<?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>IRCT20230629058614N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-20</date_registration>
      <primary_sponsor>Razi University of Kermanshah</primary_sponsor>
      <public_title>The effects of  acute non-invasive brain stimulation on cognitive and executive functions in one bout of exhaustive endurance activity in semi-endurance runners</public_title>
      <acronym>ETDCSESER</acronym>
      <scientific_title>The effects of  acute non-invasive brain stimulation on cognitive and executive functions in one bout of exhaustive endurance activity in semi-endurance runners</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>18</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71650</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Other, Randomization description: Randomization method and description of each method: simple randomization, block
(Subjects will be cross-exposed to two brain stimulation conditions including 1) DLPFC anodal stimulation and 2) sham stimulation.), Blinding description: Subjects and the main researcher will not be aware of the type of stimulation received in each session, and this information will only be available to someone outside the research team until the end of the research. In order to hide the order of receiving stimulation from the main researcher, all the steps related to the random determination of the order of receiving stimulation in each subject will be performed by the same person outside the research team. Also, in order to hide the type of stimulation in each session from the subjects, the TDCS device is hidden from the eyes of the subjects with a mask and the main researcher will not be present in the laboratory during the installation of the electrodes and at the end of 20 minutes and the time of removing the electrodes.</study_design>
      <phase>3</phase>
      <hc_freetext>The effect of acute non-invasive brain stimulation on cognitive and executive functions in a single bout of endurance exercise..</hc_freetext>
      <i_freetext>Intervention group: 14 adult semi-endurance male runners, members of the Kermanshah athletics team. The first session will be used to familiarize the subjects with the research process, the method of applying interventions and measuring variables and primary measurements. Then the subjects will be present in the laboratory in 3 separate sessions with an interval of at least 5 days between the sessions. The second session will be for the purpose of measuring the maximum aerobic speed and the next two sessions will be for the purpose of applying interventions and measuring the desired variables. in the third and fourth sessions; Subjects will be randomly exposed to two types of brain stimulation for 20 minutes, including 1) anodal stimulation of the left posterolateral prefrontal cortex (DLPFC) and 2) sham stimulation..</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 subjects.

When:
3 months after printing the results

To whom:
All people if they submit an official request

Conditions:
Requesting access to data for any purpose is permitted.

Where to obtain:
If you need to receive documents, contact Mehdi Esmaeili, a master's student at Razi University of Kermanshah, by email: m.esmaeili.2911@gmail.com.

