<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/NCT03306511</url>
  </required_header>
  <id_info>
    <org_study_id>SPRINT2017</org_study_id>
    <nct_id>NCT03306511</nct_id>
  </id_info>
  <brief_title>Sprint Performance in Football Players With a Previous Hamstring Injury</brief_title>
  <official_title>Sprint Performance in Football Players With a Previous Hamstring Injury Compared to Healthy Controls: An Exploratory Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hvidovre University Hospital</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>
      Few studies indicate that sprint performance may be impaired in football players with a&#xD;
      previous hamstring strain injury. This exploratory cross-sectional study aim to compare&#xD;
      sprint performance between football players with and without a previous hamstring strain&#xD;
      injury. The findings may elucidate potential indications of insufficient rehabilitation&#xD;
      following a hamstring strain injury.&#xD;
&#xD;
      Sprint performance data will be collected using the MySprint Iphone Application.&#xD;
&#xD;
      Due to pragmatic reasons and the exploratory nature of this study the aim is to include&#xD;
      players on a team level.&#xD;
&#xD;
      Based on the prevalence of hamstring strain injuries the expected number of cases to be&#xD;
      included are 10-20 football players with a previous hamstring strain injury, and a&#xD;
      corresponding 80-90 number of healthy controls.&#xD;
&#xD;
      No outcomes will be weighted (flat outcome structure).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Theoretical maximal force</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Theoretical maximal velocity</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Theoritical maximal power output</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Slope of the linear decrease on ratio of force as sprint velocity increases</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">44</enrollment>
  <condition>Sprint Performance</condition>
  <condition>Hamstring Injury</condition>
  <arm_group>
    <arm_group_label>Case</arm_group_label>
    <description>Football players with a previous self-reported hamstring strain injury in the preceding 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Football players without a previous self-reported hamstring strain injury in the preceding 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Repeated-sprint test</intervention_name>
    <description>6x30-meter sprint interspersed with 90-s rest</description>
    <arm_group_label>Case</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Danish competitive football players&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria Controls:&#xD;
&#xD;
          -  Able to participate fully in regular football training and matches&#xD;
&#xD;
        Exclusion Criteria Controls:&#xD;
&#xD;
          -  Self-reported hamstring strain injury resulting in loss of regular football training&#xD;
             sessions or football matches in the preceding 12 months.&#xD;
&#xD;
          -  Longstanding injury (&gt;6 weeks) in the lower extremities or trunk in the preceding 12&#xD;
             months.&#xD;
&#xD;
          -  Any pain in the lower extremity, pelvis, or spine during testing&#xD;
&#xD;
        Inclusion Criteria Cases:&#xD;
&#xD;
          -  Able to participate fully in regular football training and matches&#xD;
&#xD;
          -  Self-reported hamstring strain injury resulting in loss of regular football training&#xD;
             sessions or football matches in the preceding 12 months.&#xD;
&#xD;
        Exclusion Criteria Cases:&#xD;
&#xD;
          -  Longstanding injury (&gt;6 weeks) in the lower extremities (except hamstring strain&#xD;
             injury) or trunk in the preceding 12 months.&#xD;
&#xD;
          -  Any pain in the lower extremity, pelvis, or spine during testing&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lasse Ishøi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hvidovre University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Testing will be conducted in the facilities of the included football clubs in Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <state>Danmark</state>
        <zip>1904</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>June 12, 2018</last_update_submitted>
  <last_update_submitted_qc>June 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Lasse Ishøi</investigator_full_name>
    <investigator_title>MSc</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03306511
org study id: SPRINT2017
nct id: NCT03306511
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Few studies indicate that sprint performance may be impaired in football players with a
      previous hamstring strain injury. This exploratory cross-sectional study aim to compare
      sprint performance between football players with and without a previous hamstring strain
      injury. The findings may elucidate potential indications of insufficient rehabilitation
      following a hamstring strain injury.

      Sprint performance data will be collected using the MySprint Iphone Application.

      Due to pragmatic reasons and the exploratory nature of this study the aim is to include
      players on a team level.

      Based on the prevalence of hamstring strain injuries the expected number of cases to be
      included are 10-20 football players with a previous hamstring strain injury, and a
      corresponding 80-90 number of healthy controls.

      No outcomes will be weighted (flat outcome structure).
observational model: Case-Control
time perspective: Cross-Sectional
measure: Theoretical maximal force
time frame: Baseline
description: Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.
measure: Theoretical maximal velocity
time frame: Baseline
description: Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.
measure: Theoritical maximal power output
time frame: Baseline
description: Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.
measure: Slope of the linear decrease on ratio of force as sprint velocity increases
time frame: Baseline
description: Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.
arm group label: Case
description: Football players with a previous self-reported hamstring strain injury in the preceding 12 months
arm group label: Control
description: Football players without a previous self-reported hamstring strain injury in the preceding 12 months
intervention type: Other
intervention name: Repeated-sprint test
description: 6x30-meter sprint interspersed with 90-s rest
arm group label: Case
arm group label: Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Lasse Ishøi
role: Principal Investigator
affiliation: Hvidovre University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Lasse Ishøi
investigator title: MSc
mesh term: Wounds and Injuries
sharing ipd: Undecided