<?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>IRCT20230708058720N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-13</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of caffeine and warming up in sprinters</public_title>
      <acronym></acronym>
      <scientific_title>Effects of adding total motion release technique to caffeine ingestion on neuromuscular, cognitive and anaerobic performance in male sprinters</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71440</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants use the simple randomization technique with the Spin the wheel Picker decides software on mobile, which is available from Google Play with the link https://play.google.com/store/apps/details?id=com.randompicker.wheeldecides.randomnamepicker .spinthewheel was received, randomly placed into 4 groups. Allocation was determined through a random sequence. 4 indicators of 4 groups were entered in the software and the button was started when the person was present. Since the number of people in each group was considered to be 14 people, the chance of choosing people in the groups was the same. For each person, one of the numbers 1-4 was shown on the screen, which indicated the group and thus their type of intervention, Blinding description: People were evaluated without a detailed explanation about the type of pill they were taking, and without contacting each other, and they did not know about other people's interventions.
Rest time of 40 or 60 minutes was applied according to grouping and individual people were evaluated.</study_design>
      <phase>3</phase>
      <hc_freetext>Cognition, Functional Movement Screen, Total Motion Release, TMR, Wingate anaerobic.</hc_freetext>
      <i_freetext>Intervention 1: Control group: this group of participants at the beginning of the triple evaluation work (including two cognitive tests Stroop and Eriksen Flanker with a laptop in the offline version, a neuromuscular 7 movement test called FMS with the help of the Anham kit for this test, a Wingate's anaerobic test is performed with the help of Technogym's hand bike. Then according to the group in which they have been placed according to randomization (control), a tablet containing cellulose as a placebo and ineffective, manufactured by Karen Company, is consumed with a glass of water. Then, in the next step, they rest for 1 hour. In the next stage, all the evaluations of the first stage will be taken from the participants again.The duration of the meeting is generally 1.5 hours, including two 15-minute evaluations and 1 hour of rest, and the venue is at the Sports Medicine Federation. Intervention 2: Intervention group:  This group of participants performs triple evaluations at the beginning of the work (including two cognitive tests with a laptop, a neuromuscular 7 movement test called FMS, and a Wingate anaerobic test with the help of a hand bike). Then according to the randomization group (caffeine), they consume a tablet containing 200 mg of caffeine, made by Karen company, with a glass of water. Then, in the next step, they rest for an hour so that the caffeine has its maximum effectiveness. After this break, all the evaluations of the first stage will be taken from the people again.The duration of the session is generally 1.5 hours, including two 15-minute evaluations and 1 hour of pill effect time, and the venue is at the Sports Medicine Federation. Intervention 3: Intervention group: This group of participants performs triple evaluations at the beginning of the work (including two cognitive tests with a laptop, a neuromuscular 7 movement test called FMS, and a Wingate anaerobic test with the help of a hand bike). Then according to the group they are placed in according to randomization (TMR), they consume a tablet containing cellulose, made by Karen company, which acts as an ineffective placebo, with a glass of water. Then, in the next step, they rest for 40 minutes. This time is due to the fact that the TMR warm-up process takes about 20 minutes and generally, similar to other groups, there is an interval of 1 hour between the two assessment stages. After this rest, subjects are asked to perform 6 TMR movements for each side for 2 sets of 15, with 30 seconds of rest between each set and 1 minute of rest between each movement. In the next stage, all the evaluations of the first stage will be taken from the participants again. The duration of the session is generally 1.5 hours, including two 15-minute evaluations and 1 hour of rest and exercise in between, and the venue is at the Sports Medicine Federation. Intervention 4: Intervention group: This group of participants performs triple evaluations at the beginning of the work (including two cognitive tests with a laptop, a neuromuscular 7 movement test called FMS, and a Wingate anaerobic test with the help of a hand bike). Then according to the randomization group (caffeine + TMR), a tablet containing 200 mg of caffeine, manufactured by Karen, is consumed with a glass of water. Then, in the next step, they rest for 40 minutes. This time is due to the fact that the TMR warm-up process takes about 20 minutes and generally, similar to other groups, there is an interval of 1 hour between the two assessment stages. After this rest, subjects are asked to perform 6 TMR movements for each side for 2 sets of 15, with 30 seconds of rest between each set and 1 minute of rest between each movement. In the next stage, all the evaluations of the first stage will be taken from the participants again.The duration of the meeting is generally 1.5 hours, including two 15-minute evaluations and 1 hour of rest for the effectiveness of the pill and exercise, and the venue is at the Sports Medicine Federation.</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:
The data of this study will be placed in the form of 56 separate participants, each of which has 28 variables. 14 cases of interventions are related to the first stage of evaluation and 14 cases are related to the second stage of evaluation.

