<?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>IRCT20210426051087N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-11</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of combined rehabilitation exercises in patients with coronary artery bypass grafting</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a combined training session on ABCA5 and ApoB gene expression and white blood cell lipid profile in middle-aged men after cardiac bypass surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55845</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In fact, this study was performed to investigate the effect of endurance and resistance training on the physiological status of patients with coronary artery bypass grafting, Randomization description: The samples will be determined by random blocking method with 4 blocks using the table of random numbers of Software Allocation Random software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic ischaemic heart disease, unspecified.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Aerobic-resistance training group. After taking blood samples and functional tests (5-second unassisted sit-up test (TUG), 3-meter back and forth (BBS) and cardiorespiratory function (6-minute walk)), participants are asked Start the training session with an aerobic program in three parts: walking on a treadmill (20 to 30 minutes), cycling (10 to 12 minutes) and manual ergometer (10 minutes) with an intensity of 60% of maximum heart rate. Then, by performing a resistance training program in three consecutive sets with 8 to 15 repetitions, the training session ends. The intensity of resistance training can be changed by using different colors (yellow to pink) of Traband. Then, at the end of the training period, blood is taken again and the functional test is measured again. Intervention 2: Intervention group: Resistance-aerobic training group. After taking blood samples and functional tests (5-second unassisted sit-up test (TUG), 3-meter back and forth (BBS) and cardiorespiratory function (6-minute walk)) from participants Is asked to Perform resistance training program in three consecutive sets with 8 to 15 repetitions. The intensity of resistance training can be changed by using different colors (yellow to pink) of Traband. Then the training session is completed with an aerobic program in three parts that included walking on a treadmill (20 to 30 minutes), pedaling on a bicycle (10 to 12 minutes) and hand ergometer (10 minutes) with an intensity of 60% of maximum heart rate. Also, at the end of the training period, blood is taken again and the functional test is measured again. Intervention 3: Control group: did not have any sports activities and supplementation and illegal drugs during the research protocol.</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 We apologize for publishing the data because of the ethical commitment it has made to patients and the Patient Rehabilitation Center.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Amir Rashid Lamir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vakil Abad Ave. Park Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9173613111</zip>
        <telephone>+98 51 3880 3000</telephone>
        <email>m_akbari64@hotmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No38. Vakil Abad Ave. Hashemiyeh Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>917861311</zip>
        <telephone>+98 51 3880 3000</telephone>
        <email>m_akbary64@hotmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 50-60 years
Willingness to participate in research
Cognitive, visual and auditory health
No systolic blood pressure higher than 160 mmHg and diastolic blood pressure higher than 100 mmHg
No acute and advanced diseases that prevent the exercises considered in this study.</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Existence of symptoms and heart failure
Taking over-the-counter medications
Inability to perform sports activities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Aerobic-resistance training group. After taking blood samples and functional tests (5-second unassisted sit-up test (TUG), 3-meter back and forth (BBS) and cardiorespiratory function (6-minute walk)), participants are asked Start the training session with an aerobic program in three parts: walking on a treadmill (20 to 30 minutes), cycling (10 to 12 minutes) and manual ergometer (10 minutes) with an intensity of 60% of maximum heart rate. Then, by performing a resistance training program in three consecutive sets with 8 to 15 repetitions, the training session ends. The intensity of resistance training can be changed by using different colors (yellow to pink) of Traband. Then, at the end of the training period, blood is taken again and the functional test is measured again.</i_keyword>
      <i_keyword>Intervention group: Resistance-aerobic training group. After taking blood samples and functional tests (5-second unassisted sit-up test (TUG), 3-meter back and forth (BBS) and cardiorespiratory function (6-minute walk)) from participants Is asked to Perform resistance training program in three consecutive sets with 8 to 15 repetitions. The intensity of resistance training can be changed by using different colors (yellow to pink) of Traband. Then the training session is completed with an aerobic program in three parts that included walking on a treadmill (20 to 30 minutes), pedaling on a bicycle (10 to 12 minutes) and hand ergometer (10 minutes) with an intensity of 60% of maximum heart rate. Also, at the end of the training period, blood is taken again and the functional test is measured again.</i_keyword>
      <i_keyword>Control group: did not have any sports activities and supplementation and illegal drugs during the research protocol</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ABCG5 gene expression. Timepoint: 24 hours before the start of the protocol and 48 hours after the end of the last training protocol session. Method of measurement: REAL TIME-PCR method.</prim_outcome>
      <prim_outcome>APOB plasma levels. Timepoint: 24 hours before the start of the protocol and 48 hours after the end of the last training protocol session. Method of measurement: ELISA laboratory method.</prim_outcome>
      <prim_outcome>LDL plasma levels. Timepoint: 24 hours before the start of the protocol and 48 hours after the end of the last training protocol session. Method of measurement: ELISA laboratory 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-24</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Neyshabour Branch</contact_name>
        <contact_address>RESEARCH Ave, Islamic Azad University Complex Neyshabur Branch neyshabur Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
