<?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>IRCT20220704055364N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-18</date_registration>
      <primary_sponsor>Faisal Institute of Health Sciences Faisalabad</primary_sponsor>
      <public_title>Effects of Prehabilitation Resistance Exercise in mild to moderate clinically frail patients for improving postoperative outcomes in Coronary Artery Bypass Grafting patients.</public_title>
      <acronym>CABG</acronym>
      <scientific_title>Effects of Prehabilitation Resistance Exercise in mild to moderate clinically frail patients for improving postoperative outcomes in Coronary Artery Bypass Grafting patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68582</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>Coronary Artery Bypass Grafting (CABG) is a medical treatment to increase blood flow to the heart is  often known as heart bypass surgery..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1; Resistance Training Group will perform resistance exercises of major mucle groups of upper and lower limbs which consists of Shoulder over head press, Biceps Curl, Knee lift and Hamstring Curls exercises will be provided for 2 times a day , 10-15 repetitions, five days and for three weeks. Intervention 2: Control group 2; Conventional Group will perform Early Mobilization and Deep Breathing exercises which includes Diaphragmatic Breathing with pursing of lips  will be provided for 2 times a day , 10-15 repetitions, five days and for 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 Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Komal Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal Institute of Health Sciences Faisalabad Full name of responsible person Dr Komal Tariq Street address 673-A, Canal Road E, A Block Peoples colony, Faisal Hospital, Faisalabad  Email fihsfsd@outlook.com</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>Patients between the ages of 40-65 Years.
Patients who are awaiting Coronary artery bypass grafting.
Patients who are willing to participate in study.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are suffering from chronic respiratory conditions like asthma,chronic obstructive pulmonary disease and intersitial lung disease.
Patients suffering from chronic renal insufficiency.
Patients with endocrine abnormalities e.g hypo and hyperthyroidism.
Patients with concomitant valve disease,Anemia,pacemaker reliance and obesity according to Body Mass Index will be excluded .</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1; Resistance Training Group will perform resistance exercises of major mucle groups of upper and lower limbs which consists of Shoulder over head press, Biceps Curl, Knee lift and Hamstring Curls exercises will be provided for 2 times a day , 10-15 repetitions, five days and for three weeks.</i_keyword>
      <i_keyword>Control group 2; Conventional Group will perform Early Mobilization and Deep Breathing exercises which includes Diaphragmatic Breathing with pursing of lips  will be provided for 2 times a day , 10-15 repetitions, five days and for three weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Clinical Frailty Scale (CFS) is a frailty instrument based on judgement that assesses key areas such as comorbidity, function, and cognition to produce a frailty score ranging from 1 (extremely fit) to 9  (terminally ill). Timepoint: 3time points including Baseline, After 3rd week and Postoperatively  before discharge . Method of measurement: CFS will be measured by Clinical Frailty Scale Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The six-minute walk test (6MWT) calculates a person's maximum walking distance over the course of six minutes on a level, firm surface. Timepoint: 3time points including Baseline, After 3rd week and Postoperatively before discharge. Method of measurement: 6 Minute Walk Test will be measured by Distance Covered in 6 Minute Walk .</sec_outcome>
      <sec_outcome>Heart rate is define as the rate of heartbeat."The average heart rate is 72 beats per minute.". Timepoint: 3time points including Baseline, After 3rd week and Postoperatively before discharge. Method of measurement: Heart Rate will be measured by pulse Oximetry.</sec_outcome>
      <sec_outcome>The oxygen saturation test determines how much oxygen is carried by your blood's haemoglobin. Humans' arterial blood oxygen saturation values are typically between 97 and 100 percent. Timepoint: 3time points including Baseline, After 3rd week and Postoperatively before discharge. Method of measurement: Pulse oximetry will be used to measured Oxygen Saturation.</sec_outcome>
      <sec_outcome>Ventilation Duration(hours) is the time from the patient entered the ICU to the time of extubation. Timepoint: 1 time postoperatively. Method of measurement: Ventilation Duration will be measured in hours from the patient entered the ICU to the time of extubation.</sec_outcome>
      <sec_outcome>Postoperative Hospital Stay (Days) is the days patient stay in hospital after surgery. Timepoint: 1 time postoperatively. Method of measurement: Postoperative Hospital Stay (Days) will be measured  by days 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>2023-01-25</approval_date>
        <contact_name>Ethics committee of Faisal institute of health sciences, faisalabad</contact_name>
        <contact_address>673-A Lower Canal Road E, Block A peoples Colony no 1, Faisal Hospital, Faisalabad. Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
