<?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>IRCT20221031056349N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-18</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Eight Weeks of Aerobic and Combined Exercises in Middle-Aged Male Patients Undergoing Coronary Artery Bypass Graft Surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Eight Weeks Aerobic and Combined Exercise on Hemodynamic, Hemorheological, Structural and Functional indicators of the Heart in Middle-Aged Male Patients Undergoing Coronary Artery Bypass Graft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66626</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Other design features: In this study, Structural and Functional indicators of the Heart and Hemodynamic and Hemorheological variables are investigated simultaneously, Randomization description: The way to select the subjects is that people who are interested in participating in the trial are first invited. Then, the selection of the subjects is done in such a way that among the subjects, a researcher-made questionnaire containing information related to Name, Age, Height, Weight, History of sports activities, use of Sports supplements, Smoking, History of diseases and type of Drugs is prepared. And it is provided to the subjects for completion. After examining the answers of the subjects to the questions in the questionnaire, people who have a history of regular sports activity, participation in a weight training program, use of sports supplements, a history of pain, discomfort and surgery in the organs and musculoskeletal system, a history of smoking and limiting diseases If they do not have and meet the conditions to participate in the research, they will participate in the trial. At first, the subjects are visited and evaluated by a specialist doctor to ensure that they are not prohibited from participating in exercise groups. Then, 30 subjects between the ages of 45 and 65 are selected from among the qualified candidates. Each subject is assigned a number and randomly placed in a special group, Blinding description: At first, it is explained to all the subjects that they are participating in a study, and after the explanation, a consent form is obtained. But the subjects do not know which study group they are in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery occlusion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First intervention group, Aerobic exercises.Three sessions per week for 8 weeks and each session is one hour. Before and after the trial, Echocardiography (Structural and Functional indices of the Heart), Hemodynamic and Hemorheological factors are checked. Intervention 2: Intervention group: The Second  intervention group, Combined exercises group.Three sessions per week for 8 weeks and each session is one hour.Before and after the trial, Echocardiography (Structural and Functional indices of the Heart), Hemodynamic and Hemorheological factors are checked. Intervention 3: Control group: In this group, subjects do not exercise. Before and after the trial, Echocardiography (Structural and Functional indices of the Heart), Hemodynamic and Hemorheological factors are checked.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Means and standard deviations of descriptive data and pre- and post-trial data can be shared after de-identifying subjects.

When:
After the publication of the article

To whom:
Researchers of scientific and academic institutions

Conditions:
No new analysis is allowed. Researchers can refer to the results

Where to obtain:
To access the general results, please send an email to p.k.doulatyari@gmail.com

How to obtain:
After the request to the e-mail, it will be answered within a week at most

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Peyman Kaikhosro Doulatyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Ali Hospital, Shahid Beheshti Blvd</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847145</zip>
        <telephone>+98 83 3836 0295</telephone>
        <email>p.k.doulatyari@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Peyman Kaikhosro Doulatyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Ali Hospital, Shahid Beheshti Blvd</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847145</zip>
        <telephone>+98 83 3836 0295</telephone>
        <email>p.k.doulatyari@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men
Have undergone Coronary Artery Surgery within the previous 8 Weeks
The Heart's contractile strength should be above 40%
Take the same Heart medication
Surgery should be done by the same Surgeon and Echo by the same Cardiologist
No smoking for at least three months</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Musculoskeletal disease that hinders the Patient's activity
Smoking
Exercise activity in addition to the current study program
Moved from Kermanshah
Illness, Surgery or severe limiting pain
Taking sports supplements or special drugs</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>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First intervention group, Aerobic exercises.Three sessions per week for 8 weeks and each session is one hour. Before and after the trial, Echocardiography (Structural and Functional indices of the Heart), Hemodynamic and Hemorheological factors are checked.</i_keyword>
      <i_keyword>Intervention group: The Second  intervention group, Combined exercises group.Three sessions per week for 8 weeks and each session is one hour.Before and after the trial, Echocardiography (Structural and Functional indices of the Heart), Hemodynamic and Hemorheological factors are checked.</i_keyword>
      <i_keyword>Control group: In this group, subjects do not exercise. Before and after the trial, Echocardiography (Structural and Functional indices of the Heart), Hemodynamic and Hemorheological factors are checked.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The size and amount ofStructural indicators of the Heart. Timepoint: Before starting the study and 8 weeks later. Method of measurement: Echocardiography device.</prim_outcome>
      <prim_outcome>The level of functional indicators of the Heart. Timepoint: Before starting the study and 8 weeks later. Method of measurement: Echocardiography device.</prim_outcome>
      <prim_outcome>The percentage of people with high Hemodynamic indices. Timepoint: Before starting the study and 8 weeks later. Method of measurement: Sphygmomanometer.</prim_outcome>
      <prim_outcome>The percentage of people with high Hemorheological indices. Timepoint: Before starting the study and 8 weeks later. Method of measurement: laboratory equipment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Islamic Azad University of Kermanshah</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-07</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University- Kermanshah Branch</contact_name>
        <contact_address>End of Farhikhtegan Blvd, Ferdowsi Square Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
