<?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>IRCT20120129008863N20</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-11-01</date_registration>
      <primary_sponsor>Islamic Azad University, Ayatollah Amoli Branch</primary_sponsor>
      <public_title>The effect of exercise training on the profile of myokines and muscle proteins</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of 12 weeks of aerobic exercise, Tabata, and high-intensity interval training on adipo-myokine levels in obese men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93386</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Participants will be randomly assigned to four study groups in a 1:1:1:1 allocation ratio. Initially, eligible participants will be stratified based on two variables: age and body mass index (BMI). Predetermined categories will be created for each variable, and randomization will be performed independently within each stratum to ensure balance across age and BMI levels. Subsequently, block randomization with block sizes of 4 and 8 and an allocation ratio of 1:1:1:1 will be executed within each stratum. For this purpose, all possible balanced combinations of group assignments for block sizes of 4 and 8 will first be defined. Then, in SPSS software (version 26), using Syntax and the uniform random number generator command RV.UNIFORM (0,1), a random number between 0 and 1 will be generated for each block combination. The block combinations will be sorted in ascending order based on these random numbers, and the final group assignment sequence will be extracted from this ordering. To prevent sequence predictability, block sizes of 4 and 8 will be varied systematically/alternately. The final random allocation sequence will be generated by a biostatistician who is not involved in participant screening, enrollment, or evaluation, and will be stored as a coded allocation list. Group allocation will be concealed using sequentially numbered, opaque, sealed envelopes to ensure the allocation sequence remains hidden from both researchers and participants until the point of assignment. Consequently, the person assigning participants will open the corresponding envelope and reveal the allocated group only after the participant's baseline information has been fully recorded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight and obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Tabata training group will consist of 12 weeks of training (three sessions per week), with each session lasting 60 minutes and comprising 10 minutes of warm-up, 40 minutes of main training, and 10 minutes of cool-down. The main exercises for this group will be executed in eight 4-minute sets, featuring 20 seconds of very high-intensity activity (85 to 95 percent of maximum heart rate) followed by 10 seconds of rest at an intensity of 45 to 55 percent of maximum heart rate. Intervention 2: Intervention group: The High-Intensity Interval Training (HIIT) group will also perform 12 weeks of training (three sessions per week), with a similar duration of 60 minutes per session (10 minutes of warm-up, 40 minutes of main training, and 10 minutes of cool-down). The main exercises for this group will have a structure similar to the Tabata protocol, consisting of eight 4-minute sets featuring 20 seconds of high-intensity activity (85 to 95 percent of maximum heart rate) and 10 seconds of rest (45 to 55 percent of maximum heart rate). Intervention 3: Intervention group: The continuous aerobic training (ET) group will consist of 12 weeks of training (three sessions per week), with a total duration of 60 minutes per session (including 10 minutes of warm-up, 40 minutes of main training, and 10 minutes of cool-down). The intensity of the main exercises for this group will be continuously set at 65 to 75 percent of the maximum heart rate. Intervention 4: Control group: The control group will not receive any exercise or training intervention during the 12-week period and will only participate in the pre-test and post-test assessments and measurements to serve as a baseline for comparison with the intervention groups.</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, including the IPD, study protocol, statistical analysis map, informed consent form, clinical study report, and data dictionary, will be published upon completion of the study. This data will be made available in a valid journal article format.

When:
Data will be accessible immediately upon project completion, likely in 1405

To whom:
This is intended for researchers at academic and scientific

Conditions:
Institutions to support the development of related sciences.

Where to obtain:
Refer to Islamic Azad University

How to obtain:
Please submit a valid letter from the scientific centers.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asieh Abbassi Daloii</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Ayatollah Amoli Branch, Km 5, Old Amol Road</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>678</zip>
        <telephone>+011-43217126</telephone>
        <email>Abbassi.daloii@gmail.com</email>
        <affiliation>Islamic Azad University-Ayatollah Amoli Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Asieh Abbassi Daloii</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Ayatollah Amoli Branch, Km 5, Old Amol Road</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>678</zip>
        <telephone>+98 11 4321 7126</telephone>
        <email>Abbassi.daloii@gmail.com</email>
        <affiliation>Islamic Azad University-Ayatollah Amoli Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inactive male, aged 21 to 35
In good general physical and mental health
Body mass index greater than 30 kg/m²</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Any physical injury or orthopedic issue that interferes with training can hinder its quality</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</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>Intervention group: The Tabata training group will consist of 12 weeks of training (three sessions per week), with each session lasting 60 minutes and comprising 10 minutes of warm-up, 40 minutes of main training, and 10 minutes of cool-down. The main exercises for this group will be executed in eight 4-minute sets, featuring 20 seconds of very high-intensity activity (85 to 95 percent of maximum heart rate) followed by 10 seconds of rest at an intensity of 45 to 55 percent of maximum heart rate.</i_keyword>
      <i_keyword>Intervention group: The High-Intensity Interval Training (HIIT) group will also perform 12 weeks of training (three sessions per week), with a similar duration of 60 minutes per session (10 minutes of warm-up, 40 minutes of main training, and 10 minutes of cool-down). The main exercises for this group will have a structure similar to the Tabata protocol, consisting of eight 4-minute sets featuring 20 seconds of high-intensity activity (85 to 95 percent of maximum heart rate) and 10 seconds of rest (45 to 55 percent of maximum heart rate).</i_keyword>
      <i_keyword>Intervention group: The continuous aerobic training (ET) group will consist of 12 weeks of training (three sessions per week), with a total duration of 60 minutes per session (including 10 minutes of warm-up, 40 minutes of main training, and 10 minutes of cool-down). The intensity of the main exercises for this group will be continuously set at 65 to 75 percent of the maximum heart rate.</i_keyword>
      <i_keyword>Control group: The control group will not receive any exercise or training intervention during the 12-week period and will only participate in the pre-test and post-test assessments and measurements to serve as a baseline for comparison with the intervention groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dermatopontin. Timepoint: Before the intervention and three months following it. Method of measurement: Cusabio kit (ng/ml).</prim_outcome>
      <prim_outcome>Decorin. Timepoint: Before the intervention and three months following it. Method of measurement: zellBio kit (pg/ml).</prim_outcome>
      <prim_outcome>Follistatin. Timepoint: Before the intervention and three months following it. Method of measurement: zellBio kit (pg/ml).</prim_outcome>
      <prim_outcome>Myostatin. Timepoint: Before the intervention and three months following it. Method of measurement: zellBio kit (pg/ml).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index (BMI) Kg/m2. Timepoint: Before the intervention and three months following it. Method of measurement: The body mass (kg) divided by the square of the body height (cm).</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, Ayatollah Amoli Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-03</approval_date>
        <contact_name>Islamic Azad University-Ayatollah Amoli Branch</contact_name>
        <contact_address>Islamic Azad University, Ayatollah Amoli Branch, Km 5, Old Amol Road Amol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
