<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/NCT04448925</url>
  </required_header>
  <id_info>
    <org_study_id>UTexasAustinHPL</org_study_id>
    <nct_id>NCT04448925</nct_id>
  </id_info>
  <brief_title>Physiological Responses to Maximal 4-s Sprint Interval Cycling</brief_title>
  <official_title>Physiological Responses to Maximal 4-s Sprint Interval Cycling Using Inertial Loading: the Influence of Inter-sprint Recovery Duration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas at Austin</source>
  <oversight_info>
    <has_dmc>Yes</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 optimal recovery duration depends on the intensity of exercise and in the present study&#xD;
      the intensity was maximal power for 4-s while cycling an 'Inertial Load' ergometer (ILE).&#xD;
      Recovery duration of 15, 30 and 45-s were given between 30 successive sprints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All subjects completed an informed consent for this study that was approved by the&#xD;
      Institutional Review Board of the University of Texas at Austin.&#xD;
&#xD;
      Study Overview. A randomized, cross-over experimental design was conducted. Each participant&#xD;
      visited the laboratory on four occasions which were separated by two to five days.&#xD;
      Measurement of body mass, familiarization with experimental procedures and cycling peak&#xD;
      oxygen consumption test (VO2peak) were performed on the first visit. Participants took part&#xD;
      in inertial-load exercise (ILE) on the remaining test days. On each separate session, a&#xD;
      different inter-sprint recovery duration was employed (i.e. 15, 30 or 45-s). Cycling power&#xD;
      output, pulmonary gas exchange, vastus lateralis de-oxygenation status, heart rate and blood&#xD;
      lactate were measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">July 20, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Repeated measures, cross-over</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>maximal leg power</measure>
    <time_frame>10 min</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Exercise, Cardiovascular Function, Fatigue, Muscular Power</condition>
  <arm_group>
    <arm_group_label>Recovery duration 15 seconds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resting for 15 sec</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recovery duration 30 seconds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resting for 30 sec</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recovery duration 45 seconds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resting for 45 sec</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>inertial-load exercise (ILE)</intervention_name>
    <description>Length of time between exercise bouts</description>
    <arm_group_label>Recovery duration 15 seconds</arm_group_label>
    <arm_group_label>Recovery duration 30 seconds</arm_group_label>
    <arm_group_label>Recovery duration 45 seconds</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy participants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unhealthy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Texas at Austin Human Performance Laboratory</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</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>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>all data will be grouped and averaged</ipd_description>
  </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/NCT04448925
org study id: UTexasAustinHPL
nct id: NCT04448925
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The optimal recovery duration depends on the intensity of exercise and in the present study
      the intensity was maximal power for 4-s while cycling an 'Inertial Load' ergometer (ILE).
      Recovery duration of 15, 30 and 45-s were given between 30 successive sprints.
All subjects completed an informed consent for this study that was approved by the
      Institutional Review Board of the University of Texas at Austin.

      Study Overview. A randomized, cross-over experimental design was conducted. Each participant
      visited the laboratory on four occasions which were separated by two to five days.
      Measurement of body mass, familiarization with experimental procedures and cycling peak
      oxygen consumption test (VO2peak) were performed on the first visit. Participants took part
      in inertial-load exercise (ILE) on the remaining test days. On each separate session, a
      different inter-sprint recovery duration was employed (i.e. 15, 30 or 45-s). Cycling power
      output, pulmonary gas exchange, vastus lateralis de-oxygenation status, heart rate and blood
      lactate were measured.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Repeated measures, cross-over
primary purpose: Basic Science
masking: None (Open Label)
measure: maximal leg power
time frame: 10 min
arm group label: Recovery duration 15 seconds
arm group type: Experimental
description: Resting for 15 sec
arm group label: Recovery duration 30 seconds
arm group type: Experimental
description: Resting for 30 sec
arm group label: Recovery duration 45 seconds
arm group type: Experimental
description: Resting for 45 sec
intervention type: Other
intervention name: inertial-load exercise (ILE)
description: Length of time between exercise bouts
arm group label: Recovery duration 15 seconds
arm group label: Recovery duration 30 seconds
arm group label: Recovery duration 45 seconds
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fatigue
sharing ipd: No
ipd description: all data will be grouped and averaged