<?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>IRCT20230622058558N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-02</date_registration>
      <primary_sponsor>Razi University</primary_sponsor>
      <public_title>The effect of caffeine on anaerobic performance and fatigue caused by it</public_title>
      <acronym></acronym>
      <scientific_title>The effect of different doses of caffeine  consumption on EMG activity variables and muscle fatigue index in response to maximal anaerobic test in healthy women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70926</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Blinding description: In each test session, two subjects are present in the laboratory and tablets containing different doses of caffeine in the same dimensions and shapes are given to the subjects by a person other than the subjects and the researcher who knows the dose of the tablets, and the number It records the session and dosage of each subject with date and time. Then, by performing the test protocol, the information is collected and recorded by the researcher. After the completion of all four test sessions and data analysis based on session number and date, each data is attributed to its respective dose.</study_design>
      <phase>1-2</phase>
      <hc_freetext>This study is conducted on healthy women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In this research, all the subjects will complete three test sessions (with ten days intervals) in the laboratory by consuming three doses of low, medium and high caffeine. The test protocol is completely similar in all sessions, and each subject is required to perform three 30-second test sessions with 4-minute rest intervals. During the test, the amount of muscle contractions of the right thigh muscles and the lateral width of their upper leg is measured and recorded by an electromyography device. Also, after performing the three-step Wingate test, the maximum voluntary contraction of the muscles mentioned above is measured with rest intervals of 5, 10, 15 and 30 minutes. Intervention 2: Control group: In this research, all the subjects participate in a control session with a pill containing a placebo in addition to the three intervention sessions. All the details of the implementation of the protocol in the control mode will be similar to the intervention mode, with the difference that in the control mode, a tablet containing an ineffective substance (dextrose) will be given to the subjects.</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 upon official request

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

Where to obtain:
If you need to receive documents, send an email to Seyyed Hakime Hosseini Moghadam, with the email address: hakime.hosainimoghadam@gmail.com.

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

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyde Hakime Hosseinimoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th floor, Unit 8, No. 6, Arshaya Building, 12th west of Shahid Habibi Moghadam, Rajaee Shahr, Elkhebal Blvd.</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3147646617</zip>
        <telephone>+98 26 3435 5047</telephone>
        <email>hakime.hosainimoghadam@gmail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Worya Tahmasebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bagh Abrisham, Razi University, Faculty of Sports Sciences</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3147646617</zip>
        <telephone>+98 83 3427 4511</telephone>
        <email>hakime.hosainimoghadam@gmail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18 to 30 years
No vigorous exercise 48 hours before the test
No use of tobacco, no use of medicine
Obtaining a certificate of non-prohibition of participation in sports training program from the doctor
Acquaintance and implementation of anaerobic exercises
Body mass index (BMI) 18.5 to 24.9 kg per square meter of height</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Suffering from various cardiovascular, pulmonary and metabolic diseases
History of seizures, epilepsy or other types of neurological diseases
The presence of implantable devices or pacemakers in the body
Use of drugs or psychotropic substances and alcoholic beverages</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>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In this research, all the subjects will complete three test sessions (with ten days intervals) in the laboratory by consuming three doses of low, medium and high caffeine. The test protocol is completely similar in all sessions, and each subject is required to perform three 30-second test sessions with 4-minute rest intervals. During the test, the amount of muscle contractions of the right thigh muscles and the lateral width of their upper leg is measured and recorded by an electromyography device. Also, after performing the three-step Wingate test, the maximum voluntary contraction of the muscles mentioned above is measured with rest intervals of 5, 10, 15 and 30 minutes.</i_keyword>
      <i_keyword>Control group: In this research, all the subjects participate in a control session with a pill containing a placebo in addition to the three intervention sessions. All the details of the implementation of the protocol in the control mode will be similar to the intervention mode, with the difference that in the control mode, a tablet containing an ineffective substance (dextrose) will be given to the subjects.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in anaerobic performance. Timepoint: During and after each 30-second Wingate test. Method of measurement: Using the standard Wingate 30 second lower body test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The maximum amount of voluntary contraction. Timepoint: After three 30-second Wingate tests with 5, 10, 15, and 30 minute rest intervals. Method of measurement: 16-channel wireless electromyography.</sec_outcome>
      <sec_outcome>Pressure. Timepoint: During and after each lower body Wingate test. Method of measurement: Using the 6-20 Borg pressure perception scale.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-18</approval_date>
        <contact_name>Razi University Research Ethics Committee</contact_name>
        <contact_address>Room 73, Faculty of Sports Sciences, Razi University, University Street, Taqbestan, Kermanshah,Iran Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