How to obtain:
In case of submitting an official request, announcing the relevant reasons and mentioning the complete details, the data will be announced via email after 72 hours.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi esmaili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences, Razi University, Taq Bostan, University St., Kermanshah, Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3836 2077</telephone>
        <email>m.esmaeili.2911@gmail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi esmaili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences, Razi University, University St., Taq Bostan, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3845 8428</telephone>
        <email>m.esmaeili.2911@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1) More than 3 years of active experience in the field of endurance biathlon
2) Age range from 18 to 35 years
3) Body mass index (BMI) 18.5 to 24.9 kilograms per square meter of height
4) Not suffering from color blindness or color vision disorders
5) Being right-handed</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>1) Suffering from any cardiovascular, pulmonary and metabolic diseases
2) history of seizures, epilepsy or other types of neurological diseases
3) The presence of implantable devices or pacemakers in the body
4) Smoking and alcohol consumption</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 14 adult semi-endurance male runners, members of the Kermanshah athletics team. The first session will be used to familiarize the subjects with the research process, the method of applying interventions and measuring variables and primary measurements. Then the subjects will be present in the laboratory in 3 separate sessions with an interval of at least 5 days between the sessions. The second session will be for the purpose of measuring the maximum aerobic speed and the next two sessions will be for the purpose of applying interventions and measuring the desired variables. in the third and fourth sessions; Subjects will be randomly exposed to two types of brain stimulation for 20 minutes, including 1) anodal stimulation of the left posterolateral prefrontal cortex (DLPFC) and 2) sham stimulation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in bimanual coordination. Timepoint: Measurement of bimanual coordination at the beginning of the study in the first week (before the start of the intervention), measurement of bimanual coordination 20 minutes after stimulation, measurement of bimanual coordination one week after the first intervention and before the sham intervention in the second week, measurement Bimanual coordination 20 minutes after sham intervention (unrealistic stimulation) in the second week. Method of measurement: Lafayette company's two-handed coordination tool.</prim_outcome>
      <prim_outcome>Reaction Time. Timepoint: Measurement of reaction time at the beginning of the study in the first week (before the start of the intervention), measurement of reaction time 20 minutes after stimulation, measurement of reaction time one week after the first intervention and before sham intervention in the second week, measurement of reaction time 20 minutes after From sham intervention (unreal stimulation) in the second week. Method of measurement: Reaction time device Response Panel (63035A, Lafayette, Indiana).</prim_outcome>
      <prim_outcome>Working memory. Timepoint: Measurement of working memory at the beginning of the study in the first week (before the start of the intervention), measurement of working memory 20 minutes after stimulation, measurement of working memory one week after the first intervention and before sham intervention in the second week, measurement of working memory 20 minutes After sham intervention (unreal stimulus) in the second week. Method of measurement: Stroop word-color test.</prim_outcome>
      <prim_outcome>Rate of perceived pressure (RPE). Timepoint: During the execution of sub-maximal endurance activity, every 3 minutes, the level of perceived pressure is announced and recorded by the subjects. The average pressure perception in each training session is calculated and used for analysis. Method of measurement: From the image of the Borg scale (0 – 100; RPE).</prim_outcome>
      <prim_outcome>Feeling scale to measure the feeling of pleasure (perceptual response). Timepoint: During the performance of the sub-maximal endurance activity, every 3 minutes the level of pleasure is declared and recorded by the subjects. The average level of pleasure in each training session is calculated and used for analysis. Method of measurement: An 11-item emotion scale is used, the answers of which are recorded and analyzed in the range of +5 to -5.</prim_outcome>
      <prim_outcome>Visual analog scale to measure pain sensation. Timepoint: During the performance of sub-maximal endurance activity, the pain level is declared and recorded by the subjects every 3 minutes. The average level of pain sensation in each training session is calculated and used for analysis. Method of measurement: A 0-10 visual analog scale is used to measure pain.</prim_outcome>
      <prim_outcome>Perceived arousal scale to measure arousal (perceptual response). Timepoint: During the performance of submaximal endurance activity, the level of arousal is announced and recorded by the subjects every 3 minutes. The average level of arousal in each training session is calculated and used for analysis. Method of measurement: A 6-item scale of perceived arousal is used.</prim_outcome>
      <prim_outcome>Countdown cognitive test. Timepoint: During the performance of the endurance activity, when the subject reaches the pressure perception level of 70 on the Borg scale, a countdown cognitive test will be performed. Method of measurement: During the performance of the endurance activity, in the 4th, 8th and 12th kilometers, a number from 200 to 300 will be randomly announced by the test taker and the test taker will be asked to say loudly for 1 minute. Count backwards and with a distance of 3 from the announced number, then the total number of numbers read by the subject and the number of correct numbers from the total numbers are calculated and used for analysis.</prim_outcome>
      <prim_outcome>اندازه گیری ضربان قلب در حین اجرای فعالیت استقامتی. Timepoint: During the performance of sub-maximal endurance activity, the heart rate is announced and recorded by the subjects every 3 minutes. The average heart rate in each training session is calculated and used for analysis. Method of measurement: Polar heart rate monitor (made in Finland).</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>Razi University of Kermanshah</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-10</approval_date>
        <contact_name>Ethics Committee of Razi University</contact_name>
        <contact_address>Kermanshah, Taq Bostan, University St., Razi University, Deputy Research Area Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
