<?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>IRCT20200729048252N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-05</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of aerobic exercise on cardiac inflammatory factors in diabetic women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aerobic exercise type on cardiac inflammatory markers in women with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50037</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Thirty-six diabetic patients are randomly divided into three groups of 12 through a random number table. The first and second groups are selected as the intervention group and the third group is selected as the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group (high-intensity interval  training): consists of 10 minutes of warm-up with an intensity of 50-60% of the maximum heart rate, followed by four intense four-minute intervals with an intensity of 90% of the maximum heart rate, and after At each intense alternation, subjects take three minutes of active rest at 50-60% of their maximum heart rat.This training program is performed for 12 weeks and three sessions per week. Intervention 2: The second intervention group (  moderate intensity continuous training): consists of 10 minutes of warm-up with an intensity of 50-60% of the maximum heart rate. Subsequently, continuous training is performed for 47 minutes and with an intensity of 70-60% of the maximum heart rate. This training program is performed for 12 weeks and three sessions per week. Intervention 3: Control group: The subjects in the control group continue their usual daily program and do not participate in any regular physical training program until the end of the research.</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 after unidentifiable individuals

When:
3 months after printing the results

To whom:
All researchers

Conditions:
Participants in the study can learn about the results and documents in detail to find out how the protocols affect their disease conditions so that they can use the protocols if they are useful. Researchers can also use the results in similar studies access documents. People working in rehabilitation departments to perform registered protocols for diabetics can also from use documentation and protocol.

Where to obtain:
Send your request to the following email address .
Masoumeh.gholaman@gmail .com

How to obtain:
People requesting an email with the subject of the request to the address .They will send a form for them as soon as they receive it.Will post the profile of the people and the reason for their request in this the form will be registered after completing the form and resending the form to the item email comments on the documents will be provided as a pdf file.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Gholaman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 19, Sarv 2, Sarv St., Farsad Sharghi, Javanmardan Boulevard, Shahrziba</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1487765681</zip>
        <telephone>+98 21 4414 4738</telephone>
        <email>Masoumeh.gholaman@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Gholaman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 19, Sarv 2, Sarv St., Farsad Sharghi, Javanmardan Boulevard, Shahrziba</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1487765681</zip>
        <telephone>+98 21 4414 4738</telephone>
        <email>Masoumeh.gholaman@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women in the age range of 35 to 50 years
They develop type 2 diabetes by measuring their fasting glucose twice (mean above 125 mg / dL) and having it approved by a doctor.
Body mass index higher than 25 and less than 30 kg / m2
Lack of cardiovascular disease
Lack of regular physical exercise in the last year
No restrictions or physical problems to participate in the training program</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to sign informed written consent
Smoking and alcohol at least once a week
Pregnancy and lactation
Menopause
Hyper tention
Liver and kidney failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group (high-intensity interval  training): consists of 10 minutes of warm-up with an intensity of 50-60% of the maximum heart rate, followed by four intense four-minute intervals with an intensity of 90% of the maximum heart rate, and after At each intense alternation, subjects take three minutes of active rest at 50-60% of their maximum heart rat.This training program is performed for 12 weeks and three sessions per week.</i_keyword>
      <i_keyword>The second intervention group (  moderate intensity continuous training): consists of 10 minutes of warm-up with an intensity of 50-60% of the maximum heart rate. Subsequently, continuous training is performed for 47 minutes and with an intensity of 70-60% of the maximum heart rate. This training program is performed for 12 weeks and three sessions per week.</i_keyword>
      <i_keyword>Control group: The subjects in the control group continue their usual daily program and do not participate in any regular physical training program until the end of the research.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pentraxine 3. Timepoint: Before training protocols and 12 weeks later (after training protocols are completed). Method of measurement: Using the ELISA laboratory kit.</prim_outcome>
      <prim_outcome>Cardiotrophin 1. Timepoint: Before training protocols and 12 weeks later (after training protocols are completed. Method of measurement: Using the ELISA laboratory kit.</prim_outcome>
      <prim_outcome>Galactin 3. Timepoint: Before training protocols and 12 weeks later (after training protocols are completed. Method of measurement: Using the ELISA laboratory kit.</prim_outcome>
      <prim_outcome>Interleukin 6. Timepoint: Before training protocols and 12 weeks later (after training protocols are complet. Method of measurement: Using the ELISA laboratory kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glucose. Timepoint: Before training protocols and 12 weeks later (after training protocols are completed). Method of measurement: Pars Azmoun Company Kit.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: Before training protocols and 12 weeks later (after training protocols are completed). Method of measurement: Insulin ELISA Kit.</sec_outcome>
      <sec_outcome>Insulin resistance. Timepoint: Before training protocols and 12 weeks later (after training protocols are completed). Method of measurement: Evaluation of homeostasis model (HOMA-IR).</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>Research Assistant,  Islamic Azad University - Research Sciences Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-24</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Research Sciences Branch</contact_name>
        <contact_address>Shohada Hesarak Boulevard, University Square, Ehe end of 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>
