<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/NCT02185989</url>
  </required_header>
  <id_info>
    <org_study_id>CHRO 2014-001</org_study_id>
    <secondary_id>ID RCB : 2014-A00566-41</secondary_id>
    <nct_id>NCT02185989</nct_id>
  </id_info>
  <brief_title>Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU</brief_title>
  <acronym>PROMOREA1</acronym>
  <official_title>Early Rehabilitation Combining Daily Electrical Muscle Stimulation and Early Bedside Cycling Exercise, Compared to Early Standard Rehabilitation. A Randomized, Assessor-blinded, Single-center Study in Intensive Care Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional d'Orléans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Régional d'Orléans</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early mobilization (from the first day if possible), first passive and then passive and&#xD;
      active, is recommended for critically ill patients in whom it reduces the duration of&#xD;
      mechanical ventilation, the length of hospital stay, improves functional status, muscle&#xD;
      strength and quality of life after hospital discharge. The early addition of leg bicycling on&#xD;
      a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve&#xD;
      muscle strength and further increase the beneficial effects of early mobilization. Electrical&#xD;
      muscle stimulation of the quadriceps, is practiced in some intensive care units, and it&#xD;
      should, in theory, also through an improvement of muscle strength, increase the beneficial&#xD;
      effects of early mobilization.&#xD;
&#xD;
      We hypothesized that early quadriceps electrical stimulation and early work on a&#xD;
      cyclo-ergometer associated with a standard protocol of early passive/active mobilization in&#xD;
      the ICU may improve muscle function and reduce the duration of mechanical ventilation, length&#xD;
      of stay, the number of readmissions and improve the quality of life in the mid term in&#xD;
      critically ill patients, as compared to a conventional protocol of early passive/active&#xD;
      mobilization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2014</start_date>
  <completion_date type="Actual">November 24, 2016</completion_date>
  <primary_completion_date type="Actual">November 24, 2016</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global muscle strength assessed by the MRC (Medical research Council, 1978) score</measure>
    <time_frame>on the day of ICU discharge (+/- 1 day)</time_frame>
    <description>Global muscle strength assessed by the MRC (Medical research Council, 1978) score on the day of ICU discharge (+/- 1 day) in all enrolled patients discharged alive from the ICU. This evaluation will be conducted by a physiotherapist blinded to the randomization group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in thickness of the rectus femoris muscle of each thigh</measure>
    <time_frame>from inclusion to ICU discharge (+ / - 1 day)</time_frame>
    <description>Changes in thickness of the rectus femoris muscle of each thigh, as measured by ultrasound imaging, between inclusion and ICU discharge (+ / - 1 day).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of delirium in the ICU.</measure>
    <time_frame>During ICU stay</time_frame>
    <description>Delirium is defined by the CAM-ICU scale (Ely CCM 2001 Ely JAMA 2001).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 months after ICU discharge</time_frame>
    <description>Quality of life 6 months after ICU discharge assessed by the SF-36 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">314</enrollment>
  <condition>ICU-acquired Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Electrical muscle stimulation and bicycling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo early electrical stimulation of the quadriceps and early leg bicycling in addition to routine care (which comprises early standard mobilization)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard early passive/active rehabilitation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this control group, patients will undergo routine care that comprises standard early passive/active rehabilitation delivered by physiotherapist with the assistance of ICU nurses</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early electrical stimulation and early leg bicycling added to early standard rehabilitation</intervention_name>
    <arm_group_label>Electrical muscle stimulation and bicycling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 18 yrs&#xD;
&#xD;
          -  expected length of stay in the ICU higher than 72 hours&#xD;
&#xD;
          -  motor autonomy sufficient for independent ambulation (ass assessed by&#xD;
             patient/family/familial practitioner interview&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Opposition expressed by the patient, his/her legal representative or a member of&#xD;
             his/her family&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Resuscitated cardiac arrest before inclusion&#xD;
&#xD;
          -  Patient carrying a pacemaker or an implantable defibrillator&#xD;
&#xD;
          -  Patient under extracorporeal membrane oxygenation&#xD;
