<?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>IRCT20201115049393N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-30</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of  combined training on ABCG4 gene expression and interleukin 4 and interleukin 10 factors in middle-aged men's blood mononuclear cells after coronary artery bypass graft</public_title>
      <acronym>CABG</acronym>
      <scientific_title>The effect of  combined training on ABCG4 gene expression and interleukin 4 and interleukin 10 factors in middle-aged men's blood mononuclear cells after coronary artery bypass graft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52437</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This project is part of a doctoral thesis that has been performed on patients with coronary artery bypass grafting and examines the effect of combined rehabilitation exercises on patients with coronary artery bypass grafting.</study_design>
      <phase>3</phase>
      <hc_freetext>Patients with coronary artery bypass grafting.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Intervention group: 8 weeks of cardiac rehabilitation (aerobic training and resistance training) including 3 sessions per week with an intensity of 80-50% of the reserve heart rate or Borg standard 11-11 depending on the ability of the subjects and for each session up to 90 minutes The following: Walking on a treadmill for 20 to 30 minutes, cycling on a stationary bike for 10 to 12 minutes, using a manual ergo meter for 10 minutes, and resistance training include three repetitive sets, three movements for the upper limbs, and two lower limbs. The training course along with the usual treatment of risk factors for heart disease will include hyperglycemia and inflammation. Exercises will be performed in accordance with the principle of overload. Intervention 2: Control group: During this period, this group did not have any sports activities.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the hospital's refusal to provide data, I am not able to provide data and information to other centers other than Neishabour Azad University.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Amir Rashid Lamir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hashemieh 14. Hashemieh  Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178613111</zip>
        <telephone>+98 51 3880 4840</telephone>
        <email>amir.rashidlamir@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Amir Rashid Lamir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vakilabad Street, Ferdowsi University of Mashhad, Faculty of Sports Sciences</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178613111</zip>
        <telephone>+98 51 3880 6000</telephone>
        <email>amir.rashidlamir@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. No systolic blood pressure higher than 160 mm Hg and diastolic blood pressure higher than 100 mm Hg 2. Cognitive, visual and auditory health 3. Do not use neuroleptics 4. Do not use walking aids such as canes and walkers 5. At least 2 months have passed since their operation 6. Their functional capacity should not be less than five met. Each met represents a consumption of 3.5 ml of oxygen per kilogram of body weight per minute, which was estimated based on a modified Bruce test 7. Age range 50 to 65 years</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unstable angina, irreversible heart failure, myocardial infarction over the past four weeks, ventricular arrhythmias.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Intervention group: 8 weeks of cardiac rehabilitation (aerobic training and resistance training) including 3 sessions per week with an intensity of 80-50% of the reserve heart rate or Borg standard 11-11 depending on the ability of the subjects and for each session up to 90 minutes The following: Walking on a treadmill for 20 to 30 minutes, cycling on a stationary bike for 10 to 12 minutes, using a manual ergo meter for 10 minutes, and resistance training include three repetitive sets, three movements for the upper limbs, and two lower limbs. The training course along with the usual treatment of risk factors for heart disease will include hyperglycemia and inflammation. Exercises will be performed in accordance with the principle of overload.</i_keyword>
      <i_keyword>Control group: During this period, this group did not have any sports activities</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ABCG4 gene expression and plasma levels of interleukin 4 and interleukin 10. Timepoint: 24 hours before the start of the protocol and 48 hours after the last training session. Method of measurement: Real-time-PCT gene expression and ELISA method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>ABCG4 gene expression of interleukin 4 and interleukin 10. Timepoint: 24 hours before and 24 hours after the first and last training session. Method of measurement: Real-time-PCR method and ELISA method.</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 Branch of neyshabour Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-23</approval_date>
        <contact_name>National Committee of Ethics in Biomedical Research, Islamic Azad University. neyshabour unit</contact_name>
        <contact_address>Research Blvd., Islamic Azad University Complex, Neyshabur Branch Khorasan Razavi Province, Neyshabur Neyshabur Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
