<?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>IRCT20201117049424N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-09</date_registration>
      <primary_sponsor>Iranian academic center for education culture and research</primary_sponsor>
      <public_title>We perform combined exercises that include aerobic and resistance training on subjects who are middle-aged men who have undergone cardiac bypass surgery. We examined its effects on ABCB4 gene expression, APOA levels and reverse cholesterol transfer.</public_title>
      <acronym>CABG</acronym>
      <scientific_title>The effect of a combined training course on lipid profile; APOA levels and expression of ABCB4 white blood cell gene in middle-aged men after cardiovascular bypass surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52511</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 will be performed on patients with coronary artery bypass grafting and will examine the effect of rehabilitation exercises on patients with coronary artery bypass grafting.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Cardiovascular disease. Condition 2: Coronary artery diseaseI70-I79. Condition 3: Circulatory system diseaseI95-I99.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": 8 weeks of cardiac rehabilitation (aerobic training and resistance training) including 3 sessions per week with an intensity of 50-80% of the reserve heart rate or Burg criterion the 13-11 depending on the strength  of the tests and for each session up to 90 minutes as follows: "Intervention group 1:; 2,Walking on a treadmill for 20 to 30 minutes ",;;" Intervention group: 1:; 3, pedaling on a stationary bike 12-10 minutes ";: Intervention group: 1:; 4, using manual ergometer  is 10 minutes and resistance training includes:" Intervention group 1:5; There are three movements for the upper limb and two movements for the lower limb. Intervention 2: Control group: Control group: No exercise was given to the control group.</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 lack of approval to provide data, I am not able to provide data and information to other centers other than Neyshabour Azad University.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Rashid lamir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hashemiye14</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91786131119</zip>
        <telephone>+98 51 3380 6000</telephone>
        <email>Rashidlamir@um.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Rashidlamir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hashemiye14</address>
        <city>Masshad</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>Systolic blood pressure greater than 160 mmHg and diastolic blood pressure higher than 100 mmHg.
Cognitive, visual and auditory health
Use walking aids such as canes and walkers.
eir operating capacity should not be less than five meters.  Hermet expresses consumption of 3.5 ml of oxygen per kilogram of body weight per minute, which was estimated based on the modified Bruce test (Fallahi Vagini 2012).
Use of neuroleptics.
Age range 50 to 60 years
At least two months have passed since their operation</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unstable angina
Uncompensated heart failure
Myocardial infarction over the past four weeks
Ventricular arrhythmia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>I60-I69بیماریهای قلبی وعروقی</hc_keyword>
      <hc_keyword>I70-I79بیمارشریان کرونری</hc_keyword>
      <hc_keyword>اختلالات نامشخص سیستم گردش خونI95-I99</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": 8 weeks of cardiac rehabilitation (aerobic training and resistance training) including 3 sessions per week with an intensity of 50-80% of the reserve heart rate or Burg criterion the 13-11 depending on the strength  of the tests and for each session up to 90 minutes as follows: "Intervention group 1:; 2,Walking on a treadmill for 20 to 30 minutes ",;;" Intervention group: 1:; 3, pedaling on a stationary bike 12-10 minutes ";: Intervention group: 1:; 4, using manual ergometer  is 10 minutes and resistance training includes:" Intervention group 1:5; There are three movements for the upper limb and two movements for the lower limb.</i_keyword>
      <i_keyword>Control group: Control group: No exercise was given to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ABCB4 gene expression. Timepoint: 24 hours before the start of the protocol and 48 hours after the last training session. Method of measurement: ABCB4 gene expression and ELISA method.</prim_outcome>
      <prim_outcome>APOA plasma levels,. Timepoint: 24 hours before the start of the protocol. Method of measurement: Gene expression and ELISA method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Neishabour Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-23</approval_date>
        <contact_name>Islamic Azad University of Neyshabour</contact_name>
        <contact_address>Neishabour Islamic Azad University Neyshabour Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
