<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/NCT03244813</url>
  </required_header>
  <id_info>
    <org_study_id>NIMAO/2016/EV-01</org_study_id>
    <nct_id>NCT03244813</nct_id>
  </id_info>
  <brief_title>Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease</brief_title>
  <acronym>ACTIPARK</acronym>
  <official_title>Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our study aims to compare the effects of a standard care plan to one using adapted physical&#xD;
      activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will&#xD;
      allow the collection of quantitative and objective data related to activity in contrast to&#xD;
      questionnaires which are more subjective and dependent on self-representation. In addition,&#xD;
      the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide&#xD;
      interesting data from this population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">December 2, 2019</completion_date>
  <primary_completion_date type="Actual">December 2, 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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The medical team assessing patient functional capacities and caregiver burden at 3 and 6 months will not know which treatment the patient received</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease</measure>
    <time_frame>3 months</time_frame>
    <description>previous weeks' activity measured by actigraphy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activity of patients in both groups</measure>
    <time_frame>6 months</time_frame>
    <description>previous weeks' activity measured by actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of patients in both groups</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by international physical activity questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of patients undertaking APA verses standard care</measure>
    <time_frame>3 months</time_frame>
    <description>Assessed by PDG-39 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of patients undertaking APA verses standard care</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed by PDG-39 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of fall of patients undertaking APA verses standard care</measure>
    <time_frame>3 months</time_frame>
    <description>measured by Timed Up and Go test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of fall of patients undertaking APA verses standard care</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Timed Up and Go test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of fall of patients undertaking APA verses standard care</measure>
    <time_frame>3 months</time_frame>
    <description>measured by Tinetti Falls Efficacy Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of fall of patients undertaking APA verses standard care</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Tinetti Falls Efficacy Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of fall of patients undertaking APA verses standard care</measure>
    <time_frame>3 months</time_frame>
    <description>measured by 0-10 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of fall of patients undertaking APA verses standard care</measure>
    <time_frame>6 months</time_frame>
    <description>measured by 0-10 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endurance and speed of walking of patients undertaking APA verses standard care</measure>
    <time_frame>3 months</time_frame>
    <description>6 minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endurance and speed of walking of patients undertaking APA verses standard care</measure>
    <time_frame>6 months</time_frame>
    <description>6 minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of the care giver</measure>
    <time_frame>3 months</time_frame>
    <description>previous weeks' activity measured by actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of the care giver</measure>
    <time_frame>6 months</time_frame>
    <description>previous weeks' activity measured by actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the care burden of care giver</measure>
    <time_frame>3 months</time_frame>
    <description>Zarit scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the care burden of care giver</measure>
    <time_frame>6 months</time_frame>
    <description>Zarit scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>Day 0</time_frame>
    <description>Pinch test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>6 months</time_frame>
    <description>Pinch test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient dependence</measure>
    <time_frame>Day 0</time_frame>
    <description>Activities of Daily Living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient dependence</measure>
    <time_frame>6 months</time_frame>
    <description>Activities of Daily Living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of dementia at Day</measure>
    <time_frame>Day 0</time_frame>
    <description>Instrumental Activities of Daily Living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of dementia at Day</measure>
    <time_frame>6 months</time_frame>
    <description>Instrumental Activities of Daily Living</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Adapted physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personalized activity program</intervention_name>
    <description>Targeted physical activity</description>
    <arm_group_label>Adapted physical activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient and their carer have given their free and informed consent and signed the&#xD;
             consent form&#xD;
&#xD;
          -  The patient must be insured of the beneficiary of an insurance policy&#xD;
&#xD;
          -  The patient is available for the 6 month follow-up&#xD;
&#xD;
          -  The patient is between 40 and 80 years old&#xD;
&#xD;
          -  The patient has experienced symptoms of Parkinson Disease for at least 5 years and is&#xD;
