xml: <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/NCT06021834</url>
    </required_header>
    <id_info>
      <org_study_id>Faculté de Médecine de Sousse</org_study_id>
      <nct_id>NCT06021834</nct_id>
    </id_info>
    <brief_title>Effect of Physical Rehabilitation in Patients With Parkinson's Disease</brief_title>
    <official_title>Effect of Physical Rehabilitation on Cardiorespiratory Parameters, Postural Balance and Sociopsychological and Cognitive Variables in Patients With Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Faculty of Medicine, Sousse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Faculty of Medicine, Sousse</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This is a prospective study. The aim of this study is to investigate the effect of exercise&#xD;
        retraining on cardiorespiratory parameters, postural balance, sociopsychological variables,&#xD;
        and cognitive function in subjects with Parkinson's disease.&#xD;
  &#xD;
        There will be two measurement sessions, one pre-intervention and one post-intervention&#xD;
        (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and&#xD;
        assessing cognitive function).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        this is a 12-week prospective study with the theme that I wish to develop in this context&#xD;
        entitled &quot;the effect of exercise retraining on cardiorespiratory parameters, postural&#xD;
        balance, sociopsychological variables, and cognitive function in subjects with Parkinson's&#xD;
        disease&quot;.&#xD;
  &#xD;
        There will be two measurement sessions, one pre-intervention and one post-intervention&#xD;
        (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and&#xD;
        assessing cognitive function).&#xD;
  &#xD;
        The recruited subjects will be randomly assigned to two groups: a control group and an&#xD;
        experimental group. The subjects will be invited to attend the program three times per week.&#xD;
  &#xD;
        The control group will engage in an endurance training program, while the experimental group&#xD;
        will participate in a combined endurance training and cognitive training program&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 8, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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 (Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cardiorespiratory Parameters</measure>
      <time_frame>There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)</time_frame>
      <description>Cardiorespiratory Parameters will be assessed using the six-minute walk test (6MWT).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postural Balance</measure>
      <time_frame>There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)</time_frame>
      <description>Postural balance will be assessed using the Timed Up and Go test (TUG) and stabilometry platform</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depression</measure>
      <time_frame>There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)</time_frame>
      <description>The depression variable will be assessed through Beck Depression Inventory-II .</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Function</measure>
      <time_frame>There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)</time_frame>
      <description>Cognitive function will be evaluated using the Montreal Cognitive Assessment score (MoCA) .</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Strength</measure>
      <time_frame>There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)</time_frame>
      <description>handgrip test, Functional Reach Test, Five time to sit and stand test</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control group will be invited to attend the program three times per week and will engage in an endurance training program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>the experimental group will be invited to attend the program three times per week and will participate in a combined endurance training and cognitive training program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>rehabilitation</intervention_name>
      <description>The subjects will be invited to attend the program three times per week.</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with Parkinson's disease according to the Movement Disorder Society (MDS)&#xD;
               2015 criteria.&#xD;
  &#xD;
            -  Mild to moderate stage according to the Hoehn and Yahr scale.&#xD;
  &#xD;
            -  No hearing or visual impairments that could hinder the integration and implementation&#xD;
               of the rehabilitation protocol.&#xD;
  &#xD;
            -  Has the ability to communicate and walk.&#xD;
  &#xD;
            -  Patient has been stable on treatment for 3 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A contraindication to engaging in cardiovascular physical activity&#xD;
  &#xD;
            -  A Montreal Cognitive Assessment score (MoCA ) of less than 24.&#xD;
  &#xD;
            -  A current psychiatric disorder that could make it difficult or dangerous to adhere to&#xD;
               the research protocol.&#xD;
  &#xD;
            -  Musculoskeletal impairments or excessive pain in any joint that could limit&#xD;
               participation in an exercise program.&#xD;
  &#xD;
            -  Treatment with sedative medications&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Faculty of Medicine, Sousse</investigator_affiliation>
      <investigator_full_name>Ghazoua Nafti</investigator_full_name>
      <investigator_title>Principal Investigator Ghazoua NAFTI</investigator_title>
    </responsible_party>
    <keyword>&quot;Parkinson Disease&quot;</keyword>
    <keyword>&quot;cognitive function&quot;</keyword>
    <keyword>&quot;postural balance&quot;</keyword>
    <keyword>&quot;physical rehabilitation&quot;</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021834
  org study id: Faculté de Médecine de Sousse
  nct id: NCT06021834
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective study. The aim of this study is to investigate the effect of exercise
        retraining on cardiorespiratory parameters, postural balance, sociopsychological variables,
        and cognitive function in subjects with Parkinson's disease.
  
        There will be two measurement sessions, one pre-intervention and one post-intervention
        (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and
        assessing cognitive function).
  this is a 12-week prospective study with the theme that I wish to develop in this context
        entitled "the effect of exercise retraining on cardiorespiratory parameters, postural
        balance, sociopsychological variables, and cognitive function in subjects with Parkinson's
        disease".
  
        There will be two measurement sessions, one pre-intervention and one post-intervention
        (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and
        assessing cognitive function).
  
        The recruited subjects will be randomly assigned to two groups: a control group and an
        experimental group. The subjects will be invited to attend the program three times per week.
  
        The control group will engage in an endurance training program, while the experimental group
        will participate in a combined endurance training and cognitive training program
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Care Provider)
  measure: Cardiorespiratory Parameters
  time frame: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
  description: Cardiorespiratory Parameters will be assessed using the six-minute walk test (6MWT).
  measure: Postural Balance
  time frame: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
  description: Postural balance will be assessed using the Timed Up and Go test (TUG) and stabilometry platform
  measure: Depression
  time frame: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
  description: The depression variable will be assessed through Beck Depression Inventory-II .
  measure: Cognitive Function
  time frame: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
  description: Cognitive function will be evaluated using the Montreal Cognitive Assessment score (MoCA) .
  measure: Strength
  time frame: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
  description: handgrip test, Functional Reach Test, Five time to sit and stand test
  arm group label: control group
  arm group type: Active Comparator
  description: The control group will be invited to attend the program three times per week and will engage in an endurance training program
  arm group label: experimental group
  arm group type: Experimental
  description: the experimental group will be invited to attend the program three times per week and will participate in a combined endurance training and cognitive training program.
  intervention type: Other
  intervention name: rehabilitation
  description: The subjects will be invited to attend the program three times per week.
  arm group label: control group
  arm group label: experimental group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Faculty of Medicine, Sousse
  investigator full name: Ghazoua Nafti
  investigator title: Principal Investigator Ghazoua NAFTI
  mesh term: Parkinson Disease