<?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>IRCT20180521039762N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-28</date_registration>
      <primary_sponsor>Payame Noor University</primary_sponsor>
      <public_title>Effect of Injury Prevention Exercises on Shoulder Muscle Endurance and Performance in Adolescent Swimmers</public_title>
      <acronym>IPES</acronym>
      <scientific_title>Effect of Localized and Comprehensive Injury Prevention Exercises on Performance, Stability, Upper Limb Function, and Rotator Cuff Muscle Endurance in Adolescent Swimmers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86769</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, simple individual randomization was used. The random sequence was generated using Microsoft Excel with the RAND function. Each participant was randomly assigned to one of three study groups (control, local exercises, comprehensive exercises). For allocation concealment, sealed opaque envelopes were used to ensure that both participants and assessors were unaware of the assigned group, Blinding description: In this study, outcome assessors and data analysts were blinded to group assignments to prevent bias in data collection and analysis. Participants were aware of their assigned group because they needed to receive full information about the intervention. The principal investigator and personnel responsible for administering the exercises were also aware of group assignments. The Data Safety and Monitoring Committee was not involved in this study.</study_design>
      <phase>3</phase>
      <hc_freetext>Shoulder injuries in adolescent swimmers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1 (Local Exercise Group): Participants performed stretching, activation, and strengthening exercises for the shoulder muscles. Each session lasted between 30 to 75 minutes and was conducted three times per week for 8 weeks. Intervention 2: Intervention Group 2 (Comprehensive Exercise Group): In addition to stretching, activation, and strengthening exercises for the shoulder muscles, participants performed exercises for the scapular stabilizing muscles, core muscles, and integrated neuromuscular training. Each session lasted the same duration as Intervention Group 1, and the program was conducted three times per week for 8 weeks. Intervention 3: Control group: Participants only followed their regular weekly swimming routine and did not receive any additional exercise intervention.</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:
After completion of data analysis, de-identified individual participant data—including demographic information and outcomes related to the primary and secondary variables—will be available upon reasonable written request from qualified researchers, subject to approval by the principal investigator. All identifiable information will be removed or anonymized before sharing.

When:
Access to de-identified participant data will be available starting six months after publication of the study results and will remain accessible for five years thereafter.

To whom:
The data will be available to researchers and academic faculty members from universities or research institutions who have a relevant research proposal and obtain approval from an ethics committee.

Conditions:
The data may only be used for scientific and educational research purposes. Data use must align with approved research objectives and have prior ethical committee approval. Applicants are required to submit a research proposal, a data use agreement, and a confidentiality commitment. Any commercial use, unauthorized publication, or analysis beyond the approved scope is strictly prohibited.

Where to obtain:
Requests for access to the data or related documents should be addressed to Dr. Afshin Moghaddasi, Assistant Professor, Payame Noor University.
Postal Address: Payame Noor University, Nakhl Street, Artesh Boulevard, Tehran, Iran, Postal Code: 193954697
Phone: +982122450000
Email: moghadasi@pnu.ac.ir

How to obtain:
The process for requesting data or documents is as follows:
1.The applicant prepares a research proposal along with a data access request form and a confidentiality agreement, and submits them via email to Dr. Afshin Moghaddasi.
2. The request is reviewed by the University Ethics and Research Committee to ensure that the intended use of the data aligns with the study protocol and ethical guidelines.
3. Upon approval, access to the de-identified participant data or requested documents is granted, and the relevant files or download link are sent via email.
4. The entire process typically takes 2 to 4 weeks after receiving the complete request, depending on the data volume and review time.

Comments:
All provided data and documents will be accessible after removing any personally identifiable information of participants. Any use of the data must comply with the approved research objectives, and publication of results should cite the original study. Applicants are also required to adhere to all data protection regulations and maintain confidentiality of the information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afshin Moghadasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payame Noor University, Nakhl Street, Artesh Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۳۹۵۴۶۹۷</zip>
        <telephone>+98 21 2332 0000</telephone>
        <email>moghadasi@pnu.ac.ir</email>
        <affiliation>Payame Noor University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afshin Moghadasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>193954697</zip>
        <telephone>+98 21 2332 0000</telephone>
        <email>moghadasi@pnu.ac.ir</email>
        <affiliation>Payame Noor University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male gender
Adolescent swimmers aged between 10 and 17 years
Amateur participants
Completion and signing of written informed consent form</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>17 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having any disease or injury
History of surgery in the shoulder girdle region</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Shoulder lesions</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1 (Local Exercise Group): Participants performed stretching, activation, and strengthening exercises for the shoulder muscles. Each session lasted between 30 to 75 minutes and was conducted three times per week for 8 weeks.</i_keyword>
      <i_keyword>Intervention Group 2 (Comprehensive Exercise Group): In addition to stretching, activation, and strengthening exercises for the shoulder muscles, participants performed exercises for the scapular stabilizing muscles, core muscles, and integrated neuromuscular training. Each session lasted the same duration as Intervention Group 1, and the program was conducted three times per week for 8 weeks.</i_keyword>
      <i_keyword>Control group: Participants only followed their regular weekly swimming routine and did not receive any additional exercise intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Upper limb stability in the closed kinetic chain; Measured using the Davis test, indicating the ability to control upper limb movements in stable positions. Timepoint: Before the intervention and after the completion of the 8-week exercise intervention. Method of measurement: Measured using the Davis test.</prim_outcome>
      <prim_outcome>Upper limb dynamic stability; Measured using the Y Balance Test, indicating control and coordination of hand and arm movements in multiple directions. Timepoint: Before the intervention and after the completion of the 8-week exercise intervention. Method of measurement: Measured using the Y Balance Test.</prim_outcome>
      <prim_outcome>Rotator cuff muscle endurance; Measured using the repetitive external shoulder rotation test with dumbbells, indicating the ability of muscles to perform repeated activity. Timepoint: Before the intervention and after the completion of the 8-week exercise intervention. Method of measurement: Measured using the repetitive external shoulder rotation test with dumbbells.</prim_outcome>
      <prim_outcome>Front crawl performance; Measured using the 50-meter front crawl time, number of strokes, and stroke-to-time ratio, indicating overall swimming performance. Timepoint: Before the intervention and after the completion of the 8-week exercise intervention. Method of measurement: Measured using 50-meter front crawl time, number of strokes, and stroke-to-time ratio.</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>Payame Noor University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-16</approval_date>
        <contact_name>Ethics Committee of Payame Noor University</contact_name>
        <contact_address>Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
