<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/NCT01718392</url>
  </required_header>
  <id_info>
    <org_study_id>CME 2011/311</org_study_id>
    <nct_id>NCT01718392</nct_id>
  </id_info>
  <brief_title>Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      the purpose of this study is to investigate the development of insulin resistance in multiple&#xD;
      sclerosis patients + explaining the effects of a combined training programme on insulin&#xD;
      resistance, muscle power and aerobic capacity in multiple sclerosis patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>insulin sensitivity (insulin profile)</measure>
    <time_frame>change from baseline to 24 weeks</time_frame>
    <description>glucose and insulin concentration measurements in blood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>aerobic capacity</measure>
    <time_frame>change from baseline to 24 weeks</time_frame>
    <description>by means of a submaximal endurance test (ergometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>aerobic capacity - lactate concentrations</measure>
    <time_frame>change from baseline to 24 weeks</time_frame>
    <description>by means of a submaximal endurance test (ergometer) to determine lactate concentrations (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cytokine profile</measure>
    <time_frame>change from baseline to 24 weeks</time_frame>
    <description>measurements of blood cytokine levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>walking performance</measure>
    <time_frame>change from baseline to 24 weeks</time_frame>
    <description>Walking performance will be assessed by means of 2 and 6 minute walk test, 25-foot walk test, Chair rise test, Stair climb test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported measures</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>The self-reported measures contains some questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body composition</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>Weight, body fat% and lean tissue% will be assessed by means of a DEXA (Dual-energy X-ray absorptiometry) scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle strength of knee flexor</measure>
    <time_frame>change from baseline to 24 weeks</time_frame>
    <description>by means of an isokinetic dynamometer the muscle strength and endurance will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle strength of knee extensor</measure>
    <time_frame>change from baseline to 24 weeks</time_frame>
    <description>by means of an isokinetic dynamometer the muscle strength and endurance will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle strength of elbow flexor</measure>
    <time_frame>change from baseline to 24 weeks</time_frame>
    <description>by means of an isokinetic dynamometer the muscle strength will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle strength of elbow extensor</measure>
    <time_frame>change from baseline to 24 weeks</time_frame>
    <description>by means of an isokinetic dynamometer the muscle strength will be measured</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 weeks combined exercise programme (supervised)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>sedentary/habitual lifestyle</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training</intervention_name>
    <arm_group_label>Training</arm_group_label>
    <other_name>24 weeks combined exercise programma (supervised)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed MS according to the McDonald criteria&#xD;
&#xD;
          -  Expanded Disability Status Scale (EDSS) between 0.5 and 6&#xD;
&#xD;
          -  Be able to train 5 times in 2 weeks at the University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases&#xD;
             (like diabetes type 2)&#xD;
&#xD;
          -  Having had an relapse in a period of 3 months prior to the start of the intervention&#xD;
             period&#xD;
&#xD;
          -  Having an relapse during the intervention period&#xD;
&#xD;
          -  Pregnancy and other contra indications for physical activity&#xD;
&#xD;
          -  Mental disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Inez Wens, M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Reval/Biomed, Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bert Op't Eijnde, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Reval/Biomed, Hasselt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>REVAL</name>
      <address>
        <city>Diepenbeek</city>
        <zip>3590</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>Bert Op't Eijnde</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>combined training</keyword>
  <keyword>insulin resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Sclerosis</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/NCT01718392
org study id: CME 2011/311
nct id: NCT01718392
lead sponsor: 
has dmc: Yes
the purpose of this study is to investigate the development of insulin resistance in multiple
      sclerosis patients + explaining the effects of a combined training programme on insulin
      resistance, muscle power and aerobic capacity in multiple sclerosis patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: insulin sensitivity (insulin profile)
time frame: change from baseline to 24 weeks
description: glucose and insulin concentration measurements in blood
measure: aerobic capacity
time frame: change from baseline to 24 weeks
description: by means of a submaximal endurance test (ergometer)
measure: aerobic capacity - lactate concentrations
time frame: change from baseline to 24 weeks
description: by means of a submaximal endurance test (ergometer) to determine lactate concentrations (mmol/L)
measure: cytokine profile
time frame: change from baseline to 24 weeks
description: measurements of blood cytokine levels
measure: walking performance
time frame: change from baseline to 24 weeks
description: Walking performance will be assessed by means of 2 and 6 minute walk test, 25-foot walk test, Chair rise test, Stair climb test
measure: Self-reported measures
time frame: Change from baseline to 24 weeks
description: The self-reported measures contains some questionnaires
measure: body composition
time frame: Change from baseline to 24 weeks
description: Weight, body fat% and lean tissue% will be assessed by means of a DEXA (Dual-energy X-ray absorptiometry) scan
measure: muscle strength of knee flexor
time frame: change from baseline to 24 weeks
description: by means of an isokinetic dynamometer the muscle strength and endurance will be measured
measure: muscle strength of knee extensor
time frame: change from baseline to 24 weeks
description: by means of an isokinetic dynamometer the muscle strength and endurance will be measured
measure: muscle strength of elbow flexor
time frame: change from baseline to 24 weeks
description: by means of an isokinetic dynamometer the muscle strength will be measured
measure: muscle strength of elbow extensor
time frame: change from baseline to 24 weeks
description: by means of an isokinetic dynamometer the muscle strength will be measured
arm group label: Training
arm group type: Experimental
description: 24 weeks combined exercise programme (supervised)
arm group label: Control
arm group type: No Intervention
description: sedentary/habitual lifestyle
intervention type: Behavioral
intervention name: Training
arm group label: Training
other name: 24 weeks combined exercise programma (supervised)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Inez Wens, M.Sc.
role: Principal Investigator
affiliation: Reval/Biomed, Hasselt University
last name: Bert Op't Eijnde, Ph.D.
role: Study Chair
affiliation: Reval/Biomed, Hasselt University
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Bert Op't Eijnde
investigator title: Professor
mesh term: Multiple Sclerosis
mesh term: Insulin Resistance
mesh term: Sclerosis