<?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>IRCT20211119053108N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-03</date_registration>
      <primary_sponsor>Shahid Rajaei Heart Center</primary_sponsor>
      <public_title>Respiratory Physiotherapy before Surgery and Pulmonary Complications</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Respiratory Physiotherapy before Surgery on Pulmonary Complications in Patients Undergoing Cardiac valve Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60247</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: The candidate for heart valve surgery will select the available method based on the inclusion criteria and randomly assign a block to one of the experimental (40) or control (40) groups. For random assignment to the experimental or control group, the blocking method will be used in the form of four random blocks. The letter A belongs to the intervention group and the letter B belongs to the control group. Based on. The sample size is 80 people. Blocking is used in the form of four blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pulmonary complications . cardiovascular patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The start of TFS physiotherapy is 15 days before surgery. In the clinic of Shahid Rajaei Hospital, pamphlets related to breathing exercises and incentive spirometry are provided to the patient and the necessary training on how to perform respiratory physiotherapy and use of incentive spirometry is given through lectures and shows. The patient is given. To ensure the effectiveness of the training, the patient is asked to once use the method of using incentive spirometry and how to perform respiratory physiotherapy in the presence of the researcher, and in case of problems at any stage, the training will be repeated.Preoperative physiotherapy techniques for patients will include the following: 1. Breathing exercises consisting of 10 attempts at deep breathing and diaphragmatic breathing 2. 10 breathing lip buds 3. Neck and shoulder exercises with emphasis on chest rehabilitation 4. Muscle tension exercises 5. Exercises to strengthen the muscles responsible for moving the shoulders back and forth (Shakoori et al., 2015). 6. Use of incentive spirometry (IS) (Respiflow ™ FS) and effective cough. Intervention 2: Control group: The usual hospital treatments are performed on the control 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:
Participant data

When:
6 months after printing the results

To whom:
People working in scientific institutes

Conditions:
In order to be used for scientific work

Where to obtain:
By email and phone number

How to obtain:
Send requests from individuals and then review and send responses

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati St., Kaleem Kashani St., Daryani Alley, No. 52, Unit 2</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۶۱۳۷۷۳۹۱۱</zip>
        <telephone>+98 21 3421 5785</telephone>
        <email>hamedbayati700@gmail.com</email>
        <affiliation>Shahid Rajaei Heart Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati St., Kaleem Kashani St., Daryani Alley, No. 52, Unit 2</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۶۱۳۷۷۳۹۱۱</zip>
        <telephone>+98 21 3421 5785</telephone>
        <email>hamedbayati700@gmail.com</email>
        <affiliation>Shahid Rajaei Heart Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are candidates for heart valve surgery (mitral, aortic or tricuspid)
No history of heart surgery
No neuromuscular disorders or cognitive disorders
No emergency surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction with participating in the study
Be lung and kidney healthy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>۰</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>۰</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The start of TFS physiotherapy is 15 days before surgery. In the clinic of Shahid Rajaei Hospital, pamphlets related to breathing exercises and incentive spirometry are provided to the patient and the necessary training on how to perform respiratory physiotherapy and use of incentive spirometry is given through lectures and shows. The patient is given. To ensure the effectiveness of the training, the patient is asked to once use the method of using incentive spirometry and how to perform respiratory physiotherapy in the presence of the researcher, and in case of problems at any stage, the training will be repeated.Preoperative physiotherapy techniques for patients will include the following: 1. Breathing exercises consisting of 10 attempts at deep breathing and diaphragmatic breathing 2. 10 breathing lip buds 3. Neck and shoulder exercises with emphasis on chest rehabilitation 4. Muscle tension exercises 5. Exercises to strengthen the muscles responsible for moving the shoulders back and forth (Shakoori et al., 2015). 6. Use of incentive spirometry (IS) (Respiflow ™ FS) and effective cough</i_keyword>
      <i_keyword>Control group: The usual hospital treatments are performed on the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determining and comparing the mean results of arterial blood gases in the intervention and control groups, before surgery and three days after surgery. Timepoint: Before surgery and 3 days later. Method of measurement: Measurement using arterial blood gas test results.</prim_outcome>
      <prim_outcome>• Determination and comparison of mean respiratory volume using incentive spirometry in the intervention and control groups, before, three days and six days after surgery. Timepoint: Before surgery and 3 days later and 6 days later. Method of measurement: Based on the volume determined by the incentive spirometer.</prim_outcome>
      <prim_outcome>Determination of clinical and radiographic symptoms of pneumonia and atelectasis in the intervention group compared with the control group before, three days and six days after surgery. Timepoint: Before surgery and 3 days later and 6 days later. Method of measurement: Based on clinical examination and chest x-ray.</prim_outcome>
      <prim_outcome>Determining and comparing the mean duration of intubation and hospitalization time in the intensive care unit and hospitalization in the intervention and control groups. Timepoint: Duration of hospitalization. Method of measurement: Based on hospital information.</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>Personal</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-09</approval_date>
        <contact_name>Ethics Committee of Shahid Rajaei Heart Center</contact_name>
        <contact_address>Tehran - Vali Asr St. (AS) - Next to Mellat Park - Corner of Niayesh Shahid Rajaei Cardiovascular Training, Research and Treatment Center Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
