<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/NCT03785483</url>
  </required_header>
  <id_info>
    <org_study_id>apsep-01</org_study_id>
    <nct_id>NCT03785483</nct_id>
  </id_info>
  <brief_title>Implementation Intention for Physical Activity in Multiple Sclerosis</brief_title>
  <acronym>apsep</acronym>
  <official_title>Controlled Trial Testing the Effectiveness of Motivational Support on Physical Activity and Fatigue of Patients With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Paris 5 - Rene Descartes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CeRSM</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>COMUE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Poissy-Saint Germain Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Raymond Poincaré</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Paris West University Nanterre La Défense</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cite Sep</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Paris 5 - Rene Descartes</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>
      The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on&#xD;
      implementation intention (motivation) in patients with multiple sclerosis on objectively&#xD;
      measured physical activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">December 30, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>3 groups: motivation, mindfulness, and treatment as usual</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in physical activity</measure>
    <time_frame>From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.</time_frame>
    <description>Accelerometer on a daily basis for 7 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported anxiety and depression (HADS)</measure>
    <time_frame>From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.</time_frame>
    <description>Hospital Anxiety and Depression Scale (2 subscales): anxiety (7 items) and depression (7 items) rated on a Likert-type scale ranging from 0 to 3. Total score for each subscale is the sum of each subscale's items. Higher scores indicate higher risks of anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported mindfulness skills (FFMQ)</measure>
    <time_frame>From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.</time_frame>
    <description>Five-Facets Mindfulness Questionnaire (5 subscales): observing, describing, non-judging, non-reacting, acting with awareness. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 5. Total score for each subscale is the sum of each subscale's items. Total mindfulness score is the sum of all subscales' scores. Higher scores indicate higher mindfulness skills.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported motivational regulation toward exercise (BREQ)</measure>
    <time_frame>From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.</time_frame>
    <description>Behavioral Regulation in Exercise Questionnaire (6 subscales): amotivation, external regulation, introjected regulation, integrated regulation, identified regulation, intrinsic regulation. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher motivational regulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported beliefs toward physical activity (TPB).</measure>
    <time_frame>From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.</time_frame>
    <description>Theory of Planned Behavior constructs (4 concepts): attitudes (5 items), subjective norm (4 items), perceived behavioral control (2 items), intentions (3 items). All items are rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher beliefs toward physical activity/</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Motivation</condition>
  <condition>Mindfulness</condition>
  <arm_group>
    <arm_group_label>Motivation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using implementation intention techniques such as action planning. Every week, participants state when, where, and what kind of prescribed exercises they will do.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 minutes of audio recordings daily. Recordings contain: awareness of the breath, acceptation of thoughts and emotions, awareness of postures, awareness during stretching, awareness of a single movement (moving legs up while standing).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Physical activity prescribe 120 minutes per week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivation</intervention_name>
    <description>8 weeks of either action planning or mindfulness in addition to a treatment as usual which is a physical activity program of 120 minutes per week.</description>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_label>Motivation</arm_group_label>
    <other_name>Mindfulness</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult aged between 18 and 65 years&#xD;
&#xD;
          -  Multiple sclerosis&#xD;
&#xD;
          -  Recruited from CHU Poissy saint germain or Hôpital Raymond-Poincaré&#xD;
&#xD;
          -  Informed consent provided during inclusion interview&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already participating in a clinical trial&#xD;
&#xD;
          -  Cognitive dysfunctions in understanding simple guidelines&#xD;
&#xD;
          -  Treatment reducing fatigue since less than 3 months&#xD;
&#xD;
          -  Psychiatric disorders&#xD;
&#xD;
          -  Unability to exercise&#xD;
&#xD;
          -  Previous cardiovascular diseases&#xD;
&#xD;
          -  Regular physical activity practice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emilie Dematte, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Paris Nanterre University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Giovanni De Marco, Pr</last_name>
    <phone>0033140975755</phone>
    <email>demarco.giovanni@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jean F Fournier, PhD</last_name>
    <phone>0033140975639</phone>
    <email>jean.fournier@u-paris10.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Raymond-Poincaré</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emilie Dematte, MSc</last_name>
      <email>emilie.dematte@wanadoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Poissy Saint germain</name>
      <address>
        <city>Poissy</city>
        <zip>78300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emilie Dematte, MSc</last_name>
      <email>emilie.dematte@wanadoo.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 22, 2018</last_update_submitted>
  <last_update_submitted_qc>December 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Paris 5 - Rene Descartes</investigator_affiliation>
    <investigator_full_name>Ruffault Alexis</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Multiple sclerosis</keyword>
  <keyword>Motivation</keyword>
  <keyword>Intention</keyword>
  <keyword>Mindfulness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</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/NCT03785483
org study id: apsep-01
nct id: NCT03785483
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on
      implementation intention (motivation) in patients with multiple sclerosis on objectively
      measured physical activity.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 3 groups: motivation, mindfulness, and treatment as usual
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in physical activity
time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
description: Accelerometer on a daily basis for 7 days
measure: Change in self-reported anxiety and depression (HADS)
time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
description: Hospital Anxiety and Depression Scale (2 subscales): anxiety (7 items) and depression (7 items) rated on a Likert-type scale ranging from 0 to 3. Total score for each subscale is the sum of each subscale's items. Higher scores indicate higher risks of anxiety and depression.
measure: Change in self-reported mindfulness skills (FFMQ)
time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
description: Five-Facets Mindfulness Questionnaire (5 subscales): observing, describing, non-judging, non-reacting, acting with awareness. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 5. Total score for each subscale is the sum of each subscale's items. Total mindfulness score is the sum of all subscales' scores. Higher scores indicate higher mindfulness skills.
measure: Change in self-reported motivational regulation toward exercise (BREQ)
time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
description: Behavioral Regulation in Exercise Questionnaire (6 subscales): amotivation, external regulation, introjected regulation, integrated regulation, identified regulation, intrinsic regulation. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher motivational regulation.
measure: Change in self-reported beliefs toward physical activity (TPB).
time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
description: Theory of Planned Behavior constructs (4 concepts): attitudes (5 items), subjective norm (4 items), perceived behavioral control (2 items), intentions (3 items). All items are rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher beliefs toward physical activity/
arm group label: Motivation
arm group type: Experimental
description: Using implementation intention techniques such as action planning. Every week, participants state when, where, and what kind of prescribed exercises they will do.
arm group label: Mindfulness
arm group type: Active Comparator
description: 10 minutes of audio recordings daily. Recordings contain: awareness of the breath, acceptation of thoughts and emotions, awareness of postures, awareness during stretching, awareness of a single movement (moving legs up while standing).
arm group label: Treatment as usual
arm group type: No Intervention
description: Physical activity prescribe 120 minutes per week.
intervention type: Behavioral
intervention name: Motivation
description: 8 weeks of either action planning or mindfulness in addition to a treatment as usual which is a physical activity program of 120 minutes per week.
arm group label: Mindfulness
arm group label: Motivation
other name: Mindfulness
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Emilie Dematte, MSc
role: Principal Investigator
affiliation: Paris Nanterre University
last name: Giovanni De Marco, Pr
phone: 0033140975755
email: demarco.giovanni@gmail.com
last name: Jean F Fournier, PhD
phone: 0033140975639
email: jean.fournier@u-paris10.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: University of Paris 5 - Rene Descartes
investigator full name: Ruffault Alexis
investigator title: PhD
mesh term: Multiple Sclerosis
mesh term: Sclerosis