<?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>IRCT20250823066957N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-04</date_registration>
      <primary_sponsor>The University of shahid Beheshti of Tehran</primary_sponsor>
      <public_title>Investigating the effect of ACL injury prevention exercises on functional indices</public_title>
      <acronym>PEP</acronym>
      <scientific_title>The effect of an eight-week ACL injury prevention training protocol on performance indicators of professional male volleyball players.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85706</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The allocation of participants to the intervention and control groups will be carried out randomly. After selecting eligible players based on the inclusion and exclusion criteria, a list of names will be prepared and each participant will be assigned a number. Using a simple randomization method (lottery drawing), the numbers will then be distributed into two groups of 15 players each. No non-random or subjective criteria will be applied in this process in order to minimize the risk of selection bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The study subjects will include professional male volleyball players (aged 16–20 years) who meet the eligibility criteria and will participate in the injury prevention training program (PEP) during the study..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will perform the anterior cruciate ligament (ACL) injury prevention program (PEP) three times per week for eight weeks. The program will last approximately 15–20 minutes and will include five components: warm-up, strength, plyometric, agility, and stretching exercises, implemented at the beginning of the main training session as a substitute for the regular warm-up. The aim of this intervention will be to improve neuromuscular control, increase explosive power, enhance dynamic balance, and ultimately reduce the risk of non-contact knee injuries, particularly ACL injuries. Intervention 2: Control group: In the control group, volleyball players continued with their regular team training. This group did not undergo any specific intervention related to ACL injury prevention. The control group followed the standard training program as part of their regular daily or weekly schedule without being assigned any specific protocol such as PEP. The control group continued their regular training regimen and participated only in pre-test and post-test assessments for comparison with the intervention group. The main difference between the control group and the intervention group was that the control group did not perform any ACL injury prevention protocol and continued with their usual training routine.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to confidentiality considerations and ethical requirements approved by the Research Ethics Committee, individual participant data (IPD) will not be made publicly available. Only aggregated results and statistical analyses will be reported in the scientific publication.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Morteza Barzegar Bafrouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Evin, Shahid Beheshti University – Faculty of Sport and Health Sciences – Department of Health and Rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 5847</telephone>
        <email>m.barzegar9489@gmail.com</email>
        <affiliation>The University of  Shahid Beheshti</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morteza Barzegar Bafrouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Evin, Shahid Shahriari Square, Shahid Beheshti University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 5847</telephone>
        <email>m.barzegar9489@gmail.com</email>
        <affiliation>The University of Shahid Beheshti</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No history of ACL injury or surgery in the past
No participation in any ACL injury prevention program during the past year
Having 3 to 6 years of training experience</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>20 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Participation in any ACL injury prevention training program or similar program within the past year (such as PEP, FIFA 11+, or Sportsmetrics).
The occurrence of any musculoskeletal injury or condition in the lower extremity during the execution of the protocol that prevents proper implementation of the training protocol.
Inability to consistently adhere to the training protocol or failure to attend post-assessments.
Lack of cooperation in implementing the protocol and discontinuation of participation for any reason.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.512A</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of anterior cruciate ligament of left knee, initial encounter</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: The intervention group will perform the anterior cruciate ligament (ACL) injury prevention program (PEP) three times per week for eight weeks. The program will last approximately 15–20 minutes and will include five components: warm-up, strength, plyometric, agility, and stretching exercises, implemented at the beginning of the main training session as a substitute for the regular warm-up. The aim of this intervention will be to improve neuromuscular control, increase explosive power, enhance dynamic balance, and ultimately reduce the risk of non-contact knee injuries, particularly ACL injuries.</i_keyword>
      <i_keyword>Control group: In the control group, volleyball players continued with their regular team training. This group did not undergo any specific intervention related to ACL injury prevention. The control group followed the standard training program as part of their regular daily or weekly schedule without being assigned any specific protocol such as PEP. The control group continued their regular training regimen and participated only in pre-test and post-test assessments for comparison with the intervention group. The main difference between the control group and the intervention group was that the control group did not perform any ACL injury prevention protocol and continued with their usual training routine.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome variable in this study is agility (9 x 4 meters). It is expected that implementing the PEP training program will produce significant improvements in this variable. Timepoint: The study variables will be measured at two time points: pre-test (before the start of the intervention) and post-test (after the completion of the eight-week training program). Method of measurement: This outcome assesses the agility of athletes through a 9-meter run test in four directions (9 x 4 meters). The aim of this test is to measure reaction speed, rapid change of direction, and muscle coordination. Specifically, the time recorded for running forward and changing direction on this track will be a measure of the athletes' agility.</prim_outcome>
      <prim_outcome>The primary outcome variable in this study includes muscle power (Sargent jump). It is expected that implementing the PEP training program will produce a significant improvement in this variable. Timepoint: The study variables will be measured at two time points: pre-test (before the start of the intervention) and post-test (after the completion of the eight-week training program). Method of measurement: This outcome measures the explosive power of the athlete's lower body muscles through the Sargent Jump Test. In this test, the athlete must jump from a standing position to the highest possible height and record the distance of their jump. The purpose of this test is to measure muscular power and explosive power, which play an important role in sports performance, especially in disciplines such as volleyball.</prim_outcome>
      <prim_outcome>The primary outcome variable in this study is dynamic balance (Y-Balance). It is expected that implementing the PEP exercise program will produce significant improvements in this variable. Timepoint: The study variables will be measured at two time points: pre-test (before the start of the intervention) and post-test (after the completion of the eight-week training program). Method of measurement: This outcome assesses an individual's ability to maintain balance while moving in different directions. In this test, the athlete must maintain balance in three different directions (anterior, posterolateral, and posteromedial) and record their best performance. This test is useful for assessing neuromuscular function and dynamic balance.</prim_outcome>
      <prim_outcome>The primary outcome variable in this study is the Functional Movement Screening (FMS) score. It is expected that implementing the PEP exercise program will produce a significant improvement in this variable. Timepoint: The study variables will be measured at two time points: pre-test (before the start of the intervention) and post-test (after the completion of the eight-week training program). Method of measurement: This outcome is related to the assessment of the quality of functional movements performed using the FMS test. This test consists of seven different movements designed to assess basic movements and the degree of flexibility, strength, and stability of the body. The score of this test indicates the ability of the individual to perform complex movements and correct body function in different sports situations.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Necessary background for conducting the study and field facilities</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-26</approval_date>
        <contact_name>Ethics in Biological Research Working Group, Shahid Beheshti University, Tehran</contact_name>
        <contact_address>Evin, Shahid Shahriari Square, Shahid Beheshti University, Presidency Building, Research Affairs, Office of the Biomedical Research Ethics Committee Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
