<?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>IRCT20191214045729N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-24</date_registration>
      <primary_sponsor>The University of Tehran</primary_sponsor>
      <public_title>Comparing the effects of local, functional, and mental fatigue protocols on muscle strength, balance and performance in healthy athletes and with anterior cruciate ligament reconstruction.</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of local, functional, and mental fatigue protocols on isokinetic strength, balance, and performance in healthy athletes and with anterior cruciate ligament reconstruction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83471</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anterior Cruciate Ligament Reconstruction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group one: Local fatigue: To induce localized fatigue, the Biodex isokinetic dynamometer (System 4 Pro™ model) will be used. In this experiment, each participant will undergo six test stages. The first three stages involve determining the maximum torque at three angular velocities: 60, 180, and 300 degrees per second. The criterion for achieving fatigue at each speed is a reduction in torque to below 50% of the individual's maximal voluntary torque at that specific speed. Intervention 2: Intervention group two: Functional fatigue : To induce functional fatigue, a functional agility short-term fatigue protocol will be used. This protocol consists of the following four components:    Step-up    L-drill    Countermovement jump    Agility ladder drill. Based on previous studies, participants are required to complete all four sets of the protocol consecutively in order to induce a state of fatigue. The entire sequence is estimated to last approximately six minutes. Intervention 3: Intervention group three: Mental fatigue: The mental fatigue protocol will be conducted using the Stroop test.To induce mental fatigue, a 30-minute Stroop task will be employed. The Stroop mental fatigue task is essentially a color-word interference test administered during the mental fatigue session. In this task, color words ("red," "blue," "green," and "yellow") are presented on a screen in either congruent or incongruent formats.Participants are encouraged to exert maximal effort to complete as many items as possible within the 30-minute period.The Stroop task will be administered using the DMDX software on the same display and at the same distance.</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:
All data can be shared after de-identifying individuals.

When:
The access period begins 8 months after the results are published.

To whom:
The data is accessible to all scientific and industrial people.

Conditions:
The data is accessible to all scientific and industrial people.

Where to obtain:
To receive the data, they can apply to the following email address:
m.hamzeh13755@ut.ac.ir
Also, they can contact Mohammad Hamzeh at the following number:
00989138790757

How to obtain:
After sending the applicant's email and code assigned to the subject at the time of testing, his data will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Hamzeh Shalamzari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955975</zip>
        <telephone>+98 21 6111 8928</telephone>
        <email>m.hamzeh13755@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hooman Minoonejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955975</zip>
        <telephone>+98 21 6111 8928</telephone>
        <email>h.minoonejad@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The samples were from athletes in sports with shearing, jumping, and landing movement patterns who had regular sports activity and at least 3 years of experience.
The mechanism of ACL injury is non-contact and occurs in jumping and landing movement patterns or shearing movements.
The surgical procedure is anterior cruciate ligament reconstruction with hamstring autograft.
Have completed various levels of rehabilitation and rehabilitation courses.
The physical activity level of individuals after the rehabilitation process and return to sports should be a score of 6 or higher based on the Tigner questionnaire.
Full range of motion in knee flexion and extension movements
Body mass index between 18 - 25</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Any neurological, cardiovascular, metabolic, rheumatic or vestibular disease.
Frequent use of painkillers and drugs that affect the person's balance
Consumption of any caffeine, energy drinks, or alcohol 24 hours before performing the fatigue protocol
Performing intense physical activity 24 hours before the implementation of the fatigue protocol
Having any history of injury or surgery to the hip, ankle, foot, or opposite knee injury
Having any mental health problems, such as depression or anxiety</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group one: Local fatigue: To induce localized fatigue, the Biodex isokinetic dynamometer (System 4 Pro™ model) will be used. In this experiment, each participant will undergo six test stages. The first three stages involve determining the maximum torque at three angular velocities: 60, 180, and 300 degrees per second. The criterion for achieving fatigue at each speed is a reduction in torque to below 50% of the individual's maximal voluntary torque at that specific speed.</i_keyword>
      <i_keyword>Intervention group two: Functional fatigue : To induce functional fatigue, a functional agility short-term fatigue protocol will be used. This protocol consists of the following four components:    Step-up    L-drill    Countermovement jump    Agility ladder drill. Based on previous studies, participants are required to complete all four sets of the protocol consecutively in order to induce a state of fatigue. The entire sequence is estimated to last approximately six minutes.</i_keyword>
      <i_keyword>Intervention group three: Mental fatigue: The mental fatigue protocol will be conducted using the Stroop test.To induce mental fatigue, a 30-minute Stroop task will be employed. The Stroop mental fatigue task is essentially a color-word interference test administered during the mental fatigue session. In this task, color words ("red," "blue," "green," and "yellow") are presented on a screen in either congruent or incongruent formats.Participants are encouraged to exert maximal effort to complete as many items as possible within the 30-minute period.The Stroop task will be administered using the DMDX software on the same display and at the same distance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quadriceps to hamstring strength ratio. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 and 21 days after the start of the study (after each fatigue protocol applied at 7-day intervals). Method of measurement: Isokinetic.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knee Flexion and Extensor Peak Torque. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 and 21 days after the start of the study (after each fatigue protocol applied at 7-day intervals). Method of measurement: Isokinetic.</sec_outcome>
      <sec_outcome>Landing performance. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 and 21 days after the start of the study (after each fatigue protocol applied at 7-day intervals). Method of measurement: Landing Error Scoring System.</sec_outcome>
      <sec_outcome>Joint Position Sense. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 and 21 days after the start of the study (after each fatigue protocol applied at 7-day intervals). Method of measurement: Isokinetic.</sec_outcome>
      <sec_outcome>Postural Stability. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 and 21 days after the start of the study (after each fatigue protocol applied at 7-day intervals). Method of measurement: Biodex Balance System.</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>The University of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-11</approval_date>
        <contact_name>Research Ethics Committees of Tehran University - Faculty of Sport Sciences and Health</contact_name>
        <contact_address>Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
