<?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>IRCT20180625040234N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-17</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of respiratory muscle training on hospital and ICU stay in patients undergoing coronary and valves surgery</public_title>
      <acronym>تقویت عضلات تنفسی قبل از جراحی قلب</acronym>
      <scientific_title>The effect of respiratory muscle training on hospital and ICU stay in patients undergoing coronary and valves surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>190</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32234</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Individuals were selected using Permuted Block randomization method. then were divided  in two groups including muscle training and pulmicort combivent, and control group which will receive only pulmonary combivent  and both groups will be evaluated by breathing test and SF36 questionnaire after the study.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Mechanical complication of coronary artery bypass and  valve.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Inspiratory muscle training (IMT) and treated with pulmicort and combivent inhaller.Patients return to the recovery at least 2 weeks before surgery.At the first session patients were trained regarding the  respiratory muscle training which should do at home and  pimax (maximum respiratory capacity) was measured. After one week patients referred to evaluate and fix the problems which they faced.At the end of two weeks, pimax (maximum respiratory capacity) was measured. Intervention 2: Control group:  pimax (maximum respiratory capacity) was measured and treated with pulmicort and combivent inhaller.</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:
It is possible to share the information regarding the main consequence .

When:
The publication of this research work will start after the end of the year 1399.

To whom:
Our study data will be available to researchers and all medical doctors and medical students.

Conditions:
It is authorized to use  this scheme for upcoming research works and  promoting the patients' treatment.

Where to obtain:
Applicants can visit the doctor Niyazi at Tehran Heart Center

How to obtain:
After finishing the work and publishing the article the work can be referred and cited.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sepideh Niyazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Heart Center,North Kargar St.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713138</zip>
        <telephone>+98 88 0296 0069</telephone>
        <email>sepide.niyazi.sn@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Ahmadi Tafti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Heart Center,North Kargar St.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713138</zip>
        <telephone>+98 0218802973</telephone>
        <email>hosseinahmaditafti@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Patients who are  at the risk of postoperative pulmonary complications
are on the same list of surgical procedures for switching vessels and valves.
The study is conducted in the waiting period for surgery and the results will be measured before surgery. The risk group includes patients over 70 years of age and a history of diabetes and history of smoking and pulmonary disease, (COPD), BMI greater than 27, and impaired pulmonary function (FEV1 &lt;80% and FEZ1 / FVC &lt;70%).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age over 70 years
respiratory or pulmonary infections
lack of cooperation in the practice
lung surgery history
Cardiovascular instability and exercise induced bronchospasm
The use of immunosuppressive drugs 30 days before surgery
Spontaneous pneumothorax history</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T82.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mechanical complication of coronary artery bypass graft and biological heart valve graft</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Inspiratory muscle training (IMT) and treated with pulmicort and combivent inhaller.Patients return to the recovery at least 2 weeks before surgery.At the first session patients were trained regarding the  respiratory muscle training which should do at home and  pimax (maximum respiratory capacity) was measured. After one week patients referred to evaluate and fix the problems which they faced.At the end of two weeks, pimax (maximum respiratory capacity) was measured.</i_keyword>
      <i_keyword>Control group:  pimax (maximum respiratory capacity) was measured and treated with pulmicort and combivent inhaller.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maximum strength of the respiratory muscles. Timepoint: Before and after breathing exercises. Method of measurement: Using the power breathe device.</prim_outcome>
      <prim_outcome>Duration of admission to ECU. Timepoint: Since the transfer to ECU until clearance. Method of measurement: Patient File.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-13</approval_date>
        <contact_name>School of medicine - Tehran university of medical sciences</contact_name>
        <contact_address>Poursina ave., 6th floor, school of Medicine, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
