<?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>IRCT20101019004971N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-22</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Survey efficiency of cardiac rehabilitation program after coronary artery bypass graft on respiratory characteristics</public_title>
      <acronym>GUMS</acronym>
      <scientific_title>Survey efficiency of the cardiac rehabilitation program after coronary artery bypass graft on respiratory characteristics.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31072</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: samples dispart into two groups (control and case) : first group receive incentive spirometry like routine rehabilitation and second group receive CPAP with mask 4-6 cmH2o until 35 minute (the first 5 minute allocate to reduce stress and adaptation with this device ) beside incentive spirometry . after 2 hours , progressive exercises as walking start in the first day, 5-10 minutes (base on patients tolerance ) , in the second day 10-15 minutes and in the third day 15 minutes and more . at the end of each cession all of the patients will evaluate with modified Borg scale CR-10 for dyspnea and RPE scale for leg effort . In the forth day the final results will evaluate with spirometery parameters , Randomization description: randomized a block size of 2.</study_design>
      <phase>1</phase>
      <hc_freetext>efficiency of cardiac rehabilitation program after coronary artery bypass graft on respiratory characteristics.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group patients besides receiving routine incentive spirometery in their cardiac rehabilitation program use Continuous Positive Airway Pressure mask(CPAP) till 35 minutes, due to patients tolerance before walking (the first 5 minutes related to reduce stress and adaptation) . In the first day, exercises start as walking (due to patients tolerance) 5-10 minutes , in the second day 10-15 ,and in the third day 15 minutes and more after 2 hours pass from using  CPAP. Intervention 2: Control group: In this group patients receive incentive spirometery and deep breathing exercises for 30 minutes  and then exercises start as walking (due to patients tolerance) 5-10 minutes , in the second day 10-15 ,and in the third day 15 minutes and more after 2 hours pass from using  incentive spirometery .</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:
Only a portion of the dataabout the outcome of interventions. will be shared. 
Personal information will not be absolutely shared.

When:
The Six Months after   publish of results

To whom:
University Researchers

Conditions:
With formal request and Announcing the source of the data and Permission from researchers use of is allowed.

Where to obtain:
Email to the moderator of the project, Mohammad Taghi Moghaddam Nia
Moghadamnia@gums.ac.ir

How to obtain:
After contacting  to the email of moderator of project,the request  will be reviwe and  answered within 3 business days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Taghi Moghadamnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No, 1, Havashenasi Ave, Moalem Blvd, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4153754987</zip>
        <telephone>+98 31 3326 0090</telephone>
        <email>moghadamnia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Taghi Moghadamnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1 Havashenasi Ave., Moalem Blvd.,Rasht., Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4153754987</zip>
        <telephone>+98 13 3326 0090</telephone>
        <email>Moghadamnia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No Emergency Operation
No CABG history in the past
clinical diagnosis of coronary artery disease, who underwent elective coronary Artery bypass graft (CABG) with cardiopulmonary bypass, a median sternotomy incision and use of a saphenous vein, internal thoracic artery, or radial artery grafts
No use of intra-aortic balloon pump
No use of permanent pacemaker
Ability to perform exercise according to our protocol
No valvular heart disease,chronic obstructive pulmonary disease
No respiratory problems that cause to add length of intensive care unit stay
No Atrial fibrilation arrhythmia and use of Amiodarone protocle</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unstable angina
chronic disturbances in heart rhythm
significant acute arrhythmias
Do not tolerate Continuous Positive Airway Pressure (CPAP) with patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischemic heart disease</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: In this group patients besides receiving routine incentive spirometery in their cardiac rehabilitation program use Continuous Positive Airway Pressure mask(CPAP) till 35 minutes, due to patients tolerance before walking (the first 5 minutes related to reduce stress and adaptation) . In the first day, exercises start as walking (due to patients tolerance) 5-10 minutes , in the second day 10-15 ,and in the third day 15 minutes and more after 2 hours pass from using  CPAP.</i_keyword>
      <i_keyword>Control group: In this group patients receive incentive spirometery and deep breathing exercises for 30 minutes  and then exercises start as walking (due to patients tolerance) 5-10 minutes , in the second day 10-15 ,and in the third day 15 minutes and more after 2 hours pass from using  incentive spirometery .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dyspnea in patients who reveived score above 5 in Modified Category Ratio-10 (CR-10). Timepoint: At the end of the first to third sessions after intervention. Method of measurement: Scoring in Modified Category Ratio-10 (CR-10).</prim_outcome>
      <prim_outcome>Leg effort in patients who reveived score above 15 in Rate of Perceived Exertion (RPE- Scale). Timepoint: At the end of the first to third sessions after intervention. Method of measurement: Scoring in Rate of Perceived Exertion (RPE- Scale).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Spirometery parameters changes. Timepoint: In the forth session. Method of measurement: Spirometery.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-11</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology of Guilan University of Medical Sciences ., across 17 shahahrivar hospital., shahid Siadati  Ave., Namju Blvd., Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