             in a stable state (no medical event or change of treatment in at least 1 month)&#xD;
&#xD;
          -  The functional impact and duration of fluctuations is ≥3 (MDS UPDRS)&#xD;
&#xD;
          -  The patient can walk autonomously, including using a technical aid&#xD;
&#xD;
          -  The patient does not have any regular physical activity excluding physiotherapy&#xD;
             sessions&#xD;
&#xD;
          -  The patient has daily help from a caregiver&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject and/or their caregiver is participating in another study&#xD;
&#xD;
          -  The subject and/or their caregiver is in a period of exclusion determined by a&#xD;
             previous study&#xD;
&#xD;
          -  The patients is under judicial protection or state guardianship&#xD;
&#xD;
          -  It proves impossible to give the patient and/or the caregiver clear information&#xD;
&#xD;
          -  The patients and/or the caregiver reuses to sign the consent form&#xD;
&#xD;
          -  The patient is pregnant or breast feeding&#xD;
&#xD;
          -  The patient has anxiety or depression (Score HAD≥ 11/14), cardiac or respiratory&#xD;
             failure (stress test), vesico-sphincter problems preventing normal practice of a&#xD;
             physical activity, a contraindication to adapted physical activities&#xD;
&#xD;
          -  The patient cannot walk&#xD;
&#xD;
          -  Muscular tremor preventing the actigraphy measurement. Outside normal range values for&#xD;
             UPDRS measures of: 3.15) postural tremor of the hands; 3.16) action tremor of the&#xD;
             hands; 3.17) amplitude of rest tremor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Nimes</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>June 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>January 23, 2020</last_update_submitted>
  <last_update_submitted_qc>January 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</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>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03244813
org study id: NIMAO/2016/EV-01
nct id: NCT03244813
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our study aims to compare the effects of a standard care plan to one using adapted physical
      activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will
      allow the collection of quantitative and objective data related to activity in contrast to
      questionnaires which are more subjective and dependent on self-representation. In addition,
      the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide
      interesting data from this population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: The medical team assessing patient functional capacities and caregiver burden at 3 and 6 months will not know which treatment the patient received
measure: Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease
time frame: 3 months
description: previous weeks' activity measured by actigraphy
measure: Activity of patients in both groups
time frame: 6 months
description: previous weeks' activity measured by actigraphy
measure: Activity of patients in both groups
time frame: 6 months
description: assessed by international physical activity questionnaire
measure: Quality of life of patients undertaking APA verses standard care
time frame: 3 months
description: Assessed by PDG-39 questionnaire
measure: Quality of life of patients undertaking APA verses standard care
time frame: 6 months
description: Assessed by PDG-39 questionnaire
measure: Risk of fall of patients undertaking APA verses standard care
time frame: 3 months
description: measured by Timed Up and Go test
measure: Risk of fall of patients undertaking APA verses standard care
time frame: 6 months
description: measured by Timed Up and Go test
measure: Risk of fall of patients undertaking APA verses standard care
time frame: 3 months
description: measured by Tinetti Falls Efficacy Scale
measure: Risk of fall of patients undertaking APA verses standard care
time frame: 6 months
description: measured by Tinetti Falls Efficacy Scale
measure: Risk of fall of patients undertaking APA verses standard care
time frame: 3 months
description: measured by 0-10 scale
measure: Risk of fall of patients undertaking APA verses standard care
time frame: 6 months
description: measured by 0-10 scale
measure: Endurance and speed of walking of patients undertaking APA verses standard care
time frame: 3 months
description: 6 minute walk test
measure: Endurance and speed of walking of patients undertaking APA verses standard care
time frame: 6 months
description: 6 minute walk test
measure: Activity of the care giver
time frame: 3 months
description: previous weeks' activity measured by actigraphy
measure: Activity of the care giver
time frame: 6 months
description: previous weeks' activity measured by actigraphy
measure: Evaluation of the care burden of care giver
time frame: 3 months
description: Zarit scale
measure: Evaluation of the care burden of care giver
time frame: 6 months
description: Zarit scale
measure: Grip strength
time frame: Day 0
description: Pinch test
measure: Grip strength
time frame: 6 months
description: Pinch test
measure: Patient dependence
time frame: Day 0
description: Activities of Daily Living
measure: Patient dependence
time frame: 6 months
description: Activities of Daily Living
measure: Level of dementia at Day
time frame: Day 0
description: Instrumental Activities of Daily Living
measure: Level of dementia at Day
time frame: 6 months
description: Instrumental Activities of Daily Living
arm group label: Adapted physical activity
arm group type: Experimental
arm group label: Standard care
arm group type: No Intervention
intervention type: Other
intervention name: Personalized activity program
description: Targeted physical activity
arm group label: Adapted physical activity
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No