<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20180526039850N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-03</date_registration>
      <primary_sponsor>Research Deputy of Sports Sciences Research Institute, Sports Sciences Research Institute</primary_sponsor>
      <public_title>Investigating the Effect of the 11+ Program on Prevention of Injuries  in Football Players</public_title>
      <acronym></acronym>
      <scientific_title>The “11+ Kids” warm-up programme to prevent injuries in young high-level football players: a cluster randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>1250</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31846</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: all high-level football schools from five provinces of Iran were invited to participate in the study. Participating clubs were randomly allocated to an intervention group and a control group. All teams of the same club were allocated to the same group to minimize the risk of contamination. An automated randomization procedure was conducted by a researcher who had no direct contact with the clubs or team officials and who was not involved in the intervention. The number of participating teams per club and the age group served as strata for the randomization, Blinding description: by a researcher who had no direct contact with the clubs or team officials and who was not involved in the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Dislocation, sprain and strain of joints and ligaments of knee. Condition 2: Superficial injury of ankle and foot. Condition 3: Superficial injury of hip and thigh.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  used the new injury prevention programme (“11+ Kids”) as a warm-up during the season. Intervention 2: Control group:  used  routine warm-up programme during the season.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data relating to the control and intervention group in the pre and post test groups will be shared as unidentified.

When:
Six months after the publication of the articles

To whom:
All the researchers

Conditions:
data is allowed to use in case of citing the reference

Where to obtain:
hamed abbasi

How to obtain:
by  an email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1587958711</zip>
        <telephone>+98 21 8852 9121</telephone>
        <email>h.abbasi@ssrc.ac.ir</email>
        <affiliation>Sports Sciences Research Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1587958711</zip>
        <telephone>+98 21 8852 9121</telephone>
        <email>h.abbasi@ssrc.ac.ir</email>
        <affiliation>Sports Sciences Research Institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>teams are competing in the highest league of their province
players are between 7 and 14 years old at the start of the study
regular training must take place at least twice per week</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>14 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>If  the teams already used an exercise-based injury prevention measure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S80</hc_code>
      <hc_code>S90</hc_code>
      <hc_code>S70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Superficial injury of knee and lower leg</hc_keyword>
      <hc_keyword>Superficial injury of ankle, foot and toes</hc_keyword>
      <hc_keyword>Superficial injury of hip and thigh</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  used the new injury prevention programme (“11+ Kids”) as a warm-up during the season</i_keyword>
      <i_keyword>Control group:  used  routine warm-up programme during the season</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Football related lower extremity injuries. Timepoint: Through one football season. Method of measurement: Reporting.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knee injuries Ankle injuries,. Timepoint: 36 weeks. Method of measurement: Sport Injuries Registration Form.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Research Deputy of Sports Sciences Research Institute, Sports Sciences Research Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-23</approval_date>
        <contact_name>Ethics committee of Sports Sciences Research Institute</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
