<?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>IRCT20150531022498N29</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-15</date_registration>
      <primary_sponsor>Rasht Branch, Islamic Azad University</primary_sponsor>
      <public_title>Effect of a period of combined exercise training in patients with diabetes type II after breast cancer surgery</public_title>
      <acronym></acronym>
      <scientific_title>Effect of a period of combined exercise training on tumor markers, blood glucose homeostasis, blood lipid, upper limb range of motion and quality of life among patients with diabetes type II after breast cancer surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32730</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Subjects were divided into 2 groups (one control group and 1 experimental groups) using the random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Eight weeks of concurrent resistance and aerobic exercises with 3 sessions per week will be done. Aerobic exercise including Ergometer, treadmills and aerobic with an intensity of 50 to 75% of maximum heart rate will be conducted. Resistance exercises are done using elastic Bands. Intervention 2: Control group:  Without any intervention, subjects in this group will continue their normal routines during the 8-week study period.</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 En The study was not completed</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam kolaei, Pouran Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht Branch, Islamic Azad University, Taleshan Bridge</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>Pouranakb@gmail.com</email>
        <affiliation>Rasht Branch, Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ramin Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>ی 4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>shabani_msn@yahoo.com</email>
        <affiliation>Azad University of Rasht Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with type 2 diabetes after breast cancer surgery
Performing Chemotherapy and Radiation Therapy
Not having exercise training</inclusion_criteria>
      <agemin>46 years</agemin>
      <agemax>67 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having any particular diet
Patients with psychiatric and nervous disorders who are being treated with sedative medicines
Patients with orthopedic, verbal and auditory problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Eight weeks of concurrent resistance and aerobic exercises with 3 sessions per week will be done. Aerobic exercise including Ergometer, treadmills and aerobic with an intensity of 50 to 75% of maximum heart rate will be conducted. Resistance exercises are done using elastic Bands.</i_keyword>
      <i_keyword>Control group:  Without any intervention, subjects in this group will continue their normal routines during the 8-week study period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>CEA Plasma level. Timepoint: Before and after the end of 8weeks of training. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>CA15-3 Plasma level. Timepoint: Before and after the end of 8weeks of training. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Before and after the end of 8weeks of training. Method of measurement: ELISA Kit and HOMA-IR index.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Shoulder pain. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: Using the MPQ Pain Questionnaire.</prim_outcome>
      <prim_outcome>Range of motion of upper limb. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: goniometer.</prim_outcome>
      <prim_outcome>Blood glucose. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Total Cholesterol. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Triglycerides. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Low density lipoprotein. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>HbA1c. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: ELISA Kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: Using the WHOQOL questionnaire.</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: Using the anxiety questionnaire.</sec_outcome>
      <sec_outcome>Physical  fitness. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: Using aerobic power measurement.</sec_outcome>
      <sec_outcome>Body composition. Timepoint: Before and after the end of 8 weeks of training. Method of measurement: Measure waist circumference , height , weight, body fat percentage, body mass index using the In body device.</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>Rasht Branch, Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-15</approval_date>
        <contact_name>Ethics committee of Rasht Azad University</contact_name>
        <contact_address>Rasht Branchو Islamic Azad University, Taleshan Bridge Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-15</approval_date>
        <contact_name>Ethics committee of Rasht Azad University</contact_name>
        <contact_address>Rasht Branch, Islamic Azad University, Taleshan Bridge Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
