<?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>IRCT20190917044797N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-05</date_registration>
      <primary_sponsor>The University of tabriz</primary_sponsor>
      <public_title>The effect of  high-intensity interval training (HIIT)  and  vitamin D supplementation on older men</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 8 weeks of high-intensity interval training (HIIT) with and without vitamin D supplementation on some muscle atrophy indexes in older men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61494</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: At first, the subjects will be selected using a simple random method. Then, using a table of random numbers, they are divided into four groups: control, exercise, vitamin D and exercise + vitamin D. Therefore, each candidate will be assigned a two-digit number from 01.02.000 to 40. Starting from a point on the table of random numbers in the direction of the desired row or column, the same number of digits is determined for the selection of individuals (five-digit numbers whose last two digits are similar to the existing codes) that are randomly assigned to one of the groups It will be given. This will continue until the number of people in each group is completed. Therefore, the researcher will not have the option to change the status of the assignment or predict it. Random hiding will be done by a third party who does not participate in other stages of the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sarcopenia.</hc_freetext>
      <i_freetext>Intervention 1: Control group: without receiving supplements and exercise program. Intervention 2: Intervention group: The daily intake of 2000 international units of vitamin D per day will be done for eight weeks. Intervention 3: Intervention group: Group three (high-intensity interval training ): Subjects in the high-intensity interval training group will participate 3 days a week for 8 weeks of high-intensity interval training with an intensity of more than 75% of the reserve heart rate. Blood samples are taken at rest 48 hours before the start of training and 48 hours after the last training session. Intervention 4: Intervention group: Group four (High-intensity interval training  +Vitamin D group): Subjects in the high-intensity interval training group will take vitamin D, 3 days a week, for 8 weeks of high-intensity interval training with an intensity of more than 75% of the reserve heart rate. During this period, 2,000 international units of vitamin D will be consumed every day. Blood samples are taken at rest 48 hours before the start of training and 48 hours after the last training session.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kaveh Baturak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>29 Bahman Blvd., University of Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3334 0081</telephone>
        <email>Kawa.Baturak@gmail.com</email>
        <affiliation>The University of tabriz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javad Vakili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>29 Bahman Blvd., University of Tabriz, Faculty of Physical Education and Sport Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3339 3257</telephone>
        <email>Vakili@tabrizu.ac.ir</email>
        <affiliation>The University of tabriz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 60 to 75 years
inactive (less than 90 minutes of regular exercise per week)
Do not use drugs and anabolic supplements, blood pressure, anti-inflammatory and antioxidants</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>The elderly are injured
Metabolic and cardiovascular diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Muscle wasting and atrophy, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: without receiving supplements and exercise program</i_keyword>
      <i_keyword>Intervention group: The daily intake of 2000 international units of vitamin D per day will be done for eight weeks.</i_keyword>
      <i_keyword>Intervention group: Group three (high-intensity interval training ): Subjects in the high-intensity interval training group will participate 3 days a week for 8 weeks of high-intensity interval training with an intensity of more than 75% of the reserve heart rate. Blood samples are taken at rest 48 hours before the start of training and 48 hours after the last training session.</i_keyword>
      <i_keyword>Intervention group: Group four (High-intensity interval training  +Vitamin D group): Subjects in the high-intensity interval training group will take vitamin D, 3 days a week, for 8 weeks of high-intensity interval training with an intensity of more than 75% of the reserve heart rate. During this period, 2,000 international units of vitamin D will be consumed every day. Blood samples are taken at rest 48 hours before the start of training and 48 hours after the last training session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of vitamin D. Timepoint: 48 hours before and after 8 weeks of exercise training. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Serum levels of Insulin-like hormone 1. Timepoint: 48 hours before and after 8 weeks of exercise training. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>Serum levels of myostatin hormone. Timepoint: 48 hours before and after 8 weeks of exercise training. Method of measurement: Using the ELISA method.</prim_outcome>
      <prim_outcome>MiRNA-1. Timepoint: 48 hours before and after 8 weeks of exercise training. Method of measurement: Real Time PCR technique.</prim_outcome>
      <prim_outcome>MiRNA-133a. Timepoint: 48 hours before and after 8 weeks of exercise training. Method of measurement: Real Time PCR technique.</prim_outcome>
      <prim_outcome>MiRNA-206. Timepoint: 48 hours before and after 8 weeks of exercise training. Method of measurement: Real Time PCR technique.</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>The University of tabriz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-02</approval_date>
        <contact_name>Ethics committee of tabriz University</contact_name>
        <contact_address>29 Bahman Blvd., University of Tabriz tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
