<?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>IRCT20220702055347N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-20</date_registration>
      <primary_sponsor>Tarbiat Modares University of Tehran</primary_sponsor>
      <public_title>The Effect of a Multi Component Exercise Program on Cognitive Function of Women with Type 2 Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of a Multi Component Exercise Program on Cognitive Function in Women with Type 2 Diabetes, with a Special Focus on Serum Levels and Geno typing of Selected cytokine TNF alpha and IL-10 Polymorphisms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64586</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: The samples will be determined by the random block method with blocks of 4 and using the random number table of the random allocation software. Blocking and allocation sequence will be done for concealment by a person not involved in the research (allocation concealment). The allocation ratio of the samples will be one to one and they will be placed in two sports intervention and control groups. Then, based on the obtained blocks and according to the allocation sequence, the multiple exercise training program will be given to the exercise intervention group. Blinding will not occur in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": A 3-month multi component exercise intervention consisting of stretching, resistance, dual task and balance exercises will be implemented. The intensity of aerobic exercises will be kept 40 to 60 maximum reserve heart rate and the number of sessions will increase from 3 to 5 per week. Intervention 2: "Control group":No intervention will be carried out in this group, and patients will continue their usual routine before the pre-test.</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:
Part of the data related to the main outcome can be shared.

When:
The access period starts 6 months after the results are published.

To whom:
People approved by the supervisor

Conditions:
For scientific purposes

Where to obtain:
Supervisor

How to obtain:
E-mail correspondence with the supervisor
molanouri@modares.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Mahdieh Molanouri Shamsi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasr Bridge,Jalal Al Ahmad St,Tehran,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4683</telephone>
        <email>molanouri@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdie Molanori Shamsi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasr Bridge,Jalal Al Ahmad St,Tehran,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 0000</telephone>
        <email>molanouri@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fasting blood glucose more than 7 mmol/L
Hemoglobin A1c more than 6.5
Do not have cognitive function, heart and joint problems
People with type 2 diabetes
Be in the desired age range</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus without complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": A 3-month multi component exercise intervention consisting of stretching, resistance, dual task and balance exercises will be implemented. The intensity of aerobic exercises will be kept 40 to 60 maximum reserve heart rate and the number of sessions will increase from 3 to 5 per week.</i_keyword>
      <i_keyword>"Control group":No intervention will be carried out in this group, and patients will continue their usual routine before the pre-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Interleukin 10 genotyping. Timepoint: Before and after 3 months interventions. Method of measurement: Restriction fragment length polymorphism.</prim_outcome>
      <prim_outcome>Tumour necrosis factor α genotyping. Timepoint: Before and after 3 months interventions. Method of measurement: Restriction fragment length polymorphism.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Tumor necrosis factor alpha cytokine. Timepoint: Before and after 3 months intervention. Method of measurement: Enzyme-linked immunosorbent assay.</sec_outcome>
      <sec_outcome>Interleukin 10 cytokine. Timepoint: Before and after 3 months intervention. Method of measurement: Enzyme-linked immunosorbent assay.</sec_outcome>
      <sec_outcome>Executive function. Timepoint: Before and after 3 months intervention. Method of measurement: Trail Making Test.</sec_outcome>
      <sec_outcome>Respiratory and cardiovascular system, blood circulation and muscle. Timepoint: Before and after 3 months intervention. Method of measurement: 6-Minute Walk Test.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before and after 3 months intervention. Method of measurement: Weight in kilograms divided by the square of height in meters.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Cognitive Sciences and Technology Council</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tarbiat Modares University of Tehran</source_name>
      <source_name>Cognitive Sciences and Technology Council</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-22</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modares University</contact_name>
        <contact_address>Jalal Al Ahmad St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
