<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/NCT03765489</url>
  </required_header>
  <id_info>
    <org_study_id>OAIC 847/16</org_study_id>
    <nct_id>NCT03765489</nct_id>
  </id_info>
  <brief_title>Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock</brief_title>
  <official_title>Electrical Muscle Stimulation in the Development of Acquired Weakness in the Intensive Care Unit in Adult Patients With Severe Sepsis and Septic Shock at the Clinic Hospital of the Univerisity of Chile: Results of a Pilot Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the effect of EMS and conventional physical therapy on&#xD;
      strength and muscle mass and development in adult patients with severe sepsis and septic&#xD;
      shock.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW).&#xD;
      Electrical muscle stimulation (EMS) has become an alternative exercise for critical and&#xD;
      non-cooperative patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 18, 2016</start_date>
  <completion_date type="Actual">June 21, 2018</completion_date>
  <primary_completion_date type="Actual">June 21, 2018</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intensive care unit acquired weakness</measure>
    <time_frame>at awakening of the subject, an average of 8 days</time_frame>
    <description>Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>muscle strength</measure>
    <time_frame>at awakening of the subject, an average of 8 days</time_frame>
    <description>Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle mass</measure>
    <time_frame>at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days</time_frame>
    <description>ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximum inspiratory pressure</measure>
    <time_frame>at awakening of the subject, an average of 8 days</time_frame>
    <description>maximum inspiratory pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days of mechanical ventilation</measure>
    <time_frame>an average of 11 days</time_frame>
    <description>number of days wirh mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with weaning failure</measure>
    <time_frame>48 hours post extubation day</time_frame>
    <description>Number of Participants who presented reintubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days of ICU stay</measure>
    <time_frame>at ICU discharge, an average of 18 days</time_frame>
    <description>number of days in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality at 28 days</measure>
    <time_frame>at 28 days post ICU admission</time_frame>
    <description>mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gait ability at hospital discharge</measure>
    <time_frame>at hospital discharge, an averange of 3 months</time_frame>
    <description>presence or not of gait ability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Polyneuropathies</condition>
  <condition>Septic Shock</condition>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>electrical muscle stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>conventional physical therapy according to the adaptation of the &quot;Start to move&quot; protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional physical therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional physical therapy according to the adaptation of the &quot;Start to move&quot; protocol of Gosselink et al</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>electrical muscle stimulation</intervention_name>
    <description>electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction</description>
    <arm_group_label>electrical muscle stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional physical therapy</intervention_name>
    <description>conventional physical therapy according to the adaptation of the &quot;Start to move&quot; protocol of Gosselink et al</description>
    <arm_group_label>conventional physical therapy</arm_group_label>
    <arm_group_label>electrical muscle stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects admitted to the ICU of the HCUCH in the period between November 2016 to&#xD;
             August 2017 and January to June 2018&#xD;
&#xD;
          -  Diagnosis of severe sepsis or septic shock&#xD;
&#xD;
          -  More than 48 hours in VMI&#xD;
&#xD;
          -  With sedation and / or neuromuscular blockade&#xD;
&#xD;
          -  Autovalent prior to admission to the ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects from other hospitals / clinics or units of the hospital&#xD;
&#xD;
          -  Multiple trauma&#xD;
&#xD;
          -  Previous neuromuscular pathology&#xD;
&#xD;
          -  Pacemaker users&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  BMI&gt; 35&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Those who have refused to sign informed consent&#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>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>daniel arellano sepulveda</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>polyneuropathies</keyword>
  <keyword>muscle weakness</keyword>
  <keyword>sepsis</keyword>
  <keyword>septic shock</keyword>
  <keyword>electrical stimulation</keyword>
  <keyword>intensive care unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Polyneuropathies</mesh_term>
    <mesh_term>Paresis</mesh_term>
    <mesh_term>Shock</mesh_term>
    <mesh_term>Asthenia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 17, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03765489/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 17, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03765489/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03765489
org study id: OAIC 847/16
nct id: NCT03765489
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The aim of this study is to compare the effect of EMS and conventional physical therapy on
      strength and muscle mass and development in adult patients with severe sepsis and septic
      shock.
Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW).
      Electrical muscle stimulation (EMS) has become an alternative exercise for critical and
      non-cooperative patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: intensive care unit acquired weakness
time frame: at awakening of the subject, an average of 8 days
description: Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness
measure: muscle strength
time frame: at awakening of the subject, an average of 8 days
description: Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength).
measure: muscle mass
time frame: at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days
description: ultrasonography
measure: maximum inspiratory pressure
time frame: at awakening of the subject, an average of 8 days
description: maximum inspiratory pressure
measure: days of mechanical ventilation
time frame: an average of 11 days
description: number of days wirh mechanical ventilation
measure: Number of Participants with weaning failure
time frame: 48 hours post extubation day
description: Number of Participants who presented reintubation
measure: days of ICU stay
time frame: at ICU discharge, an average of 18 days
description: number of days in ICU
measure: mortality at 28 days
time frame: at 28 days post ICU admission
description: mortality
measure: gait ability at hospital discharge
time frame: at hospital discharge, an averange of 3 months
description: presence or not of gait ability
arm group label: electrical muscle stimulation
arm group type: Experimental
description: conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction
arm group label: conventional physical therapy
arm group type: Active Comparator
description: conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al
intervention type: Device
intervention name: electrical muscle stimulation
description: electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction
arm group label: electrical muscle stimulation
intervention type: Procedure
intervention name: conventional physical therapy
description: conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al
arm group label: conventional physical therapy
arm group label: electrical muscle stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: daniel arellano sepulveda
investigator title: principal investigator
mesh term: Sepsis
mesh term: Shock, Septic
mesh term: Muscle Weakness
mesh term: Polyneuropathies
mesh term: Paresis
mesh term: Shock
mesh term: Asthenia
provided document: 
provided document: 