<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/NCT03259932</url>
  </required_header>
  <id_info>
    <org_study_id>GREMEAUX PHRC I 2015</org_study_id>
    <nct_id>NCT03259932</nct_id>
  </id_info>
  <brief_title>Comparison of Fatigue and Recovery After Stroke Depending on the Usual Management With or Without Physical Training</brief_title>
  <acronym>FRAM</acronym>
  <official_title>Personalised Physical Training Associated With Usual Management Versus Usual Management Alone on Fatigue and Recovery After Minor Stroke: Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      After a minor stroke, patients frequently report complaints such as fatigue and difficulty&#xD;
      with certain everyday motor tasks, leading to a marked deterioration in their quality of&#xD;
      life. The aim of this study is to show that the implementation of a personalised physical&#xD;
      activity programme, starting 1 month after the hospitalisation for minor stroke,&#xD;
      significantly decreases the frequency of fatigue in these patients, in comparison with usual&#xD;
      management &quot;in real life&quot;..&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</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>Fatigue relief (assessed by the Fatigue Severity Scale)</measure>
    <time_frame>4 months after the stroke</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>usual management</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>physical training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no physical activity</intervention_name>
    <description>no physical activity</description>
    <arm_group_label>usual management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physical activity</intervention_name>
    <description>Rehabilitation program will start 4 weeks after discharge from acute care (S4), for a duration of 8 weeks (3 sessions / week). Physical training will include aerobic exercises 30-60 minutes at 50-80% of HRmax, associated with muscle building exercises in circuit training (20 min), and balance and flexibility exercises.</description>
    <arm_group_label>physical training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  National health insurance cover&#xD;
&#xD;
          -  1st minor ischaemic stroke (initial NIH score ≤ 4)&#xD;
&#xD;
          -  Satisfactory neurological recovery at discharge from hospital (modified Rankin score&#xD;
             ≤2)&#xD;
&#xD;
          -  Patient living close to the participating centre (&lt;50 km)&#xD;
&#xD;
          -  With early post-stroke fatigue (FFS score ≥ 4 at the definitive inclusion visit (W3))&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  haemorrhagic stroke&#xD;
&#xD;
          -  History of ischaemic or haemorrhagic stroke with clinical manifestations&#xD;
&#xD;
          -  History of TIA&#xD;
&#xD;
          -  MMS ≤ 24&#xD;
&#xD;
          -  Pre-existing dementia (defined according to DSM IV criteria)&#xD;
&#xD;
          -  Neurosensory or orthopaedic disorders requiring permanent technical support before the&#xD;
             stroke and making reconditioning impossible&#xD;
&#xD;
          -  Aggravation of the neurological status after the initial hospitalisation (NIH score ≥&#xD;
             6)&#xD;
&#xD;
          -  Recurrence of the cerebrovascular event or onset of an acute cardio-vascular event&#xD;
             between the screening and definitive inclusion&#xD;
&#xD;
          -  Pre-stroke Rankin score ≥ 3&#xD;
&#xD;
          -  Pregnant patient&#xD;
&#xD;
          -  Patient under guardianship&#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_contact>
    <last_name>Vincent GREMEAUX, MD</last_name>
    <phone>3.80.29.38.15</phone>
    <phone_ext>+33</phone_ext>
    <email>vincent.gremeaux@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Loic FOUCHER, MD</last_name>
      <phone>3.80.29.33.71</phone>
      <phone_ext>+33</phone_ext>
      <email>loic.foucher@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</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>Stroke</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/NCT03259932
org study id: GREMEAUX PHRC I 2015
nct id: NCT03259932
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
After a minor stroke, patients frequently report complaints such as fatigue and difficulty
      with certain everyday motor tasks, leading to a marked deterioration in their quality of
      life. The aim of this study is to show that the implementation of a personalised physical
      activity programme, starting 1 month after the hospitalisation for minor stroke,
      significantly decreases the frequency of fatigue in these patients, in comparison with usual
      management "in real life"..
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fatigue relief (assessed by the Fatigue Severity Scale)
time frame: 4 months after the stroke
arm group label: usual management
arm group type: Other
arm group label: physical training
arm group type: Experimental
intervention type: Other
intervention name: no physical activity
description: no physical activity
arm group label: usual management
intervention type: Other
intervention name: physical activity
description: Rehabilitation program will start 4 weeks after discharge from acute care (S4), for a duration of 8 weeks (3 sessions / week). Physical training will include aerobic exercises 30-60 minutes at 50-80% of HRmax, associated with muscle building exercises in circuit training (20 min), and balance and flexibility exercises.
arm group label: physical training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vincent GREMEAUX, MD
phone: 3.80.29.38.15
phone ext: +33
email: vincent.gremeaux@chu-dijon.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Stroke