<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/NCT04460339</url>
  </required_header>
  <id_info>
    <org_study_id>THERMO25</org_study_id>
    <nct_id>NCT04460339</nct_id>
  </id_info>
  <brief_title>Thermoregulation During a 25-km Open Water Race</brief_title>
  <acronym>THERMO25</acronym>
  <official_title>Changes in Body Core Temperature During a 25-km Open Water Race in Elite Swimmers: Identifying Predictors for Hypothermia and Dropouts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</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>
      Open water swimming is a swimming discipline which takes place in outdoor water such as open&#xD;
      oceans, lakes, and rivers. Elite swimmers are exposed to hypothermia when swimming in cold&#xD;
      water, especially in long duration races, such as the 25-km race. The objective of this study&#xD;
      is to evaluate the change in body core temperature in swimmers with continuous temperature&#xD;
      monitoring during a 25-km race. The secondary objective is to identify the predictors of&#xD;
      hypothermia and hypothermia-related drop-out.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">June 3, 2020</completion_date>
  <primary_completion_date type="Actual">May 26, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Core Temperature</measure>
    <time_frame>Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer</time_frame>
    <description>Measurement of Body Core Temperature using an ingestible electronic sensor (e-Celsius®, BodyCap , Caen, France) which provide a continuous validated measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Water Temperature</measure>
    <time_frame>Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer</time_frame>
    <description>Measurement of the Water Temperature using an electronic sensor (iButton® Maxim Integrated) which provide a continuous validated measurement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition, body mass</measure>
    <time_frame>One measurement assessed the day before the race</time_frame>
    <description>Body mass (in kg) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition, fat mass</measure>
    <time_frame>One measurement assessed the day before the race</time_frame>
    <description>Fat mass (in kg, % of body mass [fat mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition, fat-free mass</measure>
    <time_frame>One measurement assessed the day before the race</time_frame>
    <description>Fat-free mass (in kg, % of body mass [fat-free mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition, muscle mass</measure>
    <time_frame>One measurement assessed the day before the race</time_frame>
    <description>Muscle mass (in kg, % of body mass [muscle mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of Cold</measure>
    <time_frame>One measurement assessed immediately at the end of the race</time_frame>
    <description>Immediately at the end of the race participants' perception of cold was assessed using the Cold Discomfort Scale (CDS, with rating from 0-to-10 over 10, where 0 indicates no experience of cold and 10 indicates unbearable cold)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance</measure>
    <time_frame>Time at each lap of 2500m and at the end of the race</time_frame>
    <description>Time at each lap and swimming race timing was collected using the official swimming timing from the race organisers and French Federation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dropout rate</measure>
    <time_frame>During the swimming race and data were collected immediately after dropout for each swimmer who dropped out</time_frame>
    <description>Swimmers who dropout were identified and cause for dropout was collected</description>
  </secondary_outcome>
  <enrollment type="Actual">24</enrollment>
  <condition>Hypothermia Due to Cold Environment</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Swimming participants in the 25-km</intervention_name>
    <description>The 25-km race was the French national Open Championship event and participants were the swimmers registered for the race who volunteered to participate in this study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All the competitors of the 25-km French Open Water Championship who volunteered for this&#xD;
        study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  competitors of the 25-km French Open Water Championship&#xD;
&#xD;
          -  participants who volunteered for this study&#xD;
&#xD;
          -  written consent was obtained from all participants, as well as their legal&#xD;
             representatives when applicable (i.e. parents for under age participants).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  swallowing disorders&#xD;
&#xD;
          -  transit disorders&#xD;
&#xD;
          -  MRI scheduled within 48 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Joffrey Drigny, MD MSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Caen Normandie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Caen Normandie</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Caen</investigator_affiliation>
    <investigator_full_name>Joffrey DRIGNY</investigator_full_name>
    <investigator_title>Principal Investigator, Chief Resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</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/NCT04460339
org study id: THERMO25
nct id: NCT04460339
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Open water swimming is a swimming discipline which takes place in outdoor water such as open
      oceans, lakes, and rivers. Elite swimmers are exposed to hypothermia when swimming in cold
      water, especially in long duration races, such as the 25-km race. The objective of this study
      is to evaluate the change in body core temperature in swimmers with continuous temperature
      monitoring during a 25-km race. The secondary objective is to identify the predictors of
      hypothermia and hypothermia-related drop-out.
observational model: Cohort
time perspective: Prospective
measure: Change in Body Core Temperature
time frame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer
description: Measurement of Body Core Temperature using an ingestible electronic sensor (e-Celsius®, BodyCap , Caen, France) which provide a continuous validated measurement
measure: Change in Water Temperature
time frame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer
description: Measurement of the Water Temperature using an electronic sensor (iButton® Maxim Integrated) which provide a continuous validated measurement
measure: Body composition, body mass
time frame: One measurement assessed the day before the race
description: Body mass (in kg) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).
measure: Body composition, fat mass
time frame: One measurement assessed the day before the race
description: Fat mass (in kg, % of body mass [fat mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).
measure: Body composition, fat-free mass
time frame: One measurement assessed the day before the race
description: Fat-free mass (in kg, % of body mass [fat-free mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).
measure: Body composition, muscle mass
time frame: One measurement assessed the day before the race
description: Muscle mass (in kg, % of body mass [muscle mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).
measure: Perception of Cold
time frame: One measurement assessed immediately at the end of the race
description: Immediately at the end of the race participants' perception of cold was assessed using the Cold Discomfort Scale (CDS, with rating from 0-to-10 over 10, where 0 indicates no experience of cold and 10 indicates unbearable cold)
measure: Performance
time frame: Time at each lap of 2500m and at the end of the race
description: Time at each lap and swimming race timing was collected using the official swimming timing from the race organisers and French Federation
measure: Dropout rate
time frame: During the swimming race and data were collected immediately after dropout for each swimmer who dropped out
description: Swimmers who dropout were identified and cause for dropout was collected
intervention type: Other
intervention name: Swimming participants in the 25-km
description: The 25-km race was the French national Open Championship event and participants were the swimmers registered for the race who volunteered to participate in this study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 45 Years
last name: Joffrey Drigny, MD MSC
role: Principal Investigator
affiliation: CHU Caen Normandie
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Caen
investigator full name: Joffrey DRIGNY
investigator title: Principal Investigator, Chief Resident
mesh term: Hypothermia