<?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>IRCT20191117045462N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-23</date_registration>
      <primary_sponsor>Riphah international university</primary_sponsor>
      <public_title>combined effects of diaphragmatic breathing and Thoracic Kinesio Taping on Pulmonary functions, dyspnea,thoracoabdominal mobility and quality of life in Chronic Obstructive Pulmonary Disease</public_title>
      <acronym></acronym>
      <scientific_title>combined effects of diaphragmatic breathing and thoracic kinesio taping on pulmonary functions, dyspnea, thoracoabdominal mobility and quality of life in Chronic obstructive Pulmonary Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78021</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Taking into account the aforementioned inclusion and exclusion criteria patients will be divided into two groups by convenient sampling and allocated to 2 groups by simple randomization process by sealed opaque envelope method and labeled as 0 for group A and 1 for group B, Blinding description: Investigator will be blind.Assesment will be done by 2nd therapist who will not be involved in treatment and data analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mild to moderate COPD patients.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group will receive thoracic kinesio taping and diaphragmatic breathing exercises.Diaphragmatic breathing exercises will be performed by  assuming flat position. Be sure to flex your knees and support your head.• Put one hand over your breastbone in the center of your chest, and the other just below your rib.Take a calm, deep breath in through your nose.• Squeeze out with your lips pursed and tense the muscles directly beneath your ribs.• Advice: Tighten your muscles while using the hand you placed below your ribs to gently push in and up. • Participant will be scheduled to attend 20 treatment sessions (5 sessions every week for 4 weeks,35 minutes each session)Assessment will be done on 0 weeks, 2nd week, and 4th week• Thoracic Kinesio Taping will be performed by this process :The material to be used for thoracic KT application will be 100% cotton, latex-free, 5-cm wide, elastic