<?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>IRCT20181219042055N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-17</date_registration>
      <primary_sponsor>Research and Treatment Center for Sshahid Rajaee Heart and Heart Research Center</primary_sponsor>
      <public_title>The effect of two types of aerobic exercise on inflammatory factors in diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of eight weeks of intense and continuous periodic exercises on plasma levels of myeloperoxidase in type 2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36209</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization Tool: Randomization Tool: Like a random number table, a stacked envelope, a statistical software of the lottery method was used after the sample size was determined. For each member of the community, we assigned a code or number, and it was written on cardboard and poured into a bag, and then one out of the bag, Blinding description: This study is done in trivial blinds and the only researcher knows how to assign individuals to different groups. In general, all participants in this project are unaware of what kind of sports group they have been told, and the researcher will individually give the exercises to individuals, and no explanation will be given about the type and name of the exercise. The only workout style that is aerobic and will be done on the treadmill will be notified to individuals. In data analyzers, clinical care, outcome evaluators, as well as safety committees and data monitoring, there will be no information about how to assign exercises.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: An intense periodic exercise group that performs aerobic training for 8 weeks and 3 sessions per week. Intervention 2: Intervention group: The continuous training group will conduct aerobic training sessions for 8 weeks and 3 sessions per week. Intervention 3: The control group is not given any training.</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:
In this study, the personal information of the participants in the project, such as age range, height range, weight range, BMI range, individuals will be published as a table.Also, after completing the protocol, the result of the effect of different protocols. It will also be noted on specified factors as well as factors such as insulin resistance and HA1C willalso be published.

When:
Access time since 1398

To whom:
All participants in this project can get results if they so wish. Also, all diabetics at the Shahid Rajaee Cardiology and Semnan University can access the results of this project. People working in the rehabilitation departments of Rajaee Hospital.

Conditions:
Participants in the study and diabetics at Shahid Rajaee Hospital, and in order to know how the protocols affect the conditions of their illness, they can be informed of the results and documentation so that they can be used if the protocols are useful. Also, researchers can access the documentation to use the results in similar research. People working in rehab groups can also use documentation and protocols to conduct protocols for diabetics.

Where to obtain:
Individuals can send their requests to the following email addresses:mohsenavandi@gmail.com

How to obtain:
Individuals requesting an email with an incident request will send their addresses to them. Upon receipt of the email, a form will be sent to them, specifying the individuals and the reason they will be required to register on this form after completing the form and resubmitting. The form will be submitted to the pdf file by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sara lotfiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr St., Intersection of Prayer, Research Center for Heart and Shahid Rajaee Heart Therapy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 23922489</telephone>
        <email>lotfiyan.s@iums.ac.ir</email>
        <affiliation>Research center for cardiovascular and cardiology research of Shahid Rajaee</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sohsen Avandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan - Opposite Sokan Park - Campus No. 1 - Central Organization of Semnan University</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35131-19111</zip>
        <telephone>+98 23 3365 4100</telephone>
        <email>mohsenavandi@gmail.com</email>
        <affiliation>Semnan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with type 2 diabetes
Age range 35 to 60 years
Body mass is between 25 and 35 kg / m 2</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with cardiovascular disease
People with pulmonary disease
People with pulmonary disease
smokers
Alcoholic people
People who have gout or orthopedic restrictions</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: An intense periodic exercise group that performs aerobic training for 8 weeks and 3 sessions per week.</i_keyword>
      <i_keyword>Intervention group: The continuous training group will conduct aerobic training sessions for 8 weeks and 3 sessions per week.</i_keyword>
      <i_keyword>The control group is not given any training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plasma levels of Myeloperoxidase. Timepoint: Before starting the training protocols and 8 weeks later (after completing the practice protocols). Method of measurement: blood sampling.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shahid Rajaee Cardiology Research and Treatment Center</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Semnan University</source_name>
      <source_name>Shahid Rajaee Cardiology Research and Treatment Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-29</approval_date>
        <contact_name>Ethics Committee, Educational Center, Shahid Rajaee Cardiology Research Research Center</contact_name>
        <contact_address>Valiasr Ave., Intersection of the prayer center of Shahid Rajaee Cardiology Research Center Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
