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/NCT05967767</url>
    </required_header>
    <id_info>
      <org_study_id>Interventional</org_study_id>
      <nct_id>NCT05967767</nct_id>
    </id_info>
    <brief_title>Repeated Sprint Training in Normobaric Hypoxia</brief_title>
    <official_title>Three Sessions of Repeated Sprint Training in Normobaric Hypoxia With 48-Hour Interval Improves Repeated Sprint Performance Indices</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara University</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 current study was to examine the effects of 3-session repeated sprint training&#xD;
        performed in a normobaric hypoxic condition with 48-hour rest intervals on sprint performance&#xD;
        indices, arterial oxygen saturation (SpO2) and rating of perceived exertion (RPE) scores.&#xD;
        Twenty-four moderately-trained males participated in this study voluntarily basis. This study&#xD;
        was conducted on single-blind placebo-controlled design. Participants were divided into three&#xD;
        groups as follows; normobaric hypoxia (3420 m; HYP), normobaric normoxia (162 m; PLA) and&#xD;
        control group (CON). HYP and PLA groups subjected to 3 repeated sprint training session (4&#xD;
        set x 5 x 5 s sprints with 30 s recovery and 5 min rest between the sets) in normobaric&#xD;
        hypoxia or normoxia condition. Pre- and pos-test were conducted 72 hours before and after the&#xD;
        training intervention period. All the training and testing sessions performed in cycle&#xD;
        ergometer. There were no detected significant time and condition interaction in the&#xD;
        variables; relative peak power output (PPO), mean power output (MPO), percentage of sprint&#xD;
        decrement score (Sdec%) and RPE observed in the scope of pre- and post-test.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This single-blind placebo-controlled designed study was approved by Ankara University Human&#xD;
        Research Ethics Committee (2020/277) and conducted in accordance with the Declaration of&#xD;
        Helsinki. The participants in normobaric hypoxia (HYP) and placebo (PLA) groups visited the&#xD;
        laboratory six times and the control (CON) group visited three times. At the first visit of&#xD;
        participants, the aim and the possible outcomes of the research was explained, the&#xD;
        familiarization process for cycle ergometer and test/training protocol was performed, and the&#xD;
        informed consent forms were obtained. The participants were divided randomly into three&#xD;
        groups after the anthropometric measurements and baseline tests were completed so as part of&#xD;
        the second visit. The groups were divided as follows; HYP group (n=9) which were exposed to&#xD;
        normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %), PLA (n=7) that were exposed to&#xD;
        normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator&#xD;
        mask, and the control group (CON; n=8) which was subjected to only pre and post-test. The&#xD;
        determined hypoxic dose for HYP group was directly implemented (setting 9 was equal to 3420 m&#xD;
        on used hypoxia generator), and no correction was made for the actual altitude (900 m,&#xD;
        Golbasi, Ankara, Türkiye). The normobaric hypoxia and placebo condition was provided by&#xD;
        Everest Summit II-Altitude Generator (Hypoxico Hypoxicator, New York, USA). At the 3rd-5th&#xD;
        visits, HYP and PLA groups performed 3 repeated sprint training sessions under normobaric&#xD;
        hypoxia or normoxia exposure with 48-hour intervals. And the participants visited the&#xD;
        laboratory last time for post-test measurements. Each participant visited the laboratory for&#xD;
        training sessions and test trials at the same time in the day. In the scope of pre and&#xD;
        post-test repeated sprint indices, SpO2 and RPE data were collected. Pre-test and post-test&#xD;
        were conducted 72 hours before and 72 hours after the training intervention period in&#xD;
        normobaric normoxia condition. Including the testing days, the intervention period lasted 11&#xD;
        days in November 2022. All the experimental processes were conducted in Ankara University&#xD;
        Performance Laboratory.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Actual">December 19, 2022</completion_date>
    <primary_completion_date type="Actual">November 25, 2022</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>
      <intervention_model_description>single-blind placebo-controlled design</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>In this study, blinding was provided in practice by using the simulation device for the normoxia condition.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Relative Peak Power Output</measure>
      <time_frame>11 days</time_frame>
      <description>Relative peak power output (as newton meter) produced during the repeated cycling sprint tests by the participant in the scope of pre and post tests were recorded and assessed via Lode Cycling Ergometer Software. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Relative Mean Power Output</measure>
      <time_frame>11 days</time_frame>
