<?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>IRCT20160523028028N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-14</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of neuromuscular exercises with the use of clemzinc supplements in taekwondo athletes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of neuromuscular training with Cal/Mag/Zinc Complex on preventing ankle and knee injuries, balance and electromyography activity of the muscles, reaction time and electromechanical delay of taekwondo athletes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73591</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Other, Randomization description: Random allocation by a person not involved in the research using RAS (Random Allocation Software) and random block using blocks of four and eight for allocation in four groups. Three intervention groups and one control group will be produced. Allocation concealment will be done based on the sequence produced using opaque, sealed envelopes, numbered from 1 to the end. The first person who enters the study will be given envelope number 1 and this process will continue until the end. Therefore, the researcher and the research subject will not know about the type of allocation received (Allocation Concealment) until after the envelopes are opened. Both athletes and their coaches will be blinded to the initial results of the changes.</study_design>
      <phase>3</phase>
      <hc_freetext>ankle and foot injuries.</hc_freetext>
      <i_freetext>Intervention 1: They will do the protocol three times a week for about 60 minutes for 6 weeks. Each training session will include 5 exercises. Neuromuscular training will be provided one hour before regular training (i.e. mobility and strength training; usually four sessions per week, duration of 120 minutes each session) for the mentioned groups under the supervision of an athletic trainer. Then all the groups will do their usual exercises at the specified time from 18:00 to 20:00. In addition, the perceived intensity of the 15-17 neuromuscular training sessions will be based on the Borg scale (scores from 6 to 20) based on individual monitoring in the groups. Intervention 2: Intervention group: NMT+Cal-Mg-Zinc: Athletes participating in neuromuscular+colmegezinc supplement will perform the protocol for about 60 minutes three times a week for 6 weeks. Each training session will include 5 exercises (one exercise for each category listed in Table 1). Neuromuscular training will be provided one hour before regular training (i.e. mobility and strength training; usually four sessions per week, duration of 120 minutes each session) for the mentioned groups under the supervision of an athletic trainer. Then all the groups will do their usual exercises at the specified time from 18:00 to 20:00. In addition, the perceived intensity of the 15-17 neuromuscular training sessions will be based on the Borg scale (scores from 6 to 20) based on individual monitoring in the groups. Taekwondo athletes should take 2 calcium-magnesium-zinc supplements (1 in the morning and 1 in the evening) during the day. Adherence to the study drugs will be confirmed by counting the pills returned every day of training. During the study, participants will be asked to fill out an adverse event diary and contact the team's healthcare provider. The participants will have an initial interview about their lifestyle habits and medical history and they will be asked about their food habits for three days (Saturday, Sunday and Wednesday) and they will also be advised to avoid taking similar supplements or substances. Avoid food with minerals similar to the study food supplement. Intervention 3: Control group: At the same time, the control group (CG) will perform their usual Taekwondo training (ie, mobility and strength training; usually four sessions per week, each training session lasts 120 minutes) at the specified time of 18:00 to 20:00. Intervention 4: Control+Cal-Mg-Zinc:At the same time, the control group + clemgyzinc supplementation will perform their usual Taekwondo training (ie, mobility and strength training; usually four sessions per week, each training session lasts 120 minutes) at the specified time of 18:00 to 20:00. Taekwondo athletes should take 2 calcium-magnesium-zinc supplements (1 in the morning and 1 in the evening) during the day. Adherence to the study drugs will be confirmed by counting the pills returned every day of training. During the study, participants will be asked to fill out an adverse event diary and contact the team's healthcare provider. The participants will have an initial interview about their lifestyle habits and medical history and they will be asked about their food habits for three days (Saturday, Sunday and Wednesday) and they will also be advised to avoid taking similar supplements or substances. Avoid food with minerals similar to the study food supplement.</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:
Data collection will be done by the researchers and information about the main outcomes of the study will be published.

When:
Access to the data will be possible immediately after the results are printed.

To whom:
The general public, athletes and researchers

Conditions:
Reviewers of magazines and Azerbaijan University of Medical Sciences and Shahid Madani are allowed to send requests to receive non-identifiable personal data or other documents. Until the publication of the results in the form of an article, it is not allowed to perform statistical analysis on the delivered data.

