<?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>IRCT20191117045462N24</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-29</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Comparative Effect of Buteyko Breathing Technique and Lotorp Method Among COPD</public_title>
      <acronym>Effects of Lotorp Method Among COPD.</acronym>
      <scientific_title>Comparative Effect of Buteyko Breathing Technique and Lotorp Method Among COPD</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78003</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 study will be double blinded. 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 Pulmonary Obstructive Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: Buteyko breathing technique:   Treatment to this  groups will be performed  twice a day, 3-5 times per week, for 3-4 months. . The idea behind it is that people tend to hyperventilate –to breathe faster and more deeply than necessary. Subjects in the Buteyko a groups were trained for 3–5 days and instructed to practice the exercises for 15 minutes twice daily, and for three months duration.                                                                                                       Step 1: The ‘‘Control pause (CP)’’ breathing test                                                           Step 2: Shallow breathing Sit up straight                                                                     Step 3: Putting it together Take Control pause                                                              Each patient was trained by Buteyko breathing technique twice per week, and the session was about (20 min).                                                                                         The first week each patient of this group trained by Buteyko breathing technique intensively for 4 days then the following 3 weeks were 2 sessions per week. The time of the session was in the morning at least two hours after meals. Each patient performed the BBT by himself at home twice daily (in the morning and in the evening, at least 2 h after meals) during the time of the study Buteyko Breathing Technique. Intervention 2: Intervention group B : Lotorp Method:                                                                 Lotorp Method is a two-part therapy involving daily breathing exercises and massage of thoracic muscles at the clinic every third week. The treatment at the clinic is performed for a time of about 60 min. It starts massage based on classic Swedish massage, combined with trigger point treatment if the therapist finds specially tense points in the muscles. On the larger muscles are performed a little faster rubbing movement. The patient lies on his/ her stomach when the back is treated. Back muscles and tendons treated with deep massage are: Erector şpinae, (the sacro spinal system),Rhomboids major and minor, Quadratus lumborum, and external intercostal muscles, Sternum (several muscles attach to the sternum, and a rubbing movement is used to stimulate these attachments),Subclavius, Serratus anterior (upper parts), Scalene Sternocleidomastoids, Diaphragm (external front part), abdominal muscles (transverses abdominis, oblique, internusabdominis, externus abdominis and rectus abdominis). After this exhalations are manually assisted during exhalation by pressing the chest, slowly but powerfully. The hands are placed along the side of the chest and deep exhalations are performed 10 times. Then the hands are moved to the upper parts of the chest. A similar manual pressure during exhalation is performed 5 times. After this the patient is instructed to breathe in and out so that the thorax is moving as much as possible. Treatment to this  groups will be performed  twice a day, 3-5 times per week, for 3-4 months.</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>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients between age group of 40-65 years
Patients of both genders.
Patients with mild or moderate COPD according to the GOLD criteria</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with restrictive lung disease.
Patients with any infection.
Patients having uncontrolled asthma.
Pregnant women
Risk of pneumothorax
Low resting oxygen saturation
unstable conditions, active infections and neurological condition
Patients who cannot comply this technique</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Chronic br</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>J44.8</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: Buteyko breathing technique:   Treatment to this  groups will be performed  twice a day, 3-5 times per week, for 3-4 months. . The idea behind it is that people tend to hyperventilate –to breathe faster and more deeply than necessary. Subjects in the Buteyko a groups were trained for 3–5 days and instructed to practice the exercises for 15 minutes twice daily, and for three months duration.                                                                                                       Step 1: The ‘‘Control pause (CP)’’ breathing test                                                           Step 2: Shallow breathing Sit up straight                                                                     Step 3: Putting it together Take Control pause                                                              Each patient was trained by Buteyko breathing technique twice per week, and the session was about (20 min).                                                                                         The first week each patient of this group trained by Buteyko breathing technique intensively for 4 days then the following 3 weeks were 2 sessions per week. The time of the session was in the morning at least two hours after meals. Each patient performed the BBT by himself at home twice daily (in the morning and in the evening, at least 2 h after meals) during the time of the study Buteyko Breathing Technique.</i_keyword>
      <i_keyword>Intervention group B : Lotorp Method:                                                                 Lotorp Method is a two-part therapy involving daily breathing exercises and massage of thoracic muscles at the clinic every third week. The treatment at the clinic is performed for a time of about 60 min. It starts massage based on classic Swedish massage, combined with trigger point treatment if the therapist finds specially tense points in the muscles. On the larger muscles are performed a little faster rubbing movement. The patient lies on his/ her stomach when the back is treated. Back muscles and tendons treated with deep massage are: Erector şpinae, (the sacro spinal system),Rhomboids major and minor, Quadratus lumborum, and external intercostal muscles, Sternum (several muscles attach to the sternum, and a rubbing movement is used to stimulate these attachments),Subclavius, Serratus anterior (upper parts), Scalene Sternocleidomastoids, Diaphragm (external front part), abdominal muscles (transverses abdominis, oblique, internusabdominis, externus abdominis and rectus abdominis). After this exhalations are manually assisted during exhalation by pressing the chest, slowly but powerfully. The hands are placed along the side of the chest and deep exhalations are performed 10 times. Then the hands are moved to the upper parts of the chest. A similar manual pressure during exhalation is performed 5 times. After this the patient is instructed to breathe in and out so that the thorax is moving as much as possible. Treatment to this  groups will be performed  twice a day, 3-5 times per week, for 3-4 months.</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>Disease Specific. Timepoint: Pre- Post Treatment. Method of measurement: St Georges Respiratory Questionnaire (SGRQ).</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 Lahore</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>
