<?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>IRCT20190702044080N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-30</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Selected Mod of Physical Activity During Shift Work on Cardiovascular Biomarkers in Sarirplast Industrial Group Workers</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Selected Mod of Physical Activity During Shift Work on Cardiovascular Biomarkers in Sarirplast Industrial Group Workers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40598</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The volunteer candidates will be selected by targeted sampling. For shift workers, a random number will be assigned an identification number. So a range of 00 to 29 will be determined. Two equal groups (n = 15) will be formed. The samples will be divided into intervention and control groups using random numbers. The first number entered into the intervention group and the second to the control group; this process will continue to accommodate 15 individuals in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiovascular biomarkers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: According to the World Health Organization's recommendation for weight adjustment and risk reduction of cardiovascular disease, physical activity with moderate intensity  is determined for intervention group. Intervention is conducted 3 days a week with  a day rest  between sessions and for 8 weeks at 17-19 pm. Each session consists of 10 minutes of warm-up (running and stretching), 30 minutes of running, and 5 to 7 minutes of cool-down (running and stretching) with the examiner's supervision. To observe the principle of over-load, the physical activity of the intervention group starts at 50% of the Target Heart Rate and will reach 70% in the final weeks. The activity is controlled by the beaconometer. So high-fatty foods (especially for shimmering) will be eliminated. This will be controlled by the supervision. Intervention 2: Control group: No exercise intervention will be received by the researcher; only the pre-blood donation recommendations will be received. The control group will be required to inform the researcher in case of regular exercise and use of medicinal and non-prescriptive supplements, in order to eliminate them if necessary. So high-fatty foods (especially for shimmering) will be eliminated. This will be controlled by the supervision.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nader Shakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Science and Research Branch, Hessarak blvd, University Square, Shahid Sattari Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1669445564</zip>
        <telephone>+98 21 4486 5179</telephone>
        <email>nsprofsport@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nader Shakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Science and Research Branch, Hessarak blvd, University Square, Shahid Sattari Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1669445564</zip>
        <telephone>+98 21 4486 5179</telephone>
        <email>nsprofsport@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>men shift workers aged 25 to 40 years
at least 5 years of shift work history
no smoking
lack of chronic cardiovascular disease
lack of uncontrolled blood pressure
lack of respiratory diseases
lack of severe skeletal and articular problems
lack of diabetes
lack of infectious and inflammatory diseases
lack of history of recurrent hypoglycemia or during exercise
Not having regular exercise in the last six months</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>infected with other infectious diseases</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: According to the World Health Organization's recommendation for weight adjustment and risk reduction of cardiovascular disease, physical activity with moderate intensity  is determined for intervention group. Intervention is conducted 3 days a week with  a day rest  between sessions and for 8 weeks at 17-19 pm. Each session consists of 10 minutes of warm-up (running and stretching), 30 minutes of running, and 5 to 7 minutes of cool-down (running and stretching) with the examiner's supervision. To observe the principle of over-load, the physical activity of the intervention group starts at 50% of the Target Heart Rate and will reach 70% in the final weeks. The activity is controlled by the beaconometer. So high-fatty foods (especially for shimmering) will be eliminated. This will be controlled by the supervision.</i_keyword>
      <i_keyword>Control group: No exercise intervention will be received by the researcher; only the pre-blood donation recommendations will be received. The control group will be required to inform the researcher in case of regular exercise and use of medicinal and non-prescriptive supplements, in order to eliminate them if necessary. So high-fatty foods (especially for shimmering) will be eliminated. This will be controlled by the supervision.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiac troponin I. Timepoint: Blood sampling 48 hours before the first training session (intervention) and 48 hours after the last training session (intervention). Method of measurement: French Biosynex kit by ELISA method.</prim_outcome>
      <prim_outcome>High Sensetive-C-Reactive Protein. Timepoint: Blood sampling 48 hours before the first training session (intervention) and 48 hours after the last training session (intervention). Method of measurement: England Omega Diagnostics LTD kit by ELISA method.</prim_outcome>
      <prim_outcome>Blood lipids and lipoproteins. Timepoint: Blood sampling 48 hours before the first training session (intervention) and 48 hours after the last training session (intervention). Method of measurement: by Spectophotometer device.</prim_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: 48 hours before the first training session (intervention) and 48 hours after the last training session (intervention). Method of measurement: With Digital Blood Pressure (Norditalia BP-510, Italy) from the left wrist.</prim_outcome>
      <prim_outcome>Anthropometric Indicators. Timepoint: 48 hours before the first training session (intervention) and 48 hours after the last training session (intervention). Method of measurement: height by Seca stadimeter; body weight, body mass Index, body fat percentage, and visceral by Omron impedance bio-electrical device; and The wrist hip ratio by non-elastic meter strip.</prim_outcome>
      <prim_outcome>Rest Heart Rate. Timepoint: 48 hours before the first training session (intervention) and 48 hours after the last training session (intervention). Method of measurement: With Digital Norditalia (BP-510, Italy).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-25</approval_date>
        <contact_name>Ethics committee of Islamic Azad University- Science and Research Branch</contact_name>
        <contact_address>Science and Research Branch, Hessarak Blvd, University Square, Shahid Sattari Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
