <other_name>Very early mobilization</other_name>
    <other_name>Early exercise</other_name>
    <other_name>Early activity</other_name>
    <other_name>Early mobility therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>C: Walk in place</intervention_name>
    <arm_group_label>Walk in place (C)</arm_group_label>
    <other_name>Early mobilization</other_name>
    <other_name>March</other_name>
    <other_name>Static walk</other_name>
    <other_name>Early physical therapy</other_name>
    <other_name>Early physical rehabilitation</other_name>
    <other_name>Early physical training</other_name>
    <other_name>Early physiotherapy</other_name>
    <other_name>Very early mobilization</other_name>
    <other_name>Early exercise</other_name>
    <other_name>Early activity</other_name>
    <other_name>Early mobility therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient admitted at the Intensive Care Medical/Surgical Unit of Clinic Saint Luc&#xD;
&#xD;
          -  Days of hospitalization between 1 and 10&#xD;
&#xD;
          -  Hemodynamically stable&#xD;
&#xD;
          -  Patient or family member sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With risk of evisceration&#xD;
&#xD;
          -  Therapy withdrawal&#xD;
&#xD;
          -  With cardiac devices (Pace Maker)&#xD;
&#xD;
          -  Persistent cough&#xD;
&#xD;
          -  Patches or open wounds in zone of electrodes&#xD;
&#xD;
          -  Presence of high vasopressor medication (noradrenaline &gt; 3 mg/h)&#xD;
&#xD;
          -  PEEP &gt; 15 cm H2&#xD;
&#xD;
          -  Acute Myocardial Infarction&#xD;
&#xD;
          -  Active bleeding&#xD;
&#xD;
          -  Intracranial pressure &gt; 20 mm Hg or with major instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Arriagada, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ursula Jeria, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cheryl Hickmann, PT, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean Roeseler, PT, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre-François Laterre, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)</name>
      <address>
        <city>Brussel</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>January 13, 2015</last_update_submitted>
  <last_update_submitted_qc>January 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early Physical Exercise</keyword>
  <keyword>Alveolar Recruitment</keyword>
  <keyword>Electrical Impedance Tomography</keyword>
  <keyword>Oxygenation</keyword>
  <keyword>Ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT02226406
org study id: EIT-Early Exercise
nct id: NCT02226406
lead sponsor: 
has dmc: Yes
In the critically patient bed rest and immobilization are some of the responsable of the
      development of respiratory complications. Early physical exercise is a tool to prevent
      respiratory complications as lost of respiratory muscle strength, decrease in functional
      residual capacity and hypoxemia improving oxygenation.

      New technology as electrical impedance tomography (EIT) are available to visualize changes of
      regional lung aeration.

      The aim of this study is to assess the effect of early physical exercise improving alveolar
      recruitment and pulmonary ventilation in intensive care unit (ICU) patients, evaluated with
      EIT.

      The ICU patients included at day of evaluation will be evaluated continuously with EIT in
      different positions. 1) in the supine position (at 30° of inclination), 2) Sitting in chair
      3) Active physical exercise 4) And rest in chair after exercise
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in pulmonary electric impedance tomography (EIT) before, during and after single session of exercise.
time frame: Meassure of EIT after 10 minutes of exercise and will be compared with baseline EIT
description: The change in pulmonary recruitment and ventilation will be evaluated with electric impedance tomography (EIT) in single session of exercise. First measure will be made for five minutes with EIT, before the exercise, then second measure will be made during exercise for ten minutes with EIT and finally last measure will be made after exercise for twenty minutes with EIT. All impedanciometries obtained in the patient in different activities will compare each.
measure: Change in PaO2 before, during and after single session of exercise
time frame: Measure of PaO2 after 20 minutes of exercise and will compared with baseline PaO2
description: Before exercise will be taken a sample of arterial blood gases for determinate the initial PaO2 of the patient. Twenty minutes after exercise will be taken a new sample of arterial blood gases to establish the difference between PaO2 before exercise and after exercise.
arm group label: Legs Cycloergometer Group (A)
arm group type: Experimental
description: Patients randomized in this group will do 10 minutes of legs cycloergometer active exercise. Continuously evaluated with electric impedance tomography.
arm group label: Hands Cycloergometer Group (B)
arm group type: Experimental
description: Patients randomized in this group will do 10 minutes of hand cycloergometer active exercise. Continuously evaluated with electric impedance tomography.
arm group label: Walk in place (C)
arm group type: Experimental
description: Patients randomized in this group will do 10 minutes of active walk in place. Continuously evaluated with electric impedance tomography.
intervention type: Other
intervention name: A: Chair - Leg Cycle ergometer
arm group label: Legs Cycloergometer Group (A)
other name: Exercise Bike
other name: Early mobilization
other name: Early physical therapy
other name: Early physical rehabilitation
other name: Early physical training
other name: Early physiotherapy
other name: Very early mobilization
other name: Early exercise
other name: Early activity
other name: Early mobility therapy
intervention type: Other
intervention name: B: Chair - Arm Cycle ergometer
arm group label: Hands Cycloergometer Group (B)
other name: Handcycle
other name: Early mobilization
other name: Early physical therapy
other name: Early physical rehabilitation
other name: Early physical training
other name: Early physiotherapy
other name: Very early mobilization
other name: Early exercise
other name: Early activity
other name: Early mobility therapy
intervention type: Other
intervention name: C: Walk in place
arm group label: Walk in place (C)
other name: Early mobilization
other name: March
other name: Static walk
other name: Early physical therapy
other name: Early physical rehabilitation
other name: Early physical training
other name: Early physiotherapy
other name: Very early mobilization
other name: Early exercise
other name: Early activity
other name: Early mobility therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ricardo Arriagada, PT
role: Principal Investigator
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
last name: Ursula Jeria, PT
role: Principal Investigator
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
last name: Cheryl Hickmann, PT, PhD student
role: Principal Investigator
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
last name: Jean Roeseler, PT, PhD
role: Study Director
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
last name: Pierre-François Laterre, MD
role: Study Chair
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Critical Illness