<?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>IRCT20191117045462N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-24</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Effects of Pilates breathing versus Rhythmic Initiation Proprioceptive neuromuscular facilitation technique in Chronic Obstructive Pulmonary Disease (COPD) patients</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Pilates breathing versus Rhythmic Initiation Proprioceptive neuromuscular facilitation technique in Chronic Obstructive Pulmonary Disease (COPD) patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73247</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 envelope system as mentioned below
1- Fifty- two sealed envelopes were randomly given to participating clinicians (in shuffled form) with half having treatment A and half having treatment B in them.
2- After taking consent from the patient, the clinician randomly picks up an envelope and allocates the patient to the treatment regimen mentioned in the envelope, Blinding description: Both participants and outcome assessor will be blind. assessment will be done by second therapist who will not be involved in treatment and data analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Chronic Bronchitis. Condition 2: Emphysema.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Conventional Pulmonary Rehabilitation with Pilates breathing. The Conventional treatment includes Pursed lip breathing, Diaphragmatic Breathing and Postural drainage. Intervention 2: Intervention group: Conventional Pulmonary Treatment with Rhythmic Initiation PNF technique. The Conventional treatment includes Pursed lip breathing, Diaphragmatic Breathing and Postural drainage.</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>Mishal Fatim</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 35-65years
Both male and females
Chronic Obstructive Pulmonary Disease (COPD) diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines at mild stage.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with any recent surgery
Patients with other medical conditions that may interfere with exercise program
Patients doing yoga training• Diagnosis of other chronic lung disease such as (bronchiectasis, cystic fibrosis, asthma ,interstitial lung disease, lung cancer)
Mental Illness</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:  Conventional Pulmonary Rehabilitation with Pilates breathing. The Conventional treatment includes Pursed lip breathing, Diaphragmatic Breathing and Postural drainage.</i_keyword>
      <i_keyword>Intervention group: Conventional Pulmonary Treatment with Rhythmic Initiation PNF technique. The Conventional treatment includes Pursed lip breathing, Diaphragmatic Breathing and Postural drainage.</i_keyword>
    </intervention_keyword>
    <primary_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>Pulmonary Function Tests. 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>