&#xD;
          -  Severe acute cerebral disease requiring deep sedation&#xD;
&#xD;
          -  Brain death&#xD;
&#xD;
          -  Guillain-Barré syndrome&#xD;
&#xD;
          -  Myasthenia gravis&#xD;
&#xD;
          -  Known Dementia than can affect the main endpoint assessment&#xD;
&#xD;
          -  Deep venous thrombosis or pulmonary embolism treated for less than 48 hours, or&#xD;
             floating clot in femoral, iliac of inferior vena cava veins&#xD;
&#xD;
          -  Unstable traumatic injuries of the spine&#xD;
&#xD;
          -  Severe skin disease or surgical reasons that either prevent performing&#xD;
             electrostimulation or bicycling in the next 2 days, or prevent patient's&#xD;
             verticalization or transfer to chair in the next 5 days&#xD;
&#xD;
          -  Amputation of a lower limb at the trans-metatarsal level or higher&#xD;
&#xD;
          -  Inclusion in another interventional study with muscle strength assessment as the&#xD;
             primary endpoint&#xD;
&#xD;
          -  Moribund patient&#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>Thierry Boulain, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Régional d'Orléans, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Régional d'Orléans</name>
      <address>
        <city>Orléans</city>
        <zip>45000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Critical Illness/*rehabilitation</keyword>
  <keyword>Humans</keyword>
  <keyword>*Intensive Care Units</keyword>
  <keyword>Muscle Weakness/diagnosis/*etiology/physiopathology/prevention &amp; control</keyword>
  <keyword>Polyneuropathies/diagnosis/*etiology/physiopathology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Paresis</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/NCT02185989
org study id: CHRO 2014-001
secondary id: ID RCB : 2014-A00566-41
nct id: NCT02185989
lead sponsor: 
has dmc: No
Early mobilization (from the first day if possible), first passive and then passive and
      active, is recommended for critically ill patients in whom it reduces the duration of
      mechanical ventilation, the length of hospital stay, improves functional status, muscle
      strength and quality of life after hospital discharge. The early addition of leg bicycling on
      a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve
      muscle strength and further increase the beneficial effects of early mobilization. Electrical
      muscle stimulation of the quadriceps, is practiced in some intensive care units, and it
      should, in theory, also through an improvement of muscle strength, increase the beneficial
      effects of early mobilization.

      We hypothesized that early quadriceps electrical stimulation and early work on a
      cyclo-ergometer associated with a standard protocol of early passive/active mobilization in
      the ICU may improve muscle function and reduce the duration of mechanical ventilation, length
      of stay, the number of readmissions and improve the quality of life in the mid term in
      critically ill patients, as compared to a conventional protocol of early passive/active
      mobilization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Global muscle strength assessed by the MRC (Medical research Council, 1978) score
time frame: on the day of ICU discharge (+/- 1 day)
description: Global muscle strength assessed by the MRC (Medical research Council, 1978) score on the day of ICU discharge (+/- 1 day) in all enrolled patients discharged alive from the ICU. This evaluation will be conducted by a physiotherapist blinded to the randomization group
measure: Changes in thickness of the rectus femoris muscle of each thigh
time frame: from inclusion to ICU discharge (+ / - 1 day)
description: Changes in thickness of the rectus femoris muscle of each thigh, as measured by ultrasound imaging, between inclusion and ICU discharge (+ / - 1 day).
measure: Frequency of delirium in the ICU.
time frame: During ICU stay
description: Delirium is defined by the CAM-ICU scale (Ely CCM 2001 Ely JAMA 2001).
measure: Quality of life
time frame: 6 months after ICU discharge
description: Quality of life 6 months after ICU discharge assessed by the SF-36 questionnaire
arm group label: Electrical muscle stimulation and bicycling
arm group type: Active Comparator
description: Patients will undergo early electrical stimulation of the quadriceps and early leg bicycling in addition to routine care (which comprises early standard mobilization)
arm group label: Standard early passive/active rehabilitation
arm group type: No Intervention
description: In this control group, patients will undergo routine care that comprises standard early passive/active rehabilitation delivered by physiotherapist with the assistance of ICU nurses
intervention type: Other
intervention name: Early electrical stimulation and early leg bicycling added to early standard rehabilitation
arm group label: Electrical muscle stimulation and bicycling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thierry Boulain, MD
role: Principal Investigator
affiliation: Centre Hospitalier Régional d'Orléans, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Muscle Weakness
mesh term: Paresis