<?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>IRCT20151026024717N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-10</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of three training interventions in obese men</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of three training interventions (aerobic interval, resistance and combination) on serum FAM19A5, arterial stiffness, glucose homeostasis and lipid and body composition indices in obese men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61060</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this research, subjects are selected simple randomization by random allocation rule. After determining the sample size, they will be equally divided into four groups (1- control, 2- aerobic interval training, 3- resistance training, 4- combined training). 
Using the lottery method, the names of the subjects are written on separate papers and placed in a container, then the names of the subjects are randomly taken out and placed in groups, respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Aerobic interval training program including 10 minutes of warm-up with 40% of maximum heart rate (HRmax) and 40 minutes of cycling including eight cycles, each of which is 3 minutes with 80% of maximum heart rate (high intensity) and 2 minutes It will run at 50% of maximum heart rate (low intensity cycle) and 10 minutes of cooling with 40% of maximum heart rate. Intervention 2: Intervention group: The resistance training program will include squats, chest presses, front thighs, back thighs, overhead wires, boat wires, forearms and back arms. During the first week, subjects perform 2 sets of 12-15 repetitions with an intensity of 40% 1RM. In the second week, the program includes 3 sets of 15-12 repetitions with an intensity of 50% 1RM. Between 3-5 weeks with the same number of sets, the number of repetitions will decrease to 8-12 and the intensity will increase to 55-60% of 1RM. From the sixth to the twelfth week, the number of repetitions of 8-12 is maintained. On the other hand, the intensity of training will increase to 80-65% of 1RM. Intervention 3: Intervention group: The combined training program is such that the subjects of this group perform one session of aerobic periodic training (according to the program of aerobic periodic group), and the next session performs resistance training (according to the program of the resistance group) and This process will continue until the end of the 12-week program for this group. Intervention 4: Control group: community-based and untrained.</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 whole data is potentially shared after unidentified individuals.

When:
The beginning of the data access period is 6 months after the publication of the articles.

To whom:
The data will be accessible only to researchers working in academic institutions.

Conditions:
The data will be available as generally and non publication by the recipient.

Where to obtain:
To receive research information, send an email to Ehsanmir1990@gmail.com

How to obtain:
Data will be sent after obtaining permission from the project manager.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behzad Bazgir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, MollaSadra street , Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8248 3131</telephone>
        <email>Ehsanmir1990@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behzad Bazgir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, MollaSadra street , Vanak Square , Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8248 3131</telephone>
        <email>Ehsanmir1990@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of the health of the subjects,
Body mass index between 30 and 35,
Age 40 to 50 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>having cardiovascular diseases,
musculoskeletal disorders,
liver diseases,
kidney diseases,
thyroid dysfunction,
having regular physical activity in at least the last six months</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Aerobic interval training program including 10 minutes of warm-up with 40% of maximum heart rate (HRmax) and 40 minutes of cycling including eight cycles, each of which is 3 minutes with 80% of maximum heart rate (high intensity) and 2 minutes It will run at 50% of maximum heart rate (low intensity cycle) and 10 minutes of cooling with 40% of maximum heart rate.</i_keyword>
      <i_keyword>Intervention group: The resistance training program will include squats, chest presses, front thighs, back thighs, overhead wires, boat wires, forearms and back arms. During the first week, subjects perform 2 sets of 12-15 repetitions with an intensity of 40% 1RM. In the second week, the program includes 3 sets of 15-12 repetitions with an intensity of 50% 1RM. Between 3-5 weeks with the same number of sets, the number of repetitions will decrease to 8-12 and the intensity will increase to 55-60% of 1RM. From the sixth to the twelfth week, the number of repetitions of 8-12 is maintained. On the other hand, the intensity of training will increase to 80-65% of 1RM.</i_keyword>
      <i_keyword>Intervention group: The combined training program is such that the subjects of this group perform one session of aerobic periodic training (according to the program of aerobic periodic group), and the next session performs resistance training (according to the program of the resistance group) and This process will continue until the end of the 12-week program for this group.</i_keyword>
      <i_keyword>Control group: community-based and untrained.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FAM19A5. Timepoint: Before the intervention and 48 hours after the end of intervention. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Arterial stiffness. Timepoint: Before the intervention and 48 hours after the end of intervention. Method of measurement: Through the pulse pressure formula.</prim_outcome>
      <prim_outcome>Lipid indices. Timepoint: Before the intervention and 48 hours after the end of intervention. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Body composition. Timepoint: Before the intervention and 48 hours after the end of intervention. Method of measurement: Body Composition Analyzer.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-18</approval_date>
        <contact_name>Baqiyatallah Al-Azam Educational and Medical Center</contact_name>
        <contact_address>Baqiyatallah Al-Azam Hospital, Mulla Sadra Street, Vanak Square, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
