<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/NCT02210585</url>
  </required_header>
  <id_info>
    <org_study_id>38RC13.554</org_study_id>
    <nct_id>NCT02210585</nct_id>
  </id_info>
  <brief_title>Study of Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient</brief_title>
  <acronym>STIMOBIII</acronym>
  <official_title>Study of Multi-site Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient Carrying Severe Inactive: Randomized Controlled Trial vs Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was designed to test the following hypotheses:&#xD;
&#xD;
      Main Objective:&#xD;
&#xD;
      To compare the level of spontaneous physical activity at 3 months after re-entrainment by&#xD;
      multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to&#xD;
      conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation)&#xD;
      (control arm).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical&#xD;
      activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      We will conduct a multicenter controlled study vs. reference care with randomization into two&#xD;
      parallel groups and double-blind (placebo electrostimulation). Patients will have the ES&#xD;
      material available at home and will be supervised by monthly visits over 3 months and by&#xD;
      telephone follow-up for two years. The study size calculation is based on physical activity,&#xD;
      the percentage of lean body mass and arterial stiffness measured in the OBEX study.&#xD;
&#xD;
      This project will determine whether the training strategy is effective for increasing&#xD;
      physical activity and/or in inducing significant metabolic and cardiovascular effects in&#xD;
      these patients after 2 years. In addition, it provides a solid base of investigation for the&#xD;
      study of the interactions between muscle contraction and cardio-metabolic health with greater&#xD;
      precision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular&#xD;
      risk. Furthermore, both diseases are associated with reduced exercise tolerance.&#xD;
&#xD;
      For many patients with morbid obesity, the implementation of physical activity programs&#xD;
      remains difficult for several reasons including the level of disability and psychosocial&#xD;
      causes (the scrutiny of others, depression and poorly adapted equipment).&#xD;
&#xD;
      Main hypothesis: Neuromuscular electrostimulation is a way to increase spontaneous physical&#xD;
      activity (PA) in treated apneic obese patients with low spontaneous physical activity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 9, 2014</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2022</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in physical activity</measure>
    <time_frame>After a period of monthly supervised training program by neuromuscular electrical stimulation at home (12th wk)</time_frame>
    <description>Number of steps per day&#xD;
Number of METs per day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in body composition</measure>
    <time_frame>After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)</time_frame>
    <description>Fat mass and fat-mass index as assessed by impedancemetry measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in arterial stiffness</measure>
    <time_frame>After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)</time_frame>
    <description>Pulse wave velocity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in endothelial function</measure>
    <time_frame>After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )</time_frame>
    <description>Peripheral arterial tone (RH-PAT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasmatic biomarkers</measure>
    <time_frame>After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )</time_frame>
    <description>Oxidative stress and inflammatory blood parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )</time_frame>
    <description>SF-12 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cardiovascular events per year</measure>
    <time_frame>Every year from the 1st to the 2th year</time_frame>
    <description>Questionnaire sent to the patient by mail</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in other parameters of physical activity</measure>
    <time_frame>After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)</time_frame>
    <description>Energy expenditure (total and during daily activities)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality</measure>
    <time_frame>After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)</time_frame>
    <description>Lying and sleep duration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Obesity</condition>
  <condition>Number of Steps Per Day &lt; 7000</condition>
  <arm_group>
    <arm_group_label>Kneehab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 sessions per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>5 sessions per week</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation</intervention_name>
    <description>12 weeks : 5 sessions per week (1 supervised session at home every month)&#xD;
92 weeks : spontaneous training (supervised by phone every month)</description>
    <arm_group_label>Kneehab</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese patients with BMI &gt; 35 kg/m²&#xD;
&#xD;
          -  CPAP treatment and &gt; 4h observance per night to the patient with SAS&#xD;
&#xD;
          -  Patients who give written consent&#xD;
&#xD;
          -  Patients who subscribed social insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular or respiratory failure discovered at the moment of the inclusion in the&#xD;
             study&#xD;
&#xD;
          -  Contraindication to exercise&#xD;
&#xD;
          -  Pregnant or breast-feed woman&#xD;
&#xD;
          -  Patients under guardianship&#xD;
&#xD;
          -  Imprisoned patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renaud TAMISIER, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Universitaire de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital universitaire de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital universitaire de Saint Etienne</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>June 9, 2022</last_update_submitted>
  <last_update_submitted_qc>June 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT02210585
org study id: 38RC13.554
nct id: NCT02210585
lead sponsor: 
has dmc: Yes
The study was designed to test the following hypotheses:

      Main Objective:

      To compare the level of spontaneous physical activity at 3 months after re-entrainment by
      multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to
      conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation)
      (control arm).

      Secondary Objectives:

      To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical
      activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups.

      Design:

      We will conduct a multicenter controlled study vs. reference care with randomization into two
      parallel groups and double-blind (placebo electrostimulation). Patients will have the ES
      material available at home and will be supervised by monthly visits over 3 months and by
      telephone follow-up for two years. The study size calculation is based on physical activity,
      the percentage of lean body mass and arterial stiffness measured in the OBEX study.

      This project will determine whether the training strategy is effective for increasing
      physical activity and/or in inducing significant metabolic and cardiovascular effects in
      these patients after 2 years. In addition, it provides a solid base of investigation for the
      study of the interactions between muscle contraction and cardio-metabolic health with greater
      precision.
Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular
      risk. Furthermore, both diseases are associated with reduced exercise tolerance.

      For many patients with morbid obesity, the implementation of physical activity programs
      remains difficult for several reasons including the level of disability and psychosocial
      causes (the scrutiny of others, depression and poorly adapted equipment).

      Main hypothesis: Neuromuscular electrostimulation is a way to increase spontaneous physical
      activity (PA) in treated apneic obese patients with low spontaneous physical activity
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in physical activity
time frame: After a period of monthly supervised training program by neuromuscular electrical stimulation at home (12th wk)
description: Number of steps per day
Number of METs per day
measure: Changes in body composition
time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
description: Fat mass and fat-mass index as assessed by impedancemetry measurements
measure: Change in arterial stiffness
time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
description: Pulse wave velocity
measure: Change in endothelial function
time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
description: Peripheral arterial tone (RH-PAT)
measure: Change in plasmatic biomarkers
time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
description: Oxidative stress and inflammatory blood parameters
measure: Change in quality of life
time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
description: SF-12 questionnaire
measure: Number of cardiovascular events per year
time frame: Every year from the 1st to the 2th year
description: Questionnaire sent to the patient by mail
measure: Change in other parameters of physical activity
time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
description: Energy expenditure (total and during daily activities)
measure: Change in sleep quality
time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
description: Lying and sleep duration
arm group label: Kneehab
arm group type: Active Comparator
description: 5 sessions per week
arm group label: Placebo
arm group type: Placebo Comparator
description: 5 sessions per week
intervention type: Other
intervention name: Rehabilitation
description: 12 weeks : 5 sessions per week (1 supervised session at home every month)
92 weeks : spontaneous training (supervised by phone every month)
arm group label: Kneehab
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Renaud TAMISIER, Pr
role: Principal Investigator
affiliation: Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Obesity