<?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>IRCT20191117045462N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-30</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>EFFECTS OF DIAPHRAGMATIC STRETCH WITH AND WITHOUT RIB CAGE MOBILIZATION ON CHEST EXPANSION, DYSPNEA, PULMONARY FUNCTION TEST AMONG COPD PATIENTS</public_title>
      <acronym>EDSWRMCEDPFTA</acronym>
      <scientific_title>EFFECTS OF DIAPHRAGMATIC STRETCH WITH AND WITHOUT RIB CAGE MOBILIZATION ON CHEST EXPANSION, DYSPNEA, PULMONARY FUNCTION TEST AMONG COPD PATIENTS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73245</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Convenient sampling technique will be used to recruit the COPD patients in the study and then they will be divided into two groups by simple random sampling through sealed opaque enveloped, Blinding description: Participants will be aware of the research but they will not be aware of the groups and study hypothesis.  So, we will divide the participants into two different groups and they will not have any knowledge about these techniques and objective of the study. So, the participants will be blinded. The second one assessor therapist will do the assessment before and after the treatment. So, the assessor therapist will not be aware of your objective and research project.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Chronic Bronchitis. Condition 2: Emphysema.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Diaphragmatic stretch with rib cage mobilization                                        Diaphragmatic Stretch Technique: The diaphragmatic stretch techniques will be applied on patient. Patient will be positioned in seated with your knees bent and feet flat on the floor. Place one hand on your chest, and the other on your belly. Take a deep breath in through your nose and focus on expanding your belly, allowing it to push out against your hand. Hold for a few seconds and then exhale slowly through your mouth, contracting your belly muscles as you do so. The treatment duration will be 10 minutes, once a day, 5 days per week for 2 weeks.                                                                                                                          Rib Cage Mobilization: Rib cage mobilization will be applied on patients in the seated position, the patients remained seated on the stretcher, keeping the feet on the floor, while the therapist stood in front of him or her. The patient’s head (frontal region) was positioned over his or her overlapping arms, which were placed on the therapist’s trunk. The therapist then positioned his or her fingertips at the costal angles (bilaterally), moving from the lateral region to the anterior midline throughout the patient’s inspiration and returning to the initial position on expiration. The therapist’s fingers were then placed 1 level below the rib, repeating this procedure until his or her fifth finger reached the 10th rib. This technique was then carried out toward the 1st rib, completing a treatment cycle. Another cycle was conducted after a 1-minute rest period. The treatment duration will be 20 minutes, once a day, 5 days per week for 2 weeks. Intervention 2: Control group: Diaphragmatic stretch                                                                                     Diaphragmatic Stretch Technique: The diaphragmatic stretch techniques will be applied on patient. Patient will be positioned in seated with your knees bent and feet flat on the floor. Place one hand on your chest, and the other on your belly. Take a deep breath in through your nose and focus on expanding your belly, allowing it to push out against your hand. Hold for a few seconds and then exhale slowly through your mouth, contracting your belly muscles as you do so. The treatment duration will be 10 minutes, once a day, 5 days per week for 2 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>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>Hamna Nasir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>25 Raza Saeed road, Bhabra block M Gulberg 3, Lahore, Punjab 25-Block Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 323 4500788</telephone>
        <email>wajeeha_z@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Wajeeha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>25 Raza Saeed road, Bhabra block M Gulberg 3, Lahore, Punjab 25-Block Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 323 4500788</telephone>
        <email>wajeeha_z@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age group of 35-55 years
Both male and female
At least history of COPD from 1 year
Decrease FEV1/FEV ratio
History of smoking</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute exacerbations of COPD
COPD diagnosed at severe stage
Patients with comorbidities
Patients with other life- threatening conditions
Patients who are vitally unstable</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J41</hc_code>
      <hc_code>J43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Simple and mucopurulent chronic bronchitis</hc_keyword>
      <hc_keyword>Emphysema</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: Diaphragmatic stretch with rib cage mobilization                                        Diaphragmatic Stretch Technique: The diaphragmatic stretch techniques will be applied on patient. Patient will be positioned in seated with your knees bent and feet flat on the floor. Place one hand on your chest, and the other on your belly. Take a deep breath in through your nose and focus on expanding your belly, allowing it to push out against your hand. Hold for a few seconds and then exhale slowly through your mouth, contracting your belly muscles as you do so. The treatment duration will be 10 minutes, once a day, 5 days per week for 2 weeks.                                                                                                                          Rib Cage Mobilization: Rib cage mobilization will be applied on patients in the seated position, the patients remained seated on the stretcher, keeping the feet on the floor, while the therapist stood in front of him or her. The patient’s head (frontal region) was positioned over his or her overlapping arms, which were placed on the therapist’s trunk. The therapist then positioned his or her fingertips at the costal angles (bilaterally), moving from the lateral region to the anterior midline throughout the patient’s inspiration and returning to the initial position on expiration. The therapist’s fingers were then placed 1 level below the rib, repeating this procedure until his or her fifth finger reached the 10th rib. This technique was then carried out toward the 1st rib, completing a treatment cycle. Another cycle was conducted after a 1-minute rest period. The treatment duration will be 20 minutes, once a day, 5 days per week for 2 weeks.</i_keyword>
      <i_keyword>Control group: Diaphragmatic stretch                                                                                     Diaphragmatic Stretch Technique: The diaphragmatic stretch techniques will be applied on patient. Patient will be positioned in seated with your knees bent and feet flat on the floor. Place one hand on your chest, and the other on your belly. Take a deep breath in through your nose and focus on expanding your belly, allowing it to push out against your hand. Hold for a few seconds and then exhale slowly through your mouth, contracting your belly muscles as you do so. The treatment duration will be 10 minutes, once a day, 5 days per week for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dyspnea. Timepoint: Pre-Post Treatment. Method of measurement: Modified Medical Research Council Dyspnea Scale (MMRC).</prim_outcome>
      <prim_outcome>Chest Expansion. Timepoint: Pre-Post Treatment. Method of measurement: Measuring Tape.</prim_outcome>
      <prim_outcome>Pulmonary Function Test. Timepoint: Pre-Post Treatment. Method of measurement: Portable 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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-14</approval_date>
        <contact_name>Riphah college of Rehabilitation &amp; Allied Health Sciences</contact_name>
        <contact_address>25 Raza Saeed road, Bhabra block M Gulberg 3, Lahore, Punjab 25-Block Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
