<?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>IRCT201610085136N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-04</date_registration>
      <primary_sponsor>Vice Chancellor Of Research Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Effects of cardiac rehabilitation on inflammation</public_title>
      <acronym></acronym>
      <scientific_title>Effects of acute and chronic aerobic exercise training on vascular and systemic inflammatory biomarkers in patients with coronary artery disease after revascularization interventions</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5466</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>Diseases of the circulatory system.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group:  . The cardiac rehabilitation comprise 24 sessions of exercise, schedule over 8 weeks in the Cardiac Rehabilitation Center of SHahid Beheshti Hospital (Kashan, Iran).  Each session last 60 minutes and included 10-20 minutes of warm-up followed by 20-40 minutes of aerobic exercise and a 10-minute cool-down. According to the determined risk, the intensity of exercise was calculated as 65-75% of maximum heart rate achieve on the exercise test. The exercise will perform under electrocardiographic monitoring if the patient was at high risk. All patients receive psychological, nutritional, and smoking cessation recommendations. Intervention 2: Control group: patients in this group will have their ordinary medications, and life style.</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>Fatemeh Basati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mohaghagh Ardebili University, Daneshgah Blvd,</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2298 9007</telephone>
        <email>basatifatemeh@yahoo.com; fatemeh.basati1987@gmail.com</email>
        <affiliation>Mohaghagh Ardebili University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Basati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mohaghagh Ardebili University, Daneshgah Blvd,</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2298 9007</telephone>
        <email>basatifatemeh@yahoo.com    ;       fatemeh.basati1987@gmail.com</email>
        <affiliation>Mohaghagh Ardebili University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Exclusion criteria: Patients were excluded if they have congestive failure;  immnomodulatory or anti-inflammatory medications other than Aspirin; or known history of immune related disorders; unstable angina; resting systolic blood pressure &gt;200 mmhg or diastolic blood pressure&gt;10mmhg; uncontrolled bradycardia or tachycardia.&#13;
Inclusion criteria:history of CABG and PCI; have ability to present in cardiac rehabilitation program; not having any physical exercise out of cardiac rehabilitation program; cardiac rehabilitation start 2 month after CABG and 1 month after PCI</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20-I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischaemic heart diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group:  . The cardiac rehabilitation comprise 24 sessions of exercise, schedule over 8 weeks in the Cardiac Rehabilitation Center of SHahid Beheshti Hospital (Kashan, Iran).  Each session last 60 minutes and included 10-20 minutes of warm-up followed by 20-40 minutes of aerobic exercise and a 10-minute cool-down. According to the determined risk, the intensity of exercise was calculated as 65-75% of maximum heart rate achieve on the exercise test. The exercise will perform under electrocardiographic monitoring if the patient was at high risk. All patients receive psychological, nutritional, and smoking cessation recommendations.</i_keyword>
      <i_keyword>Control group: patients in this group will have their ordinary medications, and life style.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PTX3. Timepoint: before and 30 min after one session submaximal aerobic exercise, and after 8 weeks cardiac rehabilitation program. Method of measurement: Human Pentraxin 3 Elisa Kit 96t - Zellbio Germany.</prim_outcome>
      <prim_outcome>VCAM-1. Timepoint: before and 30 min after one session submaximal aerobic exercise, and after 8 weeks cardiac rehabilitation program. Method of measurement: Human VCAM-1 Elisa Kit 96t - Diaclone France.</prim_outcome>
      <prim_outcome>CRP. Timepoint: before and 30 min after one session submaximal aerobic exercise, and after 8 weeks cardiac rehabilitation program. Method of measurement: Pars Azmon kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: before and after intervention. Method of measurement: balance scales.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: before and after intervention. Method of measurement: weight divided by height square(kg/m2).</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: before and after intervention. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: before and after intervention. Method of measurement: sphygmomanometer.</sec_outcome>
      <sec_outcome>Total cholestrol. Timepoint: before and after intervention. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>HDL- cholestrol. Timepoint: before and after intervention. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>LDL-cholestrol. Timepoint: before and after intervention. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: before and after intervention. Method of measurement: blood analysis.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice Chancellor Of Research Mohaghegh Ardebili University</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 Kashan University of Medical Sciences</source_name>
      <source_name>Vice Chancellor Of Research Mohaghegh Ardebili University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-01</approval_date>
        <contact_name>Kashan University of Medical Sciences Ethic Committee</contact_name>
        <contact_address>,Kashan University of Medical Sciences, Medicine faculty Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
