<?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>IRCT20220405054419N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-27</date_registration>
      <primary_sponsor>Riphah International University,Lahore</primary_sponsor>
      <public_title>Comparative effects of Diaphragmatic Stretch technique and Manual Release Technique on Diaphragmatic Excursion and pulmonary function testing in COPD patients.</public_title>
      <acronym>CEDSTMRTDEPFTCP</acronym>
      <scientific_title>Comparative effects of Diaphragmatic Stretch technique and Manual Release Technique on Diaphragmatic Excursion and pulmonary function testing in COPD patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62777</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Written informed consent will be taken. After enrollment
into study, patient will be allocated either to group A or
Group B by lottery method. No. of Chits will be equal to
total sample size, odd Numbers will be allocated to
Group A and even number will be allocated to Group B.
Each patient will be requested to draw a chit from the
box and after that patient will be recruited into either
Group A or Group B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic obstructive pulmonary disease is described as a condition in which their is a chronic inflammation of lungs that causes obstructed airflow from the lungs. It can cause many harmful symptoms such as breathing difficulty, cough, mucus (sputum) production and wheezing. Blueness of the lips or fingernail beds (cyanosis) is also one of the major symptom..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: will be treated with Manual Diaphragm Release Technique in which the participant was asked to lie supine with relaxed limbs. Positioned at the head of the patient, the therapist made manual contact with the hypothenar region and last three fingers bilaterally to the underside of the seventh to tenth rib costal cartilages. The therapist’s forearms were aligned towards the participant’s shoulders. In the inspiratory phase, the therapist was gently pulling the points of contact with both hands in the direction of the head and slightly laterally, accompanied the elevation of the ribs. During exhalation, the therapist’s contact was deepened towards the inner costal margin, maintaining resistance. In the subsequent respiratory cycles, the therapist deepened the Contact inside the costal margin. Intervention 2: Intervention group: will be treated with Diaphragmatic Stretch Technique in which the subjects were asked to sit erect for the intervention. The therapist standing behind the subject pass their hands around the thoracic cage, introducing fingers in the subcostal margins. The subject’s trunk was rounded slightly to relax the rectus abdominis. As the subject exhaled, the therapist easing their hands caudally grasped the lower ribs at the subcostal margin. This firm, but gentle, traction was maintained as the patient inhales.</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 There is no information decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arooma Muzummil</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no 23, Street no 62 Sadi Road Islampura Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 333 1472522</telephone>
        <email>arooma.bzu@gmail.com</email>
        <affiliation>Riphah International University, Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arooma Muzummil</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no 23, Street no 62 Sadi Road Islampura Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 333 1472522</telephone>
        <email>arooma.bzu@gmail.com</email>
        <affiliation>Riphah International University, Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with stable COPD of both genders who are referred for Physiotherapy by a pulmonologist/Physician in general Hospitals.
Patients with mild or moderate COPD according to the GOLD criteria, 2016.GOLD 1: Mild FEV1 ≥ 80% predicted, GOLD 2: Moderate 50% FEV1 &amp;lt; 80% Predicted.
Age range 40-60 years old patients.
gender both male and female.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with acute exacerbation of COPD
Patients with acute exacerbation of COPD systolic and &amp;lt; 60mmHg for diastolic and mean arterial pressure (MAP)&amp;lt;80mmHg).
Patients who have undergone recent cardiothoracic or abdominal surgery.
Patients who have a recent history of chest wall or abdominal trauma; substantial chest wall deformity.
History of psychiatric illness.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease with acute lower respiratory infection</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: will be treated with Manual Diaphragm Release Technique in which the participant was asked to lie supine with relaxed limbs. Positioned at the head of the patient, the therapist made manual contact with the hypothenar region and last three fingers bilaterally to the underside of the seventh to tenth rib costal cartilages. The therapist’s forearms were aligned towards the participant’s shoulders. In the inspiratory phase, the therapist was gently pulling the points of contact with both hands in the direction of the head and slightly laterally, accompanied the elevation of the ribs. During exhalation, the therapist’s contact was deepened towards the inner costal margin, maintaining resistance. In the subsequent respiratory cycles, the therapist deepened the Contact inside the costal margin.</i_keyword>
      <i_keyword>Intervention group: will be treated with Diaphragmatic Stretch Technique in which the subjects were asked to sit erect for the intervention. The therapist standing behind the subject pass their hands around the thoracic cage, introducing fingers in the subcostal margins. The subject’s trunk was rounded slightly to relax the rectus abdominis. As the subject exhaled, the therapist easing their hands caudally grasped the lower ribs at the subcostal margin. This firm, but gentle, traction was maintained as the patient inhales.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Diaphragm Strength. Timepoint: Before Treatment &amp; After treatment (6week). Method of measurement: Cirtometry.</prim_outcome>
      <prim_outcome>PFTs. Timepoint: Before and After treatment (6 week). Method of measurement: Spirometer.</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>Jinnah Hospital,Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date></approval_date>
        <contact_name></contact_name>
        <contact_address>   </contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-24</approval_date>
        <contact_name>Riphah International University</contact_name>
        <contact_address>28-M Quaid e Azam Industrial Estate Kot Lakhpat,Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
