<?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>IRCT20240313061281N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-23</date_registration>
      <primary_sponsor>Shahid Rajaei Cardiovascular, Medical and Research Institute</primary_sponsor>
      <public_title>Investigating the effect of yoga breathing exercises on respiratory and hemodynamic indicators of patients after coronary artery bypass graft surgery</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of yoga breathing exercises on respiratory and hemodynamic indicators of patients after coronary artery bypass graft surgery: a Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76927</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: Random block method with block size 4 is used for random allocation. The random list will be created by the web-based software and the results will be provided to the principal investigator in sealed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients after coronary artery bypass graft surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving the routine program, the intervention group will receive yoga breathing exercises that include three breaths: 1- Complete breathing, 2- Kapalabhati breathing, and 3-NadiShodhana breathing during four days. Cardiovascular indicators (systolic blood pressure, diastolic blood pressure, heart rate) (and respiratory) respiratory rate, PFM, percentage of oxygen saturation and the values obtained from the interpretation of arterial blood gases including PH, HCO3, PO2, PCO2, BE) before the intervention and 2 hours after the first and 2 hours after the second intervention in the ICU. In addition, two other times of intervention and only the measurement of the peak flowmeter will be done 2 hours after the intervention, after leaving the ICU and in the ward on the third and fourth days after the surgery. Intervention 2: Control group:they are subjected to a routine rehabilitation program after CABG surgery, which includes respiratory physiotherapy and incentive spirometry. The cardiovascular and respiratory indicators of the control group are also measured at the same time as 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after de-identifying individuals.

When:
Access starts 6 months after results are published

To whom:
Data will be available to researchers working in academic and scientific institutions and people working in industry.

Conditions:
Performing all analyzes on the delivered data is allowed.

Where to obtain:
Email to 'MahnazMoradi 628@gmail.com'
This email is owned by Mahnaz Moradi.

How to obtain:
The applicant should send request, which includes the reason and motive for accessing the documents and data files, to the mentioned email address. After reviewing the request, the documents will be sent within a few days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.45, Akbarzare AIIey, Golkhane St, Khane isfahan Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8194957966</zip>
        <telephone>0098314204313</telephone>
        <email>Mahnazmoradi628@gmail.com</email>
        <affiliation>Shahid Rajaei Cardiovascular, Medical and Research Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.45, Akbarzare AIIey, Golkhane St, Khane isfahan Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8194957966</zip>
        <telephone>+98 31 3420 4313</telephone>
        <email>mahnazmoradi628@gmail.com</email>
        <affiliation>Rajaie Cardiovascular Medical and Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Extubated patients who undergo elective coronary artery bypass surgery and have not undergone emergency coronary artery bypass surgery
Consent to participate in the study
Patients with cardiac output fraction &gt; 35%
Patients in the age range of 30-70 years
Non-dialysis patients
Patients who are intubated for less than 24 hours.
COPD patients who are not in stage 4 according to FEV1 before surgery (stage 4-very severe-FEV1 ≤30%).</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness or withdrawal from the study at any time
Patients who experience unstable hemodynamic conditions during exercise (heart rate above 100 or below 50, systolic pressure drop below 100, dizziness or restlessness, loss of consciousness and respiratory distress with a respiratory rate above 24)
Patients who return to the operating room due to bleeding, tamponade and unstable conditions
Patients who suffer from cardiac arrhythmia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to receiving the routine program, the intervention group will receive yoga breathing exercises that include three breaths: 1- Complete breathing, 2- Kapalabhati breathing, and 3-NadiShodhana breathing during four days. Cardiovascular indicators (systolic blood pressure, diastolic blood pressure, heart rate) (and respiratory) respiratory rate, PFM, percentage of oxygen saturation and the values obtained from the interpretation of arterial blood gases including PH, HCO3, PO2, PCO2, BE) before the intervention and 2 hours after the first and 2 hours after the second intervention in the ICU. In addition, two other times of intervention and only the measurement of the peak flowmeter will be done 2 hours after the intervention, after leaving the ICU and in the ward on the third and fourth days after the surgery.</i_keyword>
      <i_keyword>Control group:they are subjected to a routine rehabilitation program after CABG surgery, which includes respiratory physiotherapy and incentive spirometry. The cardiovascular and respiratory indicators of the control group are also measured at the same time as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of peak flowmeter. Timepoint: in four times, before the intervention and 2 hours after the intervention on the first to fourth days. Method of measurement: Peak flowmeter device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Respiratory rate per minute. Timepoint: before the intervention and two hours after training on the first and second days. Method of measurement: Observation of the patient's chest.</sec_outcome>
      <sec_outcome>Arterial oxygen saturation percentage. Timepoint: before the intervention and two hours after training on the first and second days. Method of measurement: Pulse Oximeter.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: before the intervention and two hours after training on the first and second days. Method of measurement: Pulse Oximeter.</sec_outcome>
      <sec_outcome>Systolic and diastolic arterial blood pressure. Timepoint: before the intervention and two hours after training on the first and second days. Method of measurement: Saadat brand monitor blood pressure gauge.</sec_outcome>
      <sec_outcome>Partial pressure of carbon dioxide. Timepoint: before the intervention and two hours after training on the first and second days. Method of measurement: It is performed via arterial blood gas.</sec_outcome>
      <sec_outcome>Partial pressure of oxygen. Timepoint: before the intervention and two hours after training on the first and second days. Method of measurement: It is performed via arterial blood gas.</sec_outcome>
      <sec_outcome>Base excess. Timepoint: before the intervention and two hours after training on the first and second days. Method of measurement: It is performed via arterial blood gas.</sec_outcome>
      <sec_outcome>Bicarbonate. Timepoint: before the intervention and two hours after training on the first and second days. Method of measurement: It is performed via arterial blood gas.</sec_outcome>
      <sec_outcome>Potential of hydrogen. Timepoint: before the intervention and two hours after training on the first and second days. Method of measurement: It is performed via arterial blood gas.</sec_outcome>
      <sec_outcome>Safety endpoints and complications. Timepoint: During the patient's hospitalization. Method of measurement: Observation of patient.</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>Shahid Rajaei Cardiovascular, Medical and Research Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-11</approval_date>
        <contact_name>Research Ethics committee of Rajaie Cardiovascular, Medical and Research Institiue</contact_name>
        <contact_address>NO.1115119969, valiasr St., Hashemi Rafsanjani Hwy, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
