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/NCT05994469</url>
    </required_header>
    <id_info>
      <org_study_id>UO2023/1</org_study_id>
      <nct_id>NCT05994469</nct_id>
    </id_info>
    <brief_title>Prevention of Groin Injuries in Rink Hockey</brief_title>
    <official_title>Prevention of Groin Injuries in Rink Hockey: A One Season Natural Experiment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oviedo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Oviedo</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>
        Rink hockey teams from senior category (adults) will be recruited to implement a groin injury&#xD;
        prevention program consisting on the Copenhagen Adduction Exercise (CAE) throughout the&#xD;
        regular season, 0 times, once or twice per week (september 2023-march 2024)&#xD;
  &#xD;
        Weekly team exposure to training sessions and games will be collected as well as cases of&#xD;
        groin problems in the entire population&#xD;
  &#xD;
        When the season ends, the number of groin problems will be compared between teams that used&#xD;
        the prevention program once a week against twice a week or no sessions a week.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rink hockey teams will be offered a prevention program consisting on the CAE to be performed&#xD;
        during the season.&#xD;
  &#xD;
        Teams will decide to implement the protocol once, twice or 0 times per week, depending on&#xD;
        their schedule. No formal control group will be set, comparison of injuries will be performed&#xD;
        between teams that used +80% of the total possible sessions and -80% (28 weeks equals a&#xD;
        potential 56 CAE sessions throughout the season).&#xD;
  &#xD;
        On a weekly basis, coaches will be contacted to report number of training sessions, games,&#xD;
        and training sessions where they implemented CAE.&#xD;
  &#xD;
        Bi-weekly, players will report any episode of groin problems (both leading to time-loss and&#xD;
        those only affecting performance while not limiting participation).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">May 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Natural experiment</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Bi-Weekly prevalence of groin problems</measure>
      <time_frame>Every 14 days throughout the entire study (which lasts 7 months)</time_frame>
      <description>number of groin pain complaints in a 14-day frame, groin pain is described as pain in the groin region which emerges from performing exercise and may be indicative of an injury to the adductor muscles, abdominals, hip flexors, or pubic joint</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adherence to the intervention</measure>
      <time_frame>Every 7 days throughout the entire study (which lasts 7 months)</time_frame>
      <description>Since the intervention is implemented on a weekly basis, the number of sessions performed by the participating teams will be collected to calculate the total compliance with the intervention. From a total of 56 possible sessions a team may complete 47 which equals 83% compliance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hockey exposure</measure>
      <time_frame>Every 7 days throughout the entire study (which lasts 7 months)</time_frame>
      <description>number of training sessions and games per week this metric is collected to calculate exposure hours, so that groin problems can be compared as nº of injuries / 1000 hours of exposure, as the International Olympic Committee recommends</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Groin Injury</condition>
    <condition>Groin Strain</condition>
    <condition>Adductor Strain</condition>
    <arm_group>
      <arm_group_label>Copenhagen Adduction Exercise Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>there is no control group, all teams can implement the intervention protocol that better fits their normal schedule, the intervention can consist of 1 or 2 Copenhagen Adduction Exercise sessions per week</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Copenhagen Adduction Exercise</intervention_name>
      <description>The CAE is performed by side-lying on the floor with the dominant lower limb supported in the air by a teammate, the hip is adducted until the body forms a straight line from the ankles to the shoulders (concentric phase), then the player is instructed to lower the body slowly (eccentric phase) until reaching the floor to start the next repetition.</description>
      <arm_group_label>Copenhagen Adduction Exercise Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  #1 Be part of a rink hockey team competing in senior league (either local (third&#xD;
               division/lower) or national (first and second division))&#xD;
  &#xD;
                 -  2 Accept participating in the study (signing the informed consent)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  #1 not playing rink hockey in the previous season&#xD;
  &#xD;
                 -  2 serious illness, injury or surgery in the previous 6 months that prevented rink&#xD;
                    hockey participation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hugo Olmedillas</name>
        <address>
          <city>Oviedo</city>
          <state>Asturias</state>
          <zip>33006</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hugo Olmedillas, PhD</last_name>
        <phone>985105586</phone>
        <phone_ext>+34</phone_ext>
        <email>olmedillashugo@uniovi.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/29891614/</url>
      <description>Previous research similar to this project</description>
    </link>
    <link>
      <url>https://doi.org/10.1007/s00167-021-06644-2</url>
      <description>Previous research similar to this project</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Oviedo</investigator_affiliation>
      <investigator_full_name>Hugo Olmedillas Fernandez</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>rink hockey</keyword>
    <keyword>groin pain</keyword>
    <keyword>injury prevention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Sprains and Strains</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05994469
  org study id: UO2023/1
  nct id: NCT05994469
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rink hockey teams from senior category (adults) will be recruited to implement a groin injury
        prevention program consisting on the Copenhagen Adduction Exercise (CAE) throughout the
        regular season, 0 times, once or twice per week (september 2023-march 2024)
  