      <description>Relative mean power output (as newton meter) produced during the repeated cycling sprint tests by the participant in the scope of pre and post tests were recorded and assessed via Lode Cycling Ergometer Software. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of Sprint Decrement Score</measure>
      <time_frame>11 days</time_frame>
      <description>Percentage of sprint decrement score calculated via relative peak power output produced during the repeated cycling sprint tests by the each participant in the scope of pre and post tests. The used sprint decrement score formula was as the follows; &quot;Sdec% = [1 - (total power/ideal power)] × 100&quot;. Total power refers to accumulated PPO over the number of sprints and ideal power is defines the achieved highest PPO over the repetitions. An increase in the obtained score means that the sprint performance decreases.The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Arterial Oxygen Saturation</measure>
      <time_frame>11 days</time_frame>
      <description>Arterial oxygen saturation was measured and recorded via fingertip oximeter during the repeated cycling sprint tests for the end of the each sprint. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Perceived Exertion</measure>
      <time_frame>11 days</time_frame>
      <description>Rate of Perceived exertion evaluated via 6-20 Borg scale and recorded during the repeated cycling sprint tests for the end of the each sprint. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.&#xD;
  Scoring Level of Exertion 6 No Exertion 7 Extremely Light 8 9 Very Light 10 11 Light 12 13 Somewhat Hard 14 15 Hard (Heavy) 16 17 Very Hard 18 19 Extremely Hard 20 Maximal Exertion</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Hypoxia</condition>
    <arm_group>
      <arm_group_label>3 Session Repeated Sprint Training in Normobaric Hypoxia</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Hypoxia group was exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3 Session Repeated Sprint Training in Normobaric Normoxia</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Placebo group was exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group was subjected to only pre and post-test.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Normobaric Hypoxia Exposure</intervention_name>
      <description>Hypoxia group were exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %).</description>
      <arm_group_label>3 Session Repeated Sprint Training in Normobaric Hypoxia</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Normobaric Normoxia Exposure</intervention_name>
      <description>Placebo group were exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask.</description>
      <arm_group_label>3 Session Repeated Sprint Training in Normobaric Normoxia</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  non-smokers,&#xD;
  &#xD;
            -  male gender,&#xD;
  &#xD;
            -  those who do not have any chronic disease,&#xD;
  &#xD;
            -  do not use any medication,&#xD;
  &#xD;
            -  do not any training or accommodate above 1500 m altitude within the past 3 months,&#xD;
  &#xD;
            -  do not have any musculoskeletal injuries within the past 6 months and,&#xD;
  &#xD;
            -  train at least 3 days in a week.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a chronic or acute condition/disease during the intervention period&#xD;
  &#xD;
            -  Occurrence of acute respiratory illness or musculoskeletal injury during the&#xD;
               intervention period&#xD;
  &#xD;
            -  Leaving the study voluntarily/on his own account&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>22 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ankara University</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Trabzon University</investigator_affiliation>
      <investigator_full_name>Abdulkadir Birol</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>normobaric hypoxia</keyword>
    <keyword>repeated sprint training</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypoxia</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/NCT05967767
  org study id: Interventional
  nct id: NCT05967767
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the current study was to examine the effects of 3-session repeated sprint training
        performed in a normobaric hypoxic condition with 48-hour rest intervals on sprint performance
        indices, arterial oxygen saturation (SpO2) and rating of perceived exertion (RPE) scores.
        Twenty-four moderately-trained males participated in this study voluntarily basis. This study
        was conducted on single-blind placebo-controlled design. Participants were divided into three
        groups as follows; normobaric hypoxia (3420 m; HYP), normobaric normoxia (162 m; PLA) and
        control group (CON). HYP and PLA groups subjected to 3 repeated sprint training session (4
        set x 5 x 5 s sprints with 30 s recovery and 5 min rest between the sets) in normobaric
        hypoxia or normoxia condition. Pre- and pos-test were conducted 72 hours before and after the
        training intervention period. All the training and testing sessions performed in cycle
        ergometer. There were no detected significant time and condition interaction in the
        variables; relative peak power output (PPO), mean power output (MPO), percentage of sprint
        decrement score (Sdec%) and RPE observed in the scope of pre- and post-test.
