<?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>IRCT20220704055364N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-23</date_registration>
      <primary_sponsor>Faisal Institute of Health Sciences Faisalabad.</primary_sponsor>
      <public_title>Effects of preoperative Respiratory Muscle Training for improvement of postoperative Health Related Quality of Life in Mitral Valve Replacement patients”</public_title>
      <acronym></acronym>
      <scientific_title>Effects of preoperative Respiratory Muscle Training for improvement of postoperative Health Related Quality of Life in Mitral Valve Replacement patients”</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64610</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mitral valve Replacement is used to treat the diseased mitral valve..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1;Respiratory muscle training consisting of Segmental Breathing Exercise, huff-coughing techniques and instructions of flow-IS-based Incentive Spirometer,  10-15 repetitions  for five days and  three weeks. Intervention 2: Control group: ,Breathing exercises consisting of 10 deep breathing attempts, diaphragmatic breathing and pursing of the lip, 10-15 repetitions for five days and three weeks.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Umama Umar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>673-A,Canal Road E, A Block ,Peoples Colony no: 1,  Faisal Hospital , Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>009241856999</telephone>
        <email>Umamaumar450@gmail.com</email>
        <affiliation>Faisal Institute of Health Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Komal Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>673-A, Canal Road E, A Block Peoples colony, Faisal Hospital, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8536999</telephone>
        <email>fihsfsd@outlook.com</email>
        <affiliation>Faisal Institute of Health Sciences Faisalabad.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both male and female patients will be included.
Age 25-50 years.
Patients who are awaiting mitral valve repair/replacement.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with any other significant valvar or coronary artery diseases necessitating surgical intervention.
Patients who have chronic respiratory conditions.
Patients who have neurological deficits.
Patients who are morbid obese according to Body Mass Index.
Patients who reveal inconsistency with exercise protocol.
Patients with chronic renal insufficiency.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>02RG38Z</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mitral valve Replacement</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 1;Respiratory muscle training consisting of Segmental Breathing Exercise, huff-coughing techniques and instructions of flow-IS-based Incentive Spirometer,  10-15 repetitions  for five days and  three weeks.</i_keyword>
      <i_keyword>Control group: ,Breathing exercises consisting of 10 deep breathing attempts, diaphragmatic breathing and pursing of the lip, 10-15 repetitions for five days and three weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The EuroQol-5 D-5L (EQ-5D-5L),  is a most widely used generic tool to measure the health-related quality of life (HRQoL) and considered suitable for patients with pulmonary problems. Timepoint: 3time points including Baseline, After 3rd week, and postoperatively before discharge. Method of measurement: EuroQol-5D-5L will be measured by EuroQol-5D-5L Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The New York Heart Association classification is a straight forward system use for determining heart failure. It divides patients into four Classes: Class I can complete any activity requiring ≤ 7  Metabolic Equivalent, Class II can complete any activity requiring ≤ 5 Metabolic Equivalent, Class III can complete any activity requiring ≤ 2 Metabolic Equivalent ,Class IV cannot do or cannot complete any activity requiring at least less than ≥ 2  Metabolic Equivalent ,depending upon their limits during physical activity; these limitations/symptoms include normal breathing, varying degrees of shortness of breath and angina discomfort. Timepoint: 3 time points including Baseline, After 3rd week, and postoperatively before discharge. Method of measurement: NYHA Classification (Newyork Heart Association Classification) will be measured by NYHA grading system.</sec_outcome>
      <sec_outcome>Postoperative Duration of Mechanical Ventilation (hours) use was defined from the time the patient entered the ICU to the moment of extubation. Timepoint: 1 time postoperatively. Method of measurement: Postoperative Duration of Mechanical Ventilation will be measured in hours from patient entered the ICU to the moment of extubation.</sec_outcome>
      <sec_outcome>Postoperative Hospital Stay (Days) is the lenght of days patient stay in hospital after surgery. Timepoint: 1 time postoperatively. Method of measurement: Postoperative Hospital Stay (Days) will be measured from patient stay in hospital after surgery.</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>Self Financed</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-09</approval_date>
        <contact_name>Ethics committee of Government College university Faisalabad</contact_name>
        <contact_address>C389+CXH, Kotwali Rd, Gurunanakpura, Faisalabad, Punjab Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