        Weekly team exposure to training sessions and games will be collected as well as cases of
        groin problems in the entire population
  
        When the season ends, the number of groin problems will be compared between teams that used
        the prevention program once a week against twice a week or no sessions a week.
  Rink hockey teams will be offered a prevention program consisting on the CAE to be performed
        during the season.
  
        Teams will decide to implement the protocol once, twice or 0 times per week, depending on
        their schedule. No formal control group will be set, comparison of injuries will be performed
        between teams that used +80% of the total possible sessions and -80% (28 weeks equals a
        potential 56 CAE sessions throughout the season).
  
        On a weekly basis, coaches will be contacted to report number of training sessions, games,
        and training sessions where they implemented CAE.
  
        Bi-weekly, players will report any episode of groin problems (both leading to time-loss and
        those only affecting performance while not limiting participation).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Natural experiment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Bi-Weekly prevalence of groin problems
  time frame: Every 14 days throughout the entire study (which lasts 7 months)
  description: number of groin pain complaints in a 14-day frame, groin pain is described as pain in the groin region which emerges from performing exercise and may be indicative of an injury to the adductor muscles, abdominals, hip flexors, or pubic joint
  measure: Adherence to the intervention
  time frame: Every 7 days throughout the entire study (which lasts 7 months)
  description: Since the intervention is implemented on a weekly basis, the number of sessions performed by the participating teams will be collected to calculate the total compliance with the intervention. From a total of 56 possible sessions a team may complete 47 which equals 83% compliance
  measure: hockey exposure
  time frame: Every 7 days throughout the entire study (which lasts 7 months)
  description: number of training sessions and games per week this metric is collected to calculate exposure hours, so that groin problems can be compared as nº of injuries / 1000 hours of exposure, as the International Olympic Committee recommends
  arm group label: Copenhagen Adduction Exercise Group
  arm group type: Experimental
  description: there is no control group, all teams can implement the intervention protocol that better fits their normal schedule, the intervention can consist of 1 or 2 Copenhagen Adduction Exercise sessions per week
  intervention type: Behavioral
  intervention name: Copenhagen Adduction Exercise
  description: The CAE is performed by side-lying on the floor with the dominant lower limb supported in the air by a teammate, the hip is adducted until the body forms a straight line from the ankles to the shoulders (concentric phase), then the player is instructed to lower the body slowly (eccentric phase) until reaching the floor to start the next repetition.
  arm group label: Copenhagen Adduction Exercise Group
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  url: https://pubmed.ncbi.nlm.nih.gov/29891614/
  description: Previous research similar to this project
  url: https://doi.org/10.1007/s00167-021-06644-2
  description: Previous research similar to this project
  responsible party type: Principal Investigator
  investigator affiliation: University of Oviedo
  investigator full name: Hugo Olmedillas Fernandez
  investigator title: Principal Investigator
  mesh term: Wounds and Injuries
  mesh term: Sprains and Strains
  sharing ipd: No