  This single-blind placebo-controlled designed study was approved by Ankara University Human
        Research Ethics Committee (2020/277) and conducted in accordance with the Declaration of
        Helsinki. The participants in normobaric hypoxia (HYP) and placebo (PLA) groups visited the
        laboratory six times and the control (CON) group visited three times. At the first visit of
        participants, the aim and the possible outcomes of the research was explained, the
        familiarization process for cycle ergometer and test/training protocol was performed, and the
        informed consent forms were obtained. The participants were divided randomly into three
        groups after the anthropometric measurements and baseline tests were completed so as part of
        the second visit. The groups were divided as follows; HYP group (n=9) which were exposed to
        normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %), PLA (n=7) that were exposed to
        normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator
        mask, and the control group (CON; n=8) which was subjected to only pre and post-test. The
        determined hypoxic dose for HYP group was directly implemented (setting 9 was equal to 3420 m
        on used hypoxia generator), and no correction was made for the actual altitude (900 m,
        Golbasi, Ankara, Türkiye). The normobaric hypoxia and placebo condition was provided by
        Everest Summit II-Altitude Generator (Hypoxico Hypoxicator, New York, USA). At the 3rd-5th
        visits, HYP and PLA groups performed 3 repeated sprint training sessions under normobaric
        hypoxia or normoxia exposure with 48-hour intervals. And the participants visited the
        laboratory last time for post-test measurements. Each participant visited the laboratory for
        training sessions and test trials at the same time in the day. In the scope of pre and
        post-test repeated sprint indices, SpO2 and RPE data were collected. Pre-test and post-test
        were conducted 72 hours before and 72 hours after the training intervention period in
        normobaric normoxia condition. Including the testing days, the intervention period lasted 11
        days in November 2022. All the experimental processes were conducted in Ankara University
        Performance Laboratory.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: single-blind placebo-controlled design
  primary purpose: Other
  masking: Single (Participant)
  masking description: In this study, blinding was provided in practice by using the simulation device for the normoxia condition.
  measure: Relative Peak Power Output
  time frame: 11 days
  description: Relative peak power output (as newton meter) produced during the repeated cycling sprint tests by the participant in the scope of pre and post tests were recorded and assessed via Lode Cycling Ergometer Software. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
  measure: Relative Mean Power Output
  time frame: 11 days
  description: Relative mean power output (as newton meter) produced during the repeated cycling sprint tests by the participant in the scope of pre and post tests were recorded and assessed via Lode Cycling Ergometer Software. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
  measure: Percentage of Sprint Decrement Score
  time frame: 11 days
  description: Percentage of sprint decrement score calculated via relative peak power output produced during the repeated cycling sprint tests by the each participant in the scope of pre and post tests. The used sprint decrement score formula was as the follows; "Sdec% = [1 - (total power/ideal power)] × 100". Total power refers to accumulated PPO over the number of sprints and ideal power is defines the achieved highest PPO over the repetitions. An increase in the obtained score means that the sprint performance decreases.The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
  measure: Arterial Oxygen Saturation
  time frame: 11 days
  description: Arterial oxygen saturation was measured and recorded via fingertip oximeter during the repeated cycling sprint tests for the end of the each sprint. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
  measure: Rate of Perceived Exertion
  time frame: 11 days
  description: Rate of Perceived exertion evaluated via 6-20 Borg scale and recorded during the repeated cycling sprint tests for the end of the each sprint. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
  Scoring Level of Exertion 6 No Exertion 7 Extremely Light 8 9 Very Light 10 11 Light 12 13 Somewhat Hard 14 15 Hard (Heavy) 16 17 Very Hard 18 19 Extremely Hard 20 Maximal Exertion
  arm group label: 3 Session Repeated Sprint Training in Normobaric Hypoxia
  arm group type: Experimental
  description: Hypoxia group was exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %).
  arm group label: 3 Session Repeated Sprint Training in Normobaric Normoxia
  arm group type: Sham Comparator
  description: Placebo group was exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask.
  arm group label: Control group
  arm group type: No Intervention
  description: The control group was subjected to only pre and post-test.
  intervention type: Device
  intervention name: Normobaric Hypoxia Exposure
  description: Hypoxia group were exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %).
  arm group label: 3 Session Repeated Sprint Training in Normobaric Hypoxia
  intervention type: Device
  intervention name: Normobaric Normoxia Exposure
  description: Placebo group were exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask.
  arm group label: 3 Session Repeated Sprint Training in Normobaric Normoxia
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 22 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Trabzon University
  investigator full name: Abdulkadir Birol
  investigator title: Assistant Professor
  mesh term: Hypoxia