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/NCT06040450</url>
    </required_header>
    <id_info>
      <org_study_id>2023-004</org_study_id>
      <nct_id>NCT06040450</nct_id>
    </id_info>
    <brief_title>The Impact of Outdoor Sports Practice on the Well-Being of Disabled People</brief_title>
    <official_title>The Impact of Outdoor Sports Practice on the Well-Being of Disabled People : a Cross-Sectional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut de Sante Parasport Connecte Synergies</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fédération Française Handisport (FFH)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Université de Montpellier - UMR Santé, Education et Situations de Handicap (SANTESIH)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Institut de Sante Parasport Connecte Synergies</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>
        Survey of the members of the French Handisports Federation (FFH) practicing outdoor sports.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a national cross-sectional study to investigate the impact of outdoor sports practice&#xD;
        on the well-being and self-esteem of people with disabilities.&#xD;
  &#xD;
        The study is based on a survey of FFH members practicing outdoor sports. The survey will be&#xD;
        distributed between October and November 2023 via the federation's internal communication&#xD;
        system. Data will be collected on outdoor sports activity, psychological impact and barriers&#xD;
        to practice.&#xD;
  &#xD;
        Analyses will be made between able-bodied and disabled members, between types of disability,&#xD;
        and between types of outdoor sport practiced (water, land and air).&#xD;
  &#xD;
        Analysis will be based on anomysed data and will respect the MR004 methodology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Impact of my outdoor sports on my well-being</measure>
      <time_frame>Baseline</time_frame>
      <description>Rating Scale : 1 (low) to 10 (high)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Impact of my outdoor sports on my self-esteem</measure>
      <time_frame>Baseline</time_frame>
      <description>Rating Scale : 1 (low) to 10 (high)</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Disability or Chronic Disease Leading to Disablement</condition>
    <arm_group>
      <arm_group_label>All subjects with impairments</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>All subjects without impairments</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire survey</intervention_name>
      <description>On outdoor sports practice activity, barriers to practice, impacts on well-being.</description>
      <arm_group_label>All subjects with impairments</arm_group_label>
      <arm_group_label>All subjects without impairments</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Members of the French Handisport Federation practicing outdoor sports&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being a member of the French Handisport Federation between September 2022 and August&#xD;
               2023&#xD;
  &#xD;
            -  Practicing outdoor sports&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Persons who have objected to be contacted by e-mail&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vincent T. Carpentier, MD-MSc</last_name>
      <role>Study Director</role>
      <affiliation>Institut de Sante Parasport Connecte Synergies</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Eric Perera, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Montpellier University - SANTESIH</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Emmanuel Buchoud</last_name>
      <role>Study Director</role>
      <affiliation>French Handisport Federation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vincent T. Carpentier, MD-MSc</last_name>
      <phone>+33 1 47 10 70 82</phone>
      <email>vincent.carpentier@ispc-synergies.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>French Handisport Federation</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Emmanuel Buchoud</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Physical activities, Outdoor sports, Disability</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic 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>
  
  
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/NCT06040450
  org study id: 2023-004
  nct id: NCT06040450
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Survey of the members of the French Handisports Federation (FFH) practicing outdoor sports.
  This is a national cross-sectional study to investigate the impact of outdoor sports practice
        on the well-being and self-esteem of people with disabilities.
  
        The study is based on a survey of FFH members practicing outdoor sports. The survey will be
        distributed between October and November 2023 via the federation's internal communication
        system. Data will be collected on outdoor sports activity, psychological impact and barriers
        to practice.
  
        Analyses will be made between able-bodied and disabled members, between types of disability,
        and between types of outdoor sport practiced (water, land and air).
  
        Analysis will be based on anomysed data and will respect the MR004 methodology.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Impact of my outdoor sports on my well-being
  time frame: Baseline
  description: Rating Scale : 1 (low) to 10 (high)
  measure: Impact of my outdoor sports on my self-esteem
  time frame: Baseline
  description: Rating Scale : 1 (low) to 10 (high)
  arm group label: All subjects with impairments
  arm group label: All subjects without impairments
  intervention type: Other
  intervention name: Questionnaire survey
  description: On outdoor sports practice activity, barriers to practice, impacts on well-being.
  arm group label: All subjects with impairments
  arm group label: All subjects without impairments
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Vincent T. Carpentier, MD-MSc
  role: Study Director
  affiliation: Institut de Sante Parasport Connecte Synergies
  last name: Eric Perera, PhD
  role: Study Director
  affiliation: Montpellier University - SANTESIH
  last name: Emmanuel Buchoud
  role: Study Director
  affiliation: French Handisport Federation
  last name: Vincent T. Carpentier, MD-MSc
  phone: +33 1 47 10 70 82
  email: vincent.carpentier@ispc-synergies.org
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Chronic Disease
  sharing ipd: No