<?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>IRCT20200803048287N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-28</date_registration>
      <primary_sponsor>The organization has not supported</primary_sponsor>
      <public_title>Effect of Exercise on Heart, Blood sugar and Lipid Profile</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Aerobic Training  on Level of Serum Troponin I , CK-MB ,Glycemic  Indices and  Lipid Profile  in Type 2 Diabetes Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>18</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50082</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Groups included: Experimental or intervention group: 15 diabetic women participating in moderate-intensity aerobic exercise and control group: 15 diabetic women who did not engage in regular exercise. Interventions: The subjects in the control group did not do any exercise. In the intervention group, the exercise program included aerobic exercises that were performed for 8 weeks, 3 (sessions per week). Moderate-intensity aerobic exercise, including walking, was performed at 55 to 75 percent of maximum heart rate, Randomization description: Block randomization method is used to assign samples to each group. For this purpose, we use random allocation software and select the block alloc
ation method. The software categorizes numbers into two groups by assigning them to people. The researcher then divides the people into two groups according to the output list.Random aliocation software was used for this purpose. In the software we specify the number of blocks (2 blocks) then the software gives us a list that randomly, the samples are assigned to two groups. Samples are selected based on that, Blinding description: In this study, participants in each group did not know about other people and their treatment plan. People in each group are called in for tests on different days. Also, the clinical caregiver who is responsible for recording test results and clinical descriptions does not know which group this person belongs to. In addition, the data is entered in such a way that the treatment and control groups are marked with letters. The statistician cannot be informed about the group of people during the analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 15 diabetic women participating in moderate intensity aerobic exercise. Intervention: Exercise program including aerobic exercise that was performed for 8 weeks, 3 (sessions per week). Moderate-intensity aerobic exercise, including walking, was performed at 55 to 75 percent of maximum heart rate. These exercises were performed for 150 minutes per week and each session lasted 50 minutes. The warm-up program included 10 minutes of warm-up in the form of jogging, combined arm and leg movements, and stretching exercises. Performing aerobic exercises, the first two weeks 35 and once every two weeks, observing the principle of gradual overload, 5 minutes were added to the training time, and when returning to the initial state, 10 minutes of cooling movements were allocated. Exercises were performed in a gym at a temperature of 25 degrees Celsius. Intervention 2: Control group: 15 diabetic women who did not have any regular exercise.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Batool Amini Najafabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 22/3, Shadan dead end, Shahram alley, Amirkabir street,</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514763493</zip>
        <telephone>+98 31 4264 7809</telephone>
        <email>amini12445522@gmail.com</email>
        <affiliation>Education Najafabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Batool Amini Najafabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 22/3, Shadan dead end, Shahram alley, Amirkabir street,</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514763493</zip>
        <telephone>+98 31 4246 7809</telephone>
        <email>amini12445522@gmail.com</email>
        <affiliation>Education Najafabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being in the Age Range of 50 to 30 Years.
Diabetes was Based on the Criteria of the World Health Organization.
Having Diabetes more than Three Years.
Treatment only with Medicines Edible and non Insulin Injections
not having Sports Activity Regular Physical, at Least the Last 6 Months
Not affecting any of the diseases (including history of cardiovascular disease, history of heart surgery) on research variables
No smoking, alcohol, caffeine</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of cardiovascular disease, history of heart surgery
Have regular physical activity for at least the last 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 15 diabetic women participating in moderate intensity aerobic exercise. Intervention: Exercise program including aerobic exercise that was performed for 8 weeks, 3 (sessions per week). Moderate-intensity aerobic exercise, including walking, was performed at 55 to 75 percent of maximum heart rate. These exercises were performed for 150 minutes per week and each session lasted 50 minutes. The warm-up program included 10 minutes of warm-up in the form of jogging, combined arm and leg movements, and stretching exercises. Performing aerobic exercises, the first two weeks 35 and once every two weeks, observing the principle of gradual overload, 5 minutes were added to the training time, and when returning to the initial state, 10 minutes of cooling movements were allocated. Exercises were performed in a gym at a temperature of 25 degrees Celsius</i_keyword>
      <i_keyword>Control group: 15 diabetic women who did not have any regular exercise.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Troponin I. Timepoint: To measure troponin I in 3 times: 1- Pre-test 2- Six hours after the first exercise 3- Six hours after the last exercise session. Method of measurement: Troponin I was measured using a monobind kit and Dynex device and Eliza method. The normal range in this method is up to 0.3 ng / ml.</prim_outcome>
      <prim_outcome>Creatine Kinase MB. Timepoint: In 3 times: 1- Pre-test 2- Twelve hours after the first training session 3- Twelve hours after the last training session. Method of measurement: Immuno inhibition was performed using the Biosystem kit and the BA400 autoanalyzer. The normal range in this method is up to 24 U / L.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: After 12 hours of overnight fasting in the pre-test, and in the post-test (48 hours after the last training session). Method of measurement: Glucose Oxidase was performed using Biosystem kit and BA400 autoanalyzer.</prim_outcome>
      <prim_outcome>Glycosylated hemoglobin A1C. Timepoint: After 12 hours of overnight fasting in the pre-test, and in the post-test (48 hours after the last training session). Method of measurement: Immuno turbid metric was performed using Axzshzld kit and BA400 autoanalyzer.</prim_outcome>
      <prim_outcome>Fat profile (lipid profile). Timepoint: After 12 hours of overnight fasting in the pre-test, and in the post-test (48 hours after the last training session). Method of measurement: It was performed using the biosystem company kit and with BA400 autoanalyzer and peroxidase method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Troponin I. Timepoint: To measure troponin I in 3 times: 1- Pre-test 2- Six hours after the first exercise 3- Six hours after the last exercise session. Method of measurement: Troponin I was measured using a monobind kit and Dynex device and Eliza method. The normal range in this method is up to 0.3 ng / ml.</sec_outcome>
      <sec_outcome>Creatine Kinase MB. Timepoint: To measure CK-MB in 3 times: 1- Pre-test 2- Twelve hours after the first training session 3- Twelve hours after the last session. Method of measurement: CK-MB was measured using Biosystem kit and BA400 autoanalyzer by Immuno inhibition method. The normal range in this method is up to 24 U / L.</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>The organization has not supported</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-09</approval_date>
        <contact_name>Ethics Committee in Islamic Azad University-Najafabad Branch</contact_name>
        <contact_address>No. 3/22, Shadan dead end, Shahram alley, Amirkabir street, Najaf Abad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