Where to obtain:
Dr. Azam Zarneshan
email: baraziliya@gmail.com

How to obtain:
via email to corresponding author: Dr. Azam Zarnashan
baraziliya@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam zarneshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>goolgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5155673964</zip>
        <telephone>+98 61 4254 5997</telephone>
        <email>baraziliya@gmail.com</email>
        <affiliation>Shahid madani university, Azaruniv</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam zarneshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>goolgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5155673964</zip>
        <telephone>+98 914 254 5997</telephone>
        <email>barazikiya@gmail.com</email>
        <affiliation>Azaruniv</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 6 years of Taekwondo practice.
Regular Taekwondo training and competition for 6 months prior to data collection
No injuries in the last three months
Non-participation in other neuromuscular exercises or diet outside of this study</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>20 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Injury during training
Absence of three or more training sessions during the study
Absence on a test day</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S90.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified superficial injury of ankle, foot and toe</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>They will do the protocol three times a week for about 60 minutes for 6 weeks. Each training session will include 5 exercises. Neuromuscular training will be provided one hour before regular training (i.e. mobility and strength training; usually four sessions per week, duration of 120 minutes each session) for the mentioned groups under the supervision of an athletic trainer. Then all the groups will do their usual exercises at the specified time from 18:00 to 20:00. In addition, the perceived intensity of the 15-17 neuromuscular training sessions will be based on the Borg scale (scores from 6 to 20) based on individual monitoring in the groups.</i_keyword>
      <i_keyword>Intervention group: NMT+Cal-Mg-Zinc: Athletes participating in neuromuscular+colmegezinc supplement will perform the protocol for about 60 minutes three times a week for 6 weeks. Each training session will include 5 exercises (one exercise for each category listed in Table 1). Neuromuscular training will be provided one hour before regular training (i.e. mobility and strength training; usually four sessions per week, duration of 120 minutes each session) for the mentioned groups under the supervision of an athletic trainer. Then all the groups will do their usual exercises at the specified time from 18:00 to 20:00. In addition, the perceived intensity of the 15-17 neuromuscular training sessions will be based on the Borg scale (scores from 6 to 20) based on individual monitoring in the groups. Taekwondo athletes should take 2 calcium-magnesium-zinc supplements (1 in the morning and 1 in the evening) during the day. Adherence to the study drugs will be confirmed by counting the pills returned every day of training. During the study, participants will be asked to fill out an adverse event diary and contact the team's healthcare provider. The participants will have an initial interview about their lifestyle habits and medical history and they will be asked about their food habits for three days (Saturday, Sunday and Wednesday) and they will also be advised to avoid taking similar supplements or substances. Avoid food with minerals similar to the study food supplement.</i_keyword>
      <i_keyword>Control group: At the same time, the control group (CG) will perform their usual Taekwondo training (ie, mobility and strength training; usually four sessions per week, each training session lasts 120 minutes) at the specified time of 18:00 to 20:00.</i_keyword>
      <i_keyword>Control+Cal-Mg-Zinc:At the same time, the control group + clemgyzinc supplementation will perform their usual Taekwondo training (ie, mobility and strength training; usually four sessions per week, each training session lasts 120 minutes) at the specified time of 18:00 to 20:00. Taekwondo athletes should take 2 calcium-magnesium-zinc supplements (1 in the morning and 1 in the evening) during the day. Adherence to the study drugs will be confirmed by counting the pills returned every day of training. During the study, participants will be asked to fill out an adverse event diary and contact the team's healthcare provider. The participants will have an initial interview about their lifestyle habits and medical history and they will be asked about their food habits for three days (Saturday, Sunday and Wednesday) and they will also be advised to avoid taking similar supplements or substances. Avoid food with minerals similar to the study food supplement.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ankle and knee injuries. Timepoint: Before the intervention and six weeks after the intervention. Method of measurement: self report.</prim_outcome>
      <prim_outcome>Balance and muscle Electromyographyactivity. Timepoint: Before and three and six weeks after the intervention. Method of measurement: EMG, Balance test.</prim_outcome>
      <prim_outcome>Reaction time and electronically delay. Timepoint: Before and three and six weeks after the intervention. Method of measurement: EMG, speed.</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>TBZMED</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-05</approval_date>
        <contact_name>دانشگاه علوم پزشکی تبریز</contact_name>
        <contact_address>goolgasht Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
