<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/NCT03815708</url>
  </required_header>
  <id_info>
    <org_study_id>2018-24</org_study_id>
    <nct_id>NCT03815708</nct_id>
  </id_info>
  <brief_title>Heat Stress in Wheelchair Sports</brief_title>
  <official_title>Heat Stress During Wheelchair Rugby and Basketball</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Paraplegic Centre Nottwil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Paraplegic Centre Nottwil</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>
      The aim of the study is to study the thermoregulatory responses under real life conditions,&#xD;
      such as during wheelchair rugby and basketball matches. A further goal is to develop and&#xD;
      validate a standardised field-based protocol, which induces the same thermoregulatory&#xD;
      response as during a wheelchair rugby and basketball match. This knowledge allows to&#xD;
      investigate strategies to reduce heat stress and to enhance exercise performance (e.g.&#xD;
      pre-cooling) in the future, based on standardised conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A spinal cord injury leads to several physiological changes and complications, which might&#xD;
      influence exercise performance (Perret and Abel, 2016). One major problem is the limited&#xD;
      thermoregulation, especially in subjects suffering from a tetraplegia (Griggs et al., 2015;&#xD;
      Price et al., 2006). There are only few studies, which investigated the thermoregulatory&#xD;
      response during real life conditions in wheelchair athletes such as during a wheelchair rugby&#xD;
      match (Griggs et al., 2017). However, to implement strategies to reduce heat stress (e.g.&#xD;
      precooling methods) or to determine the influence of heat stress on exercise performance and&#xD;
      to determine the effects of specific interventions the following two issues seem to be a&#xD;
      prerequisite: First of all, we need to understand, which thermoregulatory response is induced&#xD;
      under real life conditions, e.g. by a wheelchair rugby or basketball match. Second, if we&#xD;
      want to study the effects of potential interventions, a standardised and reliable study&#xD;
      protocol has to be available, which closely mimics match conditions and induces a similar&#xD;
      amount of heat stress. Thus, the aim of the study is to measure thermoregulatory and physical&#xD;
      performance outcomes during a real life wheelchair rugby and basketball match. A further goal&#xD;
      is to develop and validate a standardised field-based protocol, which induces a similar&#xD;
      thermoregulatory response as during a wheelchair rugby or basketball match. These knowledge&#xD;
      builds the basis for future thermoregulatory studies based on a reliable and standardised&#xD;
      field-based testing protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body core temperature</measure>
    <time_frame>from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)</time_frame>
    <description>recording body core temperature with an electronic capsule from the beginning to the end of a rugby or basketball game</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)</time_frame>
    <description>heart rate from the beginning to the end of a rugby or basketball game</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>covered distance</measure>
    <time_frame>32 minutes (cohort 1) or 48 minutes (cohort 2)</time_frame>
    <description>covered distance (meters) during a rugby or basketball game</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>32 minutes (cohort 1) or 48 minutes (cohort 2)</time_frame>
    <description>difference in weight (kg) from before to after the game due to sweating and convection</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Heat Stress</condition>
  <condition>Body Temperature Changes</condition>
  <arm_group>
    <arm_group_label>wheelchair rugby players</arm_group_label>
    <description>well-trained spinal cord injured wheelchair rugby players</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wheelchair basketball players</arm_group_label>
    <description>well-trained spinal cord injured wheelchair basketball players</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        well trained spinal cord injured wheelchair rugby and basketball players&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent as documented by signature&#xD;
&#xD;
          -  healthy, male or female wheelchair rugby (with tetraplegia) or basketball player (with&#xD;
             paraplegia) of national or international level&#xD;
&#xD;
          -  regularly taking part in competitions/games&#xD;
&#xD;
          -  age between 18 and 60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  asthma&#xD;
&#xD;
          -  blood disorders&#xD;
&#xD;
          -  actual injury, which impairs performance or other impossibility to exercise to&#xD;
             exhaustion&#xD;
&#xD;
          -  cardiovascular disease&#xD;
&#xD;
          -  gastrointestinal disease, disorder or former surgery concerning the gastrointestinal&#xD;
             tract&#xD;
&#xD;
          -  not able to swallow a capsule&#xD;
&#xD;
          -  less than 40kg of body mass&#xD;
&#xD;
          -  MRI during the period of use of the e-Celsius® device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudio Perret, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swiss Paraplegic Centre, Guido A. Zäch Strasse 1, CH-6207 Nottwil</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Swiss Paraplegic Centre</name>
      <address>
        <city>Nottwil</city>
        <state>Lucerne</state>
        <zip>6207</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</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>Body Temperature Changes</mesh_term>
    <mesh_term>Heat Stress Disorders</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/NCT03815708
org study id: 2018-24
nct id: NCT03815708
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to study the thermoregulatory responses under real life conditions,
      such as during wheelchair rugby and basketball matches. A further goal is to develop and
      validate a standardised field-based protocol, which induces the same thermoregulatory
      response as during a wheelchair rugby and basketball match. This knowledge allows to
      investigate strategies to reduce heat stress and to enhance exercise performance (e.g.
      pre-cooling) in the future, based on standardised conditions.
A spinal cord injury leads to several physiological changes and complications, which might
      influence exercise performance (Perret and Abel, 2016). One major problem is the limited
      thermoregulation, especially in subjects suffering from a tetraplegia (Griggs et al., 2015;
      Price et al., 2006). There are only few studies, which investigated the thermoregulatory
      response during real life conditions in wheelchair athletes such as during a wheelchair rugby
      match (Griggs et al., 2017). However, to implement strategies to reduce heat stress (e.g.
      precooling methods) or to determine the influence of heat stress on exercise performance and
      to determine the effects of specific interventions the following two issues seem to be a
      prerequisite: First of all, we need to understand, which thermoregulatory response is induced
      under real life conditions, e.g. by a wheelchair rugby or basketball match. Second, if we
      want to study the effects of potential interventions, a standardised and reliable study
      protocol has to be available, which closely mimics match conditions and induces a similar
      amount of heat stress. Thus, the aim of the study is to measure thermoregulatory and physical
      performance outcomes during a real life wheelchair rugby and basketball match. A further goal
      is to develop and validate a standardised field-based protocol, which induces a similar
      thermoregulatory response as during a wheelchair rugby or basketball match. These knowledge
      builds the basis for future thermoregulatory studies based on a reliable and standardised
      field-based testing protocol.
observational model: Other
time perspective: Prospective
measure: Change in body core temperature
time frame: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)
description: recording body core temperature with an electronic capsule from the beginning to the end of a rugby or basketball game
measure: Change in heart rate
time frame: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)
description: heart rate from the beginning to the end of a rugby or basketball game
measure: covered distance
time frame: 32 minutes (cohort 1) or 48 minutes (cohort 2)
description: covered distance (meters) during a rugby or basketball game
measure: Change in body weight
time frame: 32 minutes (cohort 1) or 48 minutes (cohort 2)
description: difference in weight (kg) from before to after the game due to sweating and convection
arm group label: wheelchair rugby players
description: well-trained spinal cord injured wheelchair rugby players
arm group label: wheelchair basketball players
description: well-trained spinal cord injured wheelchair basketball players
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claudio Perret, PD Dr.
role: Principal Investigator
affiliation: Swiss Paraplegic Centre, Guido A. Zäch Strasse 1, CH-6207 Nottwil
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Body Temperature Changes
mesh term: Heat Stress Disorders
sharing ipd: No