<?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>IRCT20191117045462N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-31</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Effects Of Dynamic Hug Exercise And Serratus Punch On Chest Wall Mobility, Dyspnea, Pulmonary Function Test And Strength Of Scapulothoracic Muscle In COPD</public_title>
      <acronym></acronym>
      <scientific_title>Effects Of Dynamic Hug Exercise And Serratus Punch On Chest Wall Mobility, Dyspnea, Pulmonary Function Test And Strength Of Scapulothoracic Muscle In COPD</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77898</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who will meet the inclusion criteria will be recruited by convenient sampling technique and allocated to groups by simple randomization process using sealed opaque enveloped labeled as 0 for Group A and for 1 group B, Blinding description: This is single blinded study. Although the patient will sign a consent form but still he will not be aware of other treatment group. Another physical therapist or assessor will be involved in the study. He/she must have a minimum of 2 years of clinical experience in the relevant domain. He will assess the patient by defined outcome measure tools before start, follow up and, at the end of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COPD.</hc_freetext>
      <i_freetext>Intervention 1: Control group: it will be treated by pursed lip breathing (to inhale through the nose for several seconds with the mouth closed and then exhale slowly over 4 to 6 seconds through lips held in a whistling or kissing position. This cycle can be repeated for three to five breaths per session), upper trapezius stretching (Moderate stretching Hold stretch 60 sec. /time 5 times/set, 1 set/day 3 days/weeks, 8 weeks). Intervention 2: Intervention group: it will be treated by pursed lip breathing, upper trapezius stretching as well as dynamic hug (The subject will stand with the feet shoulder-width apart, elbows flexed at 90° and internally rotated at 90°, and shoulders abducted at 90°. The subject will push the handle using horizontal shoulder adduction and elbow extension until the hands touch together) and serratus punch (The patient will lie down on the floor. Then he will Raise both arms directly above shoulders and keep the elbows straight. Proceed to protract the shoulder blades by pushing them forwards (pushing the fists towards the ceiling)).</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>Kazmah Azeem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>H # 21 St# 103 Ghazi Park New Shad Bagh Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>05475</zip>
        <telephone>+92 309 9071269</telephone>
        <email>qazam6942@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Wajeeha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13-14-C-civic center, township near Hamdard Chowk, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>05475</zip>
        <telephone>+92 42 35126110</telephone>
        <email>wajeeha_z@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Stable mild to moderate COPD according to GOLD guidelines
40-60 years of age will be included.
Stable hemodynamics (heart rate, blood pressure, temperature)
FEV1≥50</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Subjects having any kind of Infective pulmonary conditions.
The subjects with acute exacerbation.
Uncontrolled hypertension
Fracture at the clavicle, scapula, humerus, sternum or spine within previous 2 months
Patients with any diagnosed neurological, orthopedic and cardiovascular disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified chronic obstructive pulmonary disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: it will be treated by pursed lip breathing (to inhale through the nose for several seconds with the mouth closed and then exhale slowly over 4 to 6 seconds through lips held in a whistling or kissing position. This cycle can be repeated for three to five breaths per session), upper trapezius stretching (Moderate stretching Hold stretch 60 sec. /time 5 times/set, 1 set/day 3 days/weeks, 8 weeks)</i_keyword>
      <i_keyword>Intervention group: it will be treated by pursed lip breathing, upper trapezius stretching as well as dynamic hug (The subject will stand with the feet shoulder-width apart, elbows flexed at 90° and internally rotated at 90°, and shoulders abducted at 90°. The subject will push the handle using horizontal shoulder adduction and elbow extension until the hands touch together) and serratus punch (The patient will lie down on the floor. Then he will Raise both arms directly above shoulders and keep the elbows straight. Proceed to protract the shoulder blades by pushing them forwards (pushing the fists towards the ceiling)).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dyspnea. Timepoint: pre post treatment. Method of measurement: Medical Research Council (MRC) Dyspnea Scale.</prim_outcome>
      <prim_outcome>Pulmonary function test. Timepoint: pre, post treatment. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>Chest wall expansion. Timepoint: pre, post treatment. Method of measurement: inches tape.</prim_outcome>
      <prim_outcome>Scapulothoracic muscle strength. Timepoint: pre, post treatment. Method of measurement: Handheld dynamometer.</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>
