<?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>IRCT2017013132290N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-25</date_registration>
      <primary_sponsor>Vice Chancellor of research,Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Cardiac Rehabilitation In Coronary Artery Bypass Grafting (CABG) Patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Hospital-Based Rehabilitation Versus Home-Based Exercise Training in Patients After Coronary Artery Bypass Grafting(CABG): Effects on Functional Capacity, Quality of Life, Psychological Symptoms, and Hemodynamic Parameters</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>93</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25190</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patient with Coronary Artery Bypass Grafting Surgery.</hc_freetext>
      <i_freetext>Intervention 1: Second group will receive rehabilitation at home, take exercise program after being discharged from hospital, advised to exercise orderly and call doctor when having a problem. In order to motivate this group they will receive periodic telephone calls.&#13;
A pedometer device will give them to measure the amount of their activity objectively. An educated nurse will call them weekly and ask them about calorie intake and walking distance which measured by pedometer. Intervention 2: The study included two intervention groups and one control group. The first intervention group received hospital-based usual rehabilitation program from rehabilitation center of Tehran Heart Center. Intervention 3: The control group with the same schedule as group 2 will be followed up by phone. For Ethical principles, we will advise control group to received rehabilitation program from rehabilitation center of Tehran Heart Center or having regular physical activity at homes.</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>Negar Omidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor 2, Research Center Building,Tehran Heart Center, North Kargar "St"</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8802 9600</telephone>
        <email>negar.omidi@gmail.com</email>
        <affiliation>Tehran Heart Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negar Omidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor 2, Research Center Building,Tehran Heart Center,North karegar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 225 6314</telephone>
        <email>negar.omidi@gmail.com</email>
        <affiliation>Tehran Heart Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>“Inclusion criteria”:&#13;
•	stroke volume more than 40%&#13;
•	Coronary artery bypasses surgery recently in previous 4 to 8 weeks&#13;
•	Having a normal response to exercise test&#13;
“Exclusion criteria”:&#13;
•	ventricular arrhythmias &#13;
•	atrial fibrillation &#13;
•	uncontrolled hypertension&#13;
•	type 2 diabetes&#13;
•	systemic disease and pulmonary that limited Sports&#13;
•	physical disabilities and any conditions limited Sports &#13;
•	severe valvular heart disease&#13;
•	known or suspected aortic dissection</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>121-122-12</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>121-Acute myocardial infarction 122-Subsequent myocardial infarction 123-Certain current complications following acute myocardial infarction 125-Chronic ischaemic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Second group will receive rehabilitation at home, take exercise program after being discharged from hospital, advised to exercise orderly and call doctor when having a problem. In order to motivate this group they will receive periodic telephone calls.&#13;
A pedometer device will give them to measure the amount of their activity objectively. An educated nurse will call them weekly and ask them about calorie intake and walking distance which measured by pedometer</i_keyword>
      <i_keyword>The study included two intervention groups and one control group. The first intervention group received hospital-based usual rehabilitation program from rehabilitation center of Tehran Heart Center</i_keyword>
      <i_keyword>The control group with the same schedule as group 2 will be followed up by phone. For Ethical principles, we will advise control group to received rehabilitation program from rehabilitation center of Tehran Heart Center or having regular physical activity at homes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score in Six minute walk test (MWT). Timepoint: 8 weeks after starting intervention. Method of measurement: Pedometr.</prim_outcome>
      <prim_outcome>Rate Pressure Product. Timepoint: 12 Weeks after starting intervention. Method of measurement: Exercise Test.</prim_outcome>
      <prim_outcome>Ejecton Fraction (EF). Timepoint: Based and  12 weeks later. Method of measurement: Echocardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality Of Life. Timepoint: Base and 12 weeks later. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Tei index. Timepoint: 12 weeks after intervention. Method of measurement: Echocardiography.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Base and 12 weeks later. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Systolic and Diastolic Blood Pressure. Timepoint: At base and 12 weeks after intervention. Method of measurement: Sphygmanimeter.</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 of research,Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-19</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Headquarters Building of Tehran University of Medical Sciences , Keshavarz "Blvd" Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
