<?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>IRCT20160523028028N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-19</date_registration>
      <primary_sponsor>Azarbaijan Shahid Madani University</primary_sponsor>
      <public_title>Stretching- Breathing Exercises and Cardiac Rehabilitation</public_title>
      <acronym></acronym>
      <scientific_title>The Acute and Chronic Effect of Stretching- Birthing Exercise Training on Clinical Outcomes in the First Phase of Cardiac Rehabilitation in Patients Undergoing Coronary Artery Bypass Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50216</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Available eligible samples will be randomly assigned to the intervention group (recipient of stretching breathing movements) and the control group (recipient of hospital routine intervention) by assigning a 1: 1 ratio. Random allocation sequence will be done by a non-research person using RAS (Random Allocation Software) and random blocking will be done using two and four blocks for allocation in two groups (intervention group and control group). The allocation will be done based on the sequence generated using matte, closed and identical envelopes numbered from number 1 to the end. The first person to enter the study will be given envelope number 1 and this process will continue until the end.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with coronary artery bypass graft surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Performing stretching-breathing exercises for five days, twice a day (morning and evening). The intensity of training will be less than 13 according to the recommendations of the American College of Sports Medicine (ACSM) and the Borg RPE Scale, and according to the heart rate, the target heart rate will be less than, 30 beats + resting heart rate. Intervention 2: Control group: Recipient of routine hospital intervention.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Zarneshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azarbaijan Shahid Madani University , 35 Km Tabriz- Maragheh Road, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5375171379</zip>
        <telephone>+98 41 3432 7505</telephone>
        <email>Zarneshan@azaruniv.ac.ir</email>
        <affiliation>Azarbaijan Shahid Madani University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Zarneshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azarbaijan Shahid Madani University , 35 Km Tabriz- Maragheh Road, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5375171379</zip>
        <telephone>+98 41 3432 7505</telephone>
        <email>Zarneshan@azaruniv.ac.ir</email>
        <affiliation>Azarbaijan Shahid Madani University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Non-emergency heart surgery
Absence of arrhythmia and angina
Stable hemodynamic status</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having neuromuscular disorders
Having cognitive disorders
Having severe lung disease
Having renal dysfunction
Injection fraction less than 35%
Have a history of heart surgery</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: Intervention group: Performing stretching-breathing exercises for five days, twice a day (morning and evening). The intensity of training will be less than 13 according to the recommendations of the American College of Sports Medicine (ACSM) and the Borg RPE Scale, and according to the heart rate, the target heart rate will be less than, 30 beats + resting heart rate.</i_keyword>
      <i_keyword>Control group: Recipient of routine hospital intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Arterial blood oxygenation changes. Timepoint: Before, immediately and five days after the intervention. Method of measurement: Pulse oximetry and evaluation of arterial blood gases using arterial sampling.</prim_outcome>
      <prim_outcome>Hemodynamic changes. Timepoint: Before, immediately and five days after the intervention. Method of measurement: Monitoring device.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before, immediately, the first day, the second day, the third day, the fourth and the fifth day of operation. Method of measurement: Anxiety assessment was performed by the Spielberger State-Trait Anxiety Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Arterial blood of mean oxygen pressure Pao2. Timepoint: Before, immediately, five days later. Method of measurement: Evaluation of arterial blood gases using arterial sampling.</sec_outcome>
      <sec_outcome>Arterial blood of mean Carbon dioxide pressure PaCo2. Timepoint: Before, immediately, five days later. Method of measurement: arterial blood of mean Carbon dioxide pressure PaCo2.</sec_outcome>
      <sec_outcome>Arterial blood oxygen saturation Sao2. Timepoint: Before, immediately, five days later. Method of measurement: Pulse oximetry.</sec_outcome>
      <sec_outcome>Blood  Pressure. Timepoint: Before, immediately, five days later. Method of measurement: Monitoring device.</sec_outcome>
      <sec_outcome>Heart Rate. Timepoint: Before, immediately, five days later. Method of measurement: Monitoring device.</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>Azarbaijan Shahid Madani University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-27</approval_date>
        <contact_name>•Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>تبریز، خیابان آزادی ، خیابان گلگشت Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
