<?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>IRCT201204249555N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-08</date_registration>
      <primary_sponsor>Cardiovascular Research Center of Ahvaz Jundishapor University of Medical Sciences</primary_sponsor>
      <public_title>Exercise training in post-CABG patients</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of moderate aerobic exercise training on brachial artery flow-mediated dilatation in patients with coronary artery bypass graft surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10119</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>effects of exercise training on endothelium-dependent dilation in patients with CABG history.</hc_freetext>
      <i_freetext>of all 40 patients intending in study, 20 cases will attend supervised aerobic moderate treadmill walking  sessions(60-80% of the maximal heart rate predicted for the patient's age), three times a week. The sessions will continue for 6 weeks for each case. Before treadmill walking, 5 minutes of warm up including stretching exercises will perform for each subject. The treadmill walking starts using the Harbor treadmill protocol as follow: 3 minutes of relatively slow "warm-up" speed, followed by gradual increase in constant amount (1 to 4 percent per minute) for up to 10 minutes depending on the person’s fitness. The test will stop prior to achievement of the target heart rate if the patient develops significant chest discomfort, shortness of breath, dizziness, unsteady gait, or if the electrocardiogram shows alarming ischemic changes or serious arrhythmia's.All Patients (cases and controls) will  asked to maintain their normal diet and other lifestyle behaviors, as well as their medications. &#13;
Assessments will then repeat for all 40 subjects, and crossover will occur with final assessments made 6 weeks after entry..</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzane Ahmadi M.D.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135733118</zip>
        <telephone>+98 61 1374 3036</telephone>
        <email>ahmadithc@yahoo.com; ishbalit@yahoo.com; golestanhospital@yahoo.com</email>
        <affiliation>Cardiovascular Research Center of Ahvaz Jundishapor University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzane Ahmadi M.D.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135733118</zip>
        <telephone>+98 61 1374 3036</telephone>
        <email>ishbalit@yahoo.com; ahmadithc@yahoo.com</email>
        <affiliation>Cardiovascular Research Center of Ahvaz Jundishapor University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: post-CABG men; age 40 to 65 years;&#13;
Exclusion criteria: CABG  in last 3 months; angioplasty in last 3 months;  myocardial infarction in last 3 months;  valvular heart disease; left ventricular ejection fraction &lt; 40%; chronic obstructive pulmonary disease; chronic renal failure; liver failure; Patients who previously had moderate aerobic exercise as their routine physical activities.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z50.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cardiac Rehabilitation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>of all 40 patients intending in study, 20 cases will attend supervised aerobic moderate treadmill walking  sessions(60-80% of the maximal heart rate predicted for the patient's age), three times a week. The sessions will continue for 6 weeks for each case. Before treadmill walking, 5 minutes of warm up including stretching exercises will perform for each subject. The treadmill walking starts using the Harbor treadmill protocol as follow: 3 minutes of relatively slow "warm-up" speed, followed by gradual increase in constant amount (1 to 4 percent per minute) for up to 10 minutes depending on the person’s fitness. The test will stop prior to achievement of the target heart rate if the patient develops significant chest discomfort, shortness of breath, dizziness, unsteady gait, or if the electrocardiogram shows alarming ischemic changes or serious arrhythmia's.All Patients (cases and controls) will  asked to maintain their normal diet and other lifestyle behaviors, as well as their medications. &#13;
Assessments will then repeat for all 40 subjects, and crossover will occur with final assessments made 6 weeks after entry.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Flow mediated dilation of Brachial artery. Timepoint: before and after exercise training period. Method of measurement: Flow mediated dilation as an index of endothelium-dependent vasodilatation intended as percentage of increase in brachial artery diameter after deflating the cuff compared to its original size.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Brachial artery internal diameter. Timepoint: before and after exercise training period. Method of measurement: brachial artery internal diameter mesured by doppler sonography.</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>Cardiovascular Research Center of Ahvaz Jundishapor University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-06-15</approval_date>
        <contact_name>Ahvaz Jundishapor University of Medical Sciences</contact_name>
        <contact_address>Golestan street Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