When:
The access period starts after the results are printed

To whom:
Those interested in the field of physiotherapy and sports and sports nutrition, other enthusiastic researchers

Conditions:
The use of data is unimpeded by mentioning the source

Where to obtain:
Email below
p_safapour@razi.tums.ac.ir

How to obtain:
Email below
p_safapour@razi.tums.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parsa Safapour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 24, Mostali Ave., N. Kargar St., Enghelab Sq., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1418814371</zip>
        <telephone>+98 21 6693 7407</telephone>
        <email>p_safapour@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parsa Safapour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 24, Mostali Ave., N. Kargar St., Enghelab Sq., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1418814371</zip>
        <telephone>+98 21 6693 7407</telephone>
        <email>p_safapour@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Semi-professional sprinter men aged 18-40
No history of musculoskeletal injury in the past 3 months
Not consuming caffeine, cigarettes and alcohol at least 48 hours before the research
No history of neurological disease or balance disorder
Absence of cardiovascular and metabolic problems</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Allergy to caffeine
People's unwillingness to continue the research process
Nervous, kidney or stomach reflux problems
Incomplete range of motion in bilateral comparison</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: this group of participants at the beginning of the triple evaluation work (including two cognitive tests Stroop and Eriksen Flanker with a laptop in the offline version, a neuromuscular 7 movement test called FMS with the help of the Anham kit for this test, a Wingate's anaerobic test is performed with the help of Technogym's hand bike. Then according to the group in which they have been placed according to randomization (control), a tablet containing cellulose as a placebo and ineffective, manufactured by Karen Company, is consumed with a glass of water. Then, in the next step, they rest for 1 hour. In the next stage, all the evaluations of the first stage will be taken from the participants again.The duration of the meeting is generally 1.5 hours, including two 15-minute evaluations and 1 hour of rest, and the venue is at the Sports Medicine Federation.</i_keyword>
      <i_keyword>Intervention group:  This group of participants performs triple evaluations at the beginning of the work (including two cognitive tests with a laptop, a neuromuscular 7 movement test called FMS, and a Wingate anaerobic test with the help of a hand bike). Then according to the randomization group (caffeine), they consume a tablet containing 200 mg of caffeine, made by Karen company, with a glass of water. Then, in the next step, they rest for an hour so that the caffeine has its maximum effectiveness. After this break, all the evaluations of the first stage will be taken from the people again.The duration of the session is generally 1.5 hours, including two 15-minute evaluations and 1 hour of pill effect time, and the venue is at the Sports Medicine Federation.</i_keyword>
      <i_keyword>Intervention group: This group of participants performs triple evaluations at the beginning of the work (including two cognitive tests with a laptop, a neuromuscular 7 movement test called FMS, and a Wingate anaerobic test with the help of a hand bike). Then according to the group they are placed in according to randomization (TMR), they consume a tablet containing cellulose, made by Karen company, which acts as an ineffective placebo, with a glass of water. Then, in the next step, they rest for 40 minutes. This time is due to the fact that the TMR warm-up process takes about 20 minutes and generally, similar to other groups, there is an interval of 1 hour between the two assessment stages. After this rest, subjects are asked to perform 6 TMR movements for each side for 2 sets of 15, with 30 seconds of rest between each set and 1 minute of rest between each movement. In the next stage, all the evaluations of the first stage will be taken from the participants again. The duration of the session is generally 1.5 hours, including two 15-minute evaluations and 1 hour of rest and exercise in between, and the venue is at the Sports Medicine Federation.</i_keyword>
      <i_keyword>Intervention group: This group of participants performs triple evaluations at the beginning of the work (including two cognitive tests with a laptop, a neuromuscular 7 movement test called FMS, and a Wingate anaerobic test with the help of a hand bike). Then according to the randomization group (caffeine + TMR), a tablet containing 200 mg of caffeine, manufactured by Karen, is consumed with a glass of water. Then, in the next step, they rest for 40 minutes. This time is due to the fact that the TMR warm-up process takes about 20 minutes and generally, similar to other groups, there is an interval of 1 hour between the two assessment stages. After this rest, subjects are asked to perform 6 TMR movements for each side for 2 sets of 15, with 30 seconds of rest between each set and 1 minute of rest between each movement. In the next stage, all the evaluations of the first stage will be taken from the participants again.The duration of the meeting is generally 1.5 hours, including two 15-minute evaluations and 1 hour of rest for the effectiveness of the pill and exercise, and the venue is at the Sports Medicine Federation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional Movement Screen. Timepoint: Measuring functional movement screening score in the initial study and after taking the pill and performing the complete movement warm-up technique. Method of measurement: FMS toolkit.</prim_outcome>
      <prim_outcome>Cognition Tests. Timepoint: Evaluation of cognitive functions by Eriksen Flanker and Stroop tests at the beginning of the study and after taking the pill and performing the complete movement warm-up technique. Method of measurement: Eriksen Flanker Task and Stroop test with laptop.</prim_outcome>
      <prim_outcome>Wingate Anaerobic Test. Timepoint: Anaerobic test evaluation by Wingate test at the beginning of the study and after taking the pill and performing full movement warm-up technique. Method of measurement: Technogym Bike anaerobic test.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-04</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery &amp; Rehabilitation - Tehran University o</contact_name>
        <contact_address>No. 24, Mostali Ave., N. Kargar, Enghelab Sq. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
