<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/NCT01717833</url>
  </required_header>
  <id_info>
    <org_study_id>SN01032010</org_study_id>
    <nct_id>NCT01717833</nct_id>
  </id_info>
  <brief_title>The Role of NEMS for Post ICU Rehabilitation</brief_title>
  <official_title>The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Athens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the role of NEMS as a rehabilitation tool for&#xD;
      muscle weakness following critical illness. The investigators hypothesized that NEMS combined&#xD;
      with exercise rehabilitation will have a beneficial role in restoration of muscle strength&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Survivors of critical illness are presented with significant physical impairment that is&#xD;
      associated with reduced functional ability and health -related quality of life both in the&#xD;
      short and long-term.&#xD;
&#xD;
      Neuromuscular electrical stimulation (NEMS) has been proposed as an alternative exercise&#xD;
      modality in patients with severe chronic obstructive pulmonary disease and chronic heart&#xD;
      failure, who cannot perform active exercise. NEMS has also been used as a preventive tool for&#xD;
      intensive care unit (ICU) acquired weakness (ICUAW). Its role as a tool for post ICU&#xD;
      rehabilitation has not been evaluated so far.&#xD;
&#xD;
      A randomized intervention study was designed to assess the efficacy of NEMS, as a&#xD;
      rehabilitative tool for critical illness survivors. The first day that patients are&#xD;
      discharged from the ICU after stratified randomization are assigned to the NEMS group or to&#xD;
      the control group. In the NEMS group, NEMS will be applied to both lower extremities of the&#xD;
      NEMS -group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis,&#xD;
      along with a personalized exercise program. NEMS sessions will continue until patient&#xD;
      discharge from hospital. In the control group, sham NEMS will be applied along with standard&#xD;
      care when it comes to physiotherapy. At hospital discharge patients of both groups of will&#xD;
      receive a rehabilitation booklet. Patients on the NEMS group that have significant muscle&#xD;
      weakness will have NEMS sessions at home for a period of 2 months. Patients are evaluated at&#xD;
      3 and 6 months after hospital discharge&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2010</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>up to 2.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>up to 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional ability</measure>
    <time_frame>up to 2.5 years</time_frame>
    <description>Functional ability will be assessed with the FIM score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>up to 2.5 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge</measure>
    <time_frame>up to 2.5 years</time_frame>
    <description>In the subgroup of patients diagnosed with ICUAW improvement in muscle strength will be assessed in patients of the NEMS group as compared to the sham-NEMS group</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>NEMS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>NEMS</intervention_name>
    <description>NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously</description>
    <arm_group_label>NEMS group</arm_group_label>
    <other_name>Neuromuscular Electrical stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>Sham sessions of neuromuscular electrical stimulation</description>
    <arm_group_label>Sham group</arm_group_label>
    <other_name>Sham neuromuscular electrical stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients under mechanical ventilation for&gt; 72hours during ICU stay&#xD;
&#xD;
          -  Patients able to perform simple commands (able to be evaluated by MRC scale)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 &gt; 85 years&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  pre-existing neuromuscular disease (e.g. Gravis)&#xD;
&#xD;
          -  fractures or skin lesions that do not allow the implementation of NEMS&#xD;
&#xD;
          -  presence of pacemaker or defibrillator&#xD;
&#xD;
          -  fractures of spine that so not allow mobilization&#xD;
&#xD;
          -  BMI &gt; 35 kg/m2&#xD;
&#xD;
          -  terminal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serafim Nanas, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Athens</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>First Critical Care Unit, Evaggelismos Hospital, School of Medicine</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>June 17, 2015</last_update_submitted>
  <last_update_submitted_qc>June 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Athens</investigator_affiliation>
    <investigator_full_name>Serafim Nanas</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>ICU acquired weakness</keyword>
  <keyword>Critical illness polyneuromyopathy</keyword>
  <keyword>post ICU rehabilitation</keyword>
  <keyword>neuromuscular electrical rehabilitation</keyword>
  <keyword>handgrip</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/NCT01717833
org study id: SN01032010
nct id: NCT01717833
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the role of NEMS as a rehabilitation tool for
      muscle weakness following critical illness. The investigators hypothesized that NEMS combined
      with exercise rehabilitation will have a beneficial role in restoration of muscle strength
Survivors of critical illness are presented with significant physical impairment that is
      associated with reduced functional ability and health -related quality of life both in the
      short and long-term.

      Neuromuscular electrical stimulation (NEMS) has been proposed as an alternative exercise
      modality in patients with severe chronic obstructive pulmonary disease and chronic heart
      failure, who cannot perform active exercise. NEMS has also been used as a preventive tool for
      intensive care unit (ICU) acquired weakness (ICUAW). Its role as a tool for post ICU
      rehabilitation has not been evaluated so far.

      A randomized intervention study was designed to assess the efficacy of NEMS, as a
      rehabilitative tool for critical illness survivors. The first day that patients are
      discharged from the ICU after stratified randomization are assigned to the NEMS group or to
      the control group. In the NEMS group, NEMS will be applied to both lower extremities of the
      NEMS -group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis,
      along with a personalized exercise program. NEMS sessions will continue until patient
      discharge from hospital. In the control group, sham NEMS will be applied along with standard
      care when it comes to physiotherapy. At hospital discharge patients of both groups of will
      receive a rehabilitation booklet. Patients on the NEMS group that have significant muscle
      weakness will have NEMS sessions at home for a period of 2 months. Patients are evaluated at
      3 and 6 months after hospital discharge
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Muscle strength
time frame: up to 2.5 years
measure: Duration of hospital stay
time frame: up to 2.5 years
measure: Functional ability
time frame: up to 2.5 years
description: Functional ability will be assessed with the FIM score
measure: Quality of life
time frame: up to 2.5 years
measure: Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge
time frame: up to 2.5 years
description: In the subgroup of patients diagnosed with ICUAW improvement in muscle strength will be assessed in patients of the NEMS group as compared to the sham-NEMS group
arm group label: NEMS group
arm group type: Experimental
arm group label: Sham group
arm group type: Sham Comparator
intervention type: Procedure
intervention name: NEMS
description: NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously
arm group label: NEMS group
other name: Neuromuscular Electrical stimulation
intervention type: Procedure
intervention name: Sham
description: Sham sessions of neuromuscular electrical stimulation
arm group label: Sham group
other name: Sham neuromuscular electrical stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Serafim Nanas, Professor
role: Principal Investigator
affiliation: University of Athens
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University of Athens
investigator full name: Serafim Nanas
investigator title: Professor
mesh term: Critical Illness