<?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>IRCT20200204046373N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-20</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Physiotherapy techniques in post-CABG patients</public_title>
      <acronym>EISDBEPFCABG</acronym>
      <scientific_title>Effects of incentive spirometry and deep breathing exercises on pulmonary functions after coronary artery bypass grafting</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58958</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was applied. 
Individual unit of randomization
Parallel-group, concealed envelop method used
Subjects were randomly allocated to both groups based on a computer-generated randomized design. The randomization allocation was sealed in opaque envelopes, and the clinical coordinator did not know about the group to which the subject would be assigned until the envelopes were opened, Blinding description: The assessors and statisticians were blinded until the completion of the study. 
They were not aware of the interventions and groups. Concealed opaque envelopes were used for group assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Rotator cuff tendinopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: It received incentive spirometry in addition to routine physical therapy. Control group:  It received deep breathing exercises along with routine physical therapy. About 2000 shockwaves of 0.32mJ/mm2per treatment were given as 10 sessions for the first six weeks(two sessions/week). The regions of tendinopathy were identiﬁed by the US, and the corresponding surfaces of the regions were marked. ESWT was conducted using a ShockMaster 500 device (GymnaUniphy NV, Bilzen, Belgium)twice a week for six weeks in total. Each treatment consisted of 2000 shocks with a frequency of 120 shocks per minute. Each ESWTsession took about 15-20 minutes. ESWT application was performed on the supraspinatus, infraspinatus, teres minor, and subscapularis tendons. In successive treatments, an energy density of 0.32mJ/mm2 was used. An isotonic gel was used as an intermediate before the probe was applied to the patient’s shoulder, and no local anaesthetic was used. Intervention 2: Control group: Routine treatment was administered to the patients in both experimental and RPT groups and it included these items: general exercise plan included ROM exercises, stretching, and strengthening exercises of abductors and flexors of the shoulder) performed twice a week in 10 sessions.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is will be available on request</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arooj Fatima</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 km, Bhobatiyan chowk, Defence road</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>5400</zip>
        <telephone>092 42 341 4391882</telephone>
        <email>arooj.fatima1@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arooj Fatima</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 km, Bhobatiyan chowk, Defence road</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>5400</zip>
        <telephone>092 42 341 4391882</telephone>
        <email>arooj.fatima1@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Post-CABG patients
aged between 35-60 years
Both gender</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with previous history of lung disorder
bone tuberculosis
osteoarthritis
neurological diseases
osteoporosis patients
unstable hemodynamics</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: It received incentive spirometry in addition to routine physical therapy. Control group:  It received deep breathing exercises along with routine physical therapy. About 2000 shockwaves of 0.32mJ/mm2per treatment were given as 10 sessions for the first six weeks(two sessions/week). The regions of tendinopathy were identiﬁed by the US, and the corresponding surfaces of the regions were marked. ESWT was conducted using a ShockMaster 500 device (GymnaUniphy NV, Bilzen, Belgium)twice a week for six weeks in total. Each treatment consisted of 2000 shocks with a frequency of 120 shocks per minute. Each ESWTsession took about 15-20 minutes. ESWT application was performed on the supraspinatus, infraspinatus, teres minor, and subscapularis tendons. In successive treatments, an energy density of 0.32mJ/mm2 was used. An isotonic gel was used as an intermediate before the probe was applied to the patient’s shoulder, and no local anaesthetic was used.</i_keyword>
      <i_keyword>Control group: Routine treatment was administered to the patients in both experimental and RPT groups and it included these items: general exercise plan included ROM exercises, stretching, and strengthening exercises of abductors and flexors of the shoulder) performed twice a week in 10 sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygen saturation (SaO2). Timepoint: Day 1 and day 4 after CABG surgery. Method of measurement: The outcome measures are values of oxygen saturation (SaO2)by pulse oximetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Oxygen saturation. Timepoint: Day 1 and day 4 after CABG surgery. Method of measurement: measured by pulse oximetry.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-01</approval_date>
        <contact_name>Institutional Review Board Committee</contact_name>
        <contact_address>1 km, Bhobatiyan chowk, Defence road Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
