<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/NCT02203539</url>
  </required_header>
  <id_info>
    <org_study_id>EKNZ 2014-056</org_study_id>
    <nct_id>NCT02203539</nct_id>
  </id_info>
  <brief_title>The Influence of Light Exposure on Exercise Performance Dependent on Chronotype.</brief_title>
  <acronym>EX-Light</acronym>
  <official_title>The Influence of Different Light Exposures on Endurance Performance, Handgrip Strength and Reaction Time in Consideration of the Chronotype.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Basel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Basel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if an exposure to light in the evening has a&#xD;
      positive influence on physical performance regarding endurance, strength and reaction time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Work performed in kilo Joule (kJ) during the time trial ergometer test adjusted for the VO2peak.</measure>
    <time_frame>The outcome measure will be assesed at the end of the 12minute time trial ergometer test.</time_frame>
    <description>Participants will perform one baseline test (ergometer ramp test) and seven days later a twelve minute lasting ergometer time trial test which starts 10 minutes after an exposure to light for 60minutes. The work performed in kilo Joule during the time trial ergometer test will be assesed at the end of the time trial and will be the main outcome measure and adjusted for the VO2peak meausred during the baseline test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reaction time in milliseconds (ms)</measure>
    <time_frame>Reaction time task will be performed at baseline (20 to 15 minutes before the light exposure) and 0 to minutes after the light exposure which will be the secondary outcome measure.</time_frame>
    <description>Participants will perform one baseline reaction time task 20 to 15 minutes before the light exposure. 0 to 5 minutes after the 60 minutes lasting light exposure they will perform the reaction task again. The time in milliseconds from the reaction task after the light exposure will be the secondary outcome measure and adjusted for the baseline test before light exposure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum handgrip strength in kilo gramm (kg)</measure>
    <time_frame>Maximum handgrip strength will be tested at baseline (15 to 10 minutes before the light exposure) and 5 to 10 minutes after the 60 minutes lasting light exposure.</time_frame>
    <description>Participants will perform one baseline maximum hand grip strength test 15 to 10 minutes before the 60 minutes lasting light exposusre and perform a second test, which will be the outcome measure 5 to 10 minutes after the light exposure. The strength in kg will be adjusted for the strength in kg measured at baseline.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Endurance Performance</condition>
  <condition>Reaction Time</condition>
  <condition>Muscle Strength</condition>
  <arm_group>
    <arm_group_label>bright light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: exposure to bright light</description>
  </arm_group>
  <arm_group>
    <arm_group_label>blue-enriched light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: exposure to blue-enriched light</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: exposure to normal light</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exposure to normal light</intervention_name>
    <description>exposure for 60 minutes in duration</description>
    <arm_group_label>normal light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exposure to bright light</intervention_name>
    <description>exposure to bright light for 60 minutes of duration</description>
    <arm_group_label>bright light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exposure to blue-enriched light</intervention_name>
    <description>exposure to blue-enriched light for 60 minutes of duration</description>
    <arm_group_label>blue-enriched light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  BMI 18 to 30 kg/m2&#xD;
&#xD;
          -  endurance performance &gt;= 55 ml/min/kg peak oxygen uptake&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  cardiovascular disease&#xD;
&#xD;
          -  renal dysfunction&#xD;
&#xD;
          -  shiftworking&#xD;
&#xD;
          -  travels over time zones in the last 4 weeks&#xD;
&#xD;
          -  high blood pressure (systolic blood pressure &gt;170mmHg, diastolic blood pressure&#xD;
             &gt;100mmHg)&#xD;
&#xD;
          -  depression&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arno Schmidt-Trucksäss, Prof Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Departement of Sports, Exercise and Health, University of Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department for Sport, Exercise and Health, Section Sports and Exercise Medicine, University of Basel</name>
      <address>
        <city>Basel</city>
        <zip>4052</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>April 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 1, 2015</last_update_submitted>
  <last_update_submitted_qc>July 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Basel</investigator_affiliation>
    <investigator_full_name>Arno Schmidt-Trucksäss</investigator_full_name>
    <investigator_title>Prof Arno Schmidt-Trucksäss, MD, MA</investigator_title>
  </responsible_party>
  <keyword>circadian rhythm</keyword>
  <keyword>light exposure</keyword>
  <keyword>exercise capacity</keyword>
  <keyword>endurance</keyword>
  <keyword>strength</keyword>
  <keyword>reaction</keyword>
  <!-- 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/NCT02203539
org study id: EKNZ 2014-056
nct id: NCT02203539
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine if an exposure to light in the evening has a
      positive influence on physical performance regarding endurance, strength and reaction time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Work performed in kilo Joule (kJ) during the time trial ergometer test adjusted for the VO2peak.
time frame: The outcome measure will be assesed at the end of the 12minute time trial ergometer test.
description: Participants will perform one baseline test (ergometer ramp test) and seven days later a twelve minute lasting ergometer time trial test which starts 10 minutes after an exposure to light for 60minutes. The work performed in kilo Joule during the time trial ergometer test will be assesed at the end of the time trial and will be the main outcome measure and adjusted for the VO2peak meausred during the baseline test.
measure: Reaction time in milliseconds (ms)
time frame: Reaction time task will be performed at baseline (20 to 15 minutes before the light exposure) and 0 to minutes after the light exposure which will be the secondary outcome measure.
description: Participants will perform one baseline reaction time task 20 to 15 minutes before the light exposure. 0 to 5 minutes after the 60 minutes lasting light exposure they will perform the reaction task again. The time in milliseconds from the reaction task after the light exposure will be the secondary outcome measure and adjusted for the baseline test before light exposure.
measure: Maximum handgrip strength in kilo gramm (kg)
time frame: Maximum handgrip strength will be tested at baseline (15 to 10 minutes before the light exposure) and 5 to 10 minutes after the 60 minutes lasting light exposure.
description: Participants will perform one baseline maximum hand grip strength test 15 to 10 minutes before the 60 minutes lasting light exposusre and perform a second test, which will be the outcome measure 5 to 10 minutes after the light exposure. The strength in kg will be adjusted for the strength in kg measured at baseline.
arm group label: bright light
arm group type: Experimental
description: Intervention: exposure to bright light
arm group label: blue-enriched light
arm group type: Experimental
description: Intervention: exposure to blue-enriched light
arm group label: normal light
arm group type: Experimental
description: Intervention: exposure to normal light
intervention type: Other
intervention name: exposure to normal light
description: exposure for 60 minutes in duration
arm group label: normal light
intervention type: Other
intervention name: exposure to bright light
description: exposure to bright light for 60 minutes of duration
arm group label: bright light
intervention type: Other
intervention name: exposure to blue-enriched light
description: exposure to blue-enriched light for 60 minutes of duration
arm group label: blue-enriched light
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Arno Schmidt-Trucksäss, Prof Dr
role: Principal Investigator
affiliation: Departement of Sports, Exercise and Health, University of Basel
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Basel
investigator full name: Arno Schmidt-Trucksäss
investigator title: Prof Arno Schmidt-Trucksäss, MD, MA