<?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>IRCT20191117045462N20</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-27</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Effects of Manual Diaphragm Manipulation and Diaphragm  Release Technique in COPD</public_title>
      <acronym>Effects Of Manual Diaphragm Manipulation And Diaphragm Release In COPD</acronym>
      <scientific_title>Effects of Manual Diaphragm Manipulation and Diaphragm  Release Technique in COPD</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77948</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited into two groups labeled as 0 for group A and 1 for group B by simple random sampling through sealed opaque enveloped, Blinding description: The assessor physiotherapist and the patient both will be blinded. Although the consent form will be taken from the patient. But the patient will not be aware of the study. Accessor physiotherapist will be involved in the study. He or She must have 2 or 3 year experience in relevant domain. He will access the patient by defined outcome measure tools before the start of study at the end.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Obstructive Pulmonary Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: Manual Diaphragm Manipulation: Manual Diaphragm Manipulation will be performed four days a week on a regular basis for four weeks. Each session will consist of three sets of four repetitions, with a two minute break in between each set. Patient will be in supine position۔ Therapist positioned at the head side of the patient ۔ The therapist’s forearms will aligned towards the patient shoulders. Therapist made manual contact with the hypothenar region and the last three fingers bilaterally on the underside of the seventh to tenth rib costal cartilages. During the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, facilitating the elevation of the ribs. During exhalation, the therapist deepened the contact towards the inner costal margin, maintaining resistance. In the subsequent respiratory cycles, the therapist further deepened the contact inside the costal margin, adjusting it at specific points to ensure proper technique and effectiveness. Intervention 2: Intervention group B: Diaphragm Release Technique:  Diaphragm release techniques focus on stretching and mobilizing the diaphragm muscle to enhance its flexibility and function. This can include stretching exercises such as  Breath-hold Stretch، side stretch، seated diaphragmatic stretch، deep breathing and other therapeutic interventions aimed at improving diaphragmatic excursion and respiratory efficiency. The diaphragm release technique will be performed four days a week, with a rest period of two minutes in between each set of three sets of four repetitions. Every patient will be instructed to breathe as deeply and quietly as possible throughout the sessions, and they will all be attentively watched to look for any indicators that could compromise the study's ongoing continuity.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Umer Arshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>EXPERT CONSULTANT CLINIC  627, Khayaban e Jinnah,  Iqbal Avenue Cooperative Housing Society - Phase 1, Airline Society, Lahore Punjab.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>57600</zip>
        <telephone>+92 42 111 747 424</telephone>
        <email>omerkhushi0101@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Wajeeha Zia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54660</zip>
        <telephone>+92 42 111 747 424</telephone>
        <email>wajeeha_z@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with COPD according to the GOLD criteria
Age ranged from 45-65 years
Moderate COPD (50% &lt;Forced expiratory volume in first second "FEV1"&lt;80%, Forced expiratory volume in first second per forced vital capacity FEV1/FVC &lt;70% of predicted reversible airway obstruction)
Person who is not involved in any rehabilitation program at least 4 months prior to the study
No recent infectious exacerbations for the 2 months preceding the study</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of gastroesophageal reflux of any degree
Persistent hiccups within the previous three months
History of serious injury to the spine or thorax, including costal or spinal fractures or history of diaphragm surgery
Receiving long-term oxygen therapy
Patients with unstable hemodynamic parameters (HR, BP, Cardiac output and Stroke volume)
Patients who have undergone recent cardiothoracic or abdominal surgery
Patients with a recent history of chest wall or abdominal trauma
History of psychiatric illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic bronchitis</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 A: Manual Diaphragm Manipulation: Manual Diaphragm Manipulation will be performed four days a week on a regular basis for four weeks. Each session will consist of three sets of four repetitions, with a two minute break in between each set. Patient will be in supine position۔ Therapist positioned at the head side of the patient ۔ The therapist’s forearms will aligned towards the patient shoulders. Therapist made manual contact with the hypothenar region and the last three fingers bilaterally on the underside of the seventh to tenth rib costal cartilages. During the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, facilitating the elevation of the ribs. During exhalation, the therapist deepened the contact towards the inner costal margin, maintaining resistance. In the subsequent respiratory cycles, the therapist further deepened the contact inside the costal margin, adjusting it at specific points to ensure proper technique and effectiveness.</i_keyword>
      <i_keyword>Intervention group B: Diaphragm Release Technique:  Diaphragm release techniques focus on stretching and mobilizing the diaphragm muscle to enhance its flexibility and function. This can include stretching exercises such as  Breath-hold Stretch، side stretch، seated diaphragmatic stretch، deep breathing and other therapeutic interventions aimed at improving diaphragmatic excursion and respiratory efficiency. The diaphragm release technique will be performed four days a week, with a rest period of two minutes in between each set of three sets of four repetitions. Every patient will be instructed to breathe as deeply and quietly as possible throughout the sessions, and they will all be attentively watched to look for any indicators that could compromise the study's ongoing continuity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pulmonary function. Timepoint: Pre- Post Treatment. Method of measurement: Spirometer ( Diagnostic).</prim_outcome>
      <prim_outcome>Dyspnea. Timepoint: Pre- Post Treatment. Method of measurement: Modified Medical Research Council Scale (MMRC).</prim_outcome>
      <prim_outcome>Chest expansion. Timepoint: Pre- Post Treatment. Method of measurement: Measuring Tape.</prim_outcome>
      <prim_outcome>Exercise capacity. Timepoint: Pre- Post Treatment. Method of measurement: Six Minute Walk Test (6MWT).</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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-16</approval_date>
        <contact_name>Riphah college of rehabilitation &amp; Allied Health Sciences</contact_name>
        <contact_address>25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
