<?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>IRCT2015092224146N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-10-20</date_registration>
      <primary_sponsor>Vice Chancellor for research of Ahwaz Jondi Shapoor University of Medical Sciences</primary_sponsor>
      <public_title>Effect of cardiac rehabilitation on endothelial function in smoker patients with athero sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Effect of cardiac rehabilitation on endothelial function in smoker patients with ischemic heart disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>53</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20441</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ischemic heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Control group:&#13;
  The control group did not rehabilitation. All tests are intended for groups such as blood sugar, lipid profile, renal function and pressure ratio of ankle to brachial at baseline and then measured after two months . Intervention 2: Intervention Groups:&#13;
Rehabilitation that patients exercise protocol consists of a one-hour period early on soft, about 10 minutes, and then a treadmill or stationary bike for forty minutes and finally for 10 minutes is the final exercise 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Jafarpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital,Azadegan Street,, Ahwaz</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>+98 61 3221 6504</telephone>
        <email>himam@ajums.ac.ir</email>
        <affiliation>Department of Cardiology, Ahwaz Jundi Shapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Reza Assareh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital, Azadegan Street,</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>+98 61 3221 6504</telephone>
        <email>himam@ajums.ac.ir ;assareh@yahoo.com</email>
        <affiliation>Department of Cardiology, Ahwaz Jundi Shapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Patients with a history of ischemic heart disease who currently smoke or have quit less than 5 years.&#13;
Exclusion criteria:&#13;
Patients with Diabetes (type 1,2)&#13;
The reluctance of patients to participate in the study and not personal consent by the patient.&#13;
Re infarction during the study.&#13;
Cardiovascular disorders and complications that require close care specialist such as severe ventricular arrhythmias and other serious complications.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>120-125</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischaemic heart diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group:&#13;
  The control group did not rehabilitation. All tests are intended for groups such as blood sugar, lipid profile, renal function and pressure ratio of ankle to brachial at baseline and then measured after two months .</i_keyword>
      <i_keyword>Intervention Groups:&#13;
Rehabilitation that patients exercise protocol consists of a one-hour period early on soft, about 10 minutes, and then a treadmill or stationary bike for forty minutes and finally for 10 minutes is the final exercise period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of ankle-brachial pressure. Timepoint: Before the start of rehabilitation and completion after 24 sessions. Method of measurement: Ankle blood pressure devided by brachial blood pressure by manometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The effect of rehabilitation on MET'S (metabolic equivalents [of oxygen consumption]). Timepoint: Before the start of rehabilitation and after 24 sessions. Method of measurement: By questionnaire Duke Activity Status Index.</sec_outcome>
      <sec_outcome>The effect of rehabilitation on blood suger. Timepoint: Before the start of rehabilitation and after 24 sessions. Method of measurement: By measuring fasting blood glucos.</sec_outcome>
      <sec_outcome>The effect of rehabilitation on renal function. Timepoint: Before the start of rehabilitation and after 24 sessions. Method of measurement: By measuring of GFR.</sec_outcome>
      <sec_outcome>The effect of rehabilitation on blood pressure. Timepoint: Before the start of rehabilitation and after 24 sessions. Method of measurement: Blood pressure measurement by manometer.</sec_outcome>
      <sec_outcome>The effect of rehabilitation on body mass index. Timepoint: Before the start of rehabilitation and after 24 sessions. Method of measurement: Through height and weight (the weight in kilograms by height in meters squared).</sec_outcome>
      <sec_outcome>The effect of rehabilitation on lipid profile. Timepoint: Before the start of rehabilitation and after 24 sessions. Method of measurement: By measuring triglyceride, cholesterol, HDL, LDL.</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>Vice Chancellor for research of Ahwaz Jondi Shapoor University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-23</approval_date>
        <contact_name>Ethics Committee of the University of Medical Sciences Jundi Shapur Ahwaz</contact_name>
        <contact_address>Golestan Blvd., University Town, near the center of Ahwaz Jundi Shapur University of Medical Sciences and Health Services, Department of Research and Technology, PO Box 45. Ahwaz Ahwaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
