<?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>IRCT20180110038298N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-01</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Cardiac rehabilitation educational program on risk factors and functional capacity of patients with coronary artery disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Cardiac rehabilitation educational program on risk factors and functional capacity of patients with coronary artery disease in Ali ibn abitaleb hospital, Zahedan, 1397</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32171</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiovascular disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Includes 35 patients undergoing a cardiac rehabilitation program within twelve weeks. The program consists of four lecture sessions and a questionnaire that focuses on the risk factors for cardiovascular disease including blood sugar and lipids, and hypertension, which, prior to discharge, are dispensed in the first week after discharge. The second and third weeks are held. In addition, the patient follows a daily walking program at least three times a week during the study period, which increases the heart rate by 10% on a weekly basis. Before the intervention, and at the end of the twelfth week blood tests are performed, including blood sugar and blood lipids. Blood pressure, waist circumference and waist to hip ratio and distance traveled in the six-minute walk test are compared at the beginning and end of the study. Intervention 2: Control group: Includes 35 eligible patients who receive routine hospital training. Blood glucose and blood tests are done prior to discharge and at the end of the study. Record the blood pressure and distance traveled in the 6-minute walk test at the time of discharge and in the 12th week and compare with the intervention 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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Shabazi Dehsookhte</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Behdasht Blvd.,Mashahir square, Faculty of Nursing and Midwifery</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3344 2482</telephone>
        <email>shahbazi.azam92@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Yaghubi Nia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Behdasht Blvd.,Mashahir square, Faculty of Nursing and Midwifery</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3343 0059</telephone>
        <email>yaghoubinia@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of coronary artery disease is done by a specialist, confirming the results of diagnostic tests
The first hospital admission is due to coronary artery disease
Ejection fraction is between 25 to 40%
The hemodynamic status at the start of the rehabilitation program is stable
Age between 25 and 65 years old
Ability to walk without help
Reside in Zahedan City</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>There is no serious arrhythmia when the rehab program starts
Have not COPD, pulmonary artery pressure and right heart problems
Lack of history of heart surgery and not being a candidate for CABG</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Includes 35 patients undergoing a cardiac rehabilitation program within twelve weeks. The program consists of four lecture sessions and a questionnaire that focuses on the risk factors for cardiovascular disease including blood sugar and lipids, and hypertension, which, prior to discharge, are dispensed in the first week after discharge. The second and third weeks are held. In addition, the patient follows a daily walking program at least three times a week during the study period, which increases the heart rate by 10% on a weekly basis. Before the intervention, and at the end of the twelfth week blood tests are performed, including blood sugar and blood lipids. Blood pressure, waist circumference and waist to hip ratio and distance traveled in the six-minute walk test are compared at the beginning and end of the study.</i_keyword>
      <i_keyword>Control group: Includes 35 eligible patients who receive routine hospital training. Blood glucose and blood tests are done prior to discharge and at the end of the study. Record the blood pressure and distance traveled in the 6-minute walk test at the time of discharge and in the 12th week and compare with the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiac Rehabilitation educational Program. Timepoint: Before discharge and then the end of the study in the twelfth week. Method of measurement: blood sample, 6 minute walk test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood glucose. Timepoint: Before discharge and then the end of the study in the twelfth week. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Blood lipid profile. Timepoint: Before discharge and then the end of the study in the twelfth week. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Waist Circumference. Timepoint: Before discharge and then the end of the study in the twelfth week. Method of measurement: Measuring with meter.</sec_outcome>
      <sec_outcome>Waist–hip ratio. Timepoint: Before discharge and then the end of the study in the twelfth week. Method of measurement: The number obtained by dividing the waist circumference of the hip circumference.</sec_outcome>
      <sec_outcome>6 minute walk test. Timepoint: Before discharge and then the end of the study in the twelfth week. Method of measurement: The distance traveled in a six minute walk test per meter.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-27</approval_date>
        <contact_name>Ethics committee of zahedan university of medical Sciences</contact_name>
        <contact_address>NO. 1 , Daneshgah Ave., Hesabi Squ., Pardis complex , university of medical sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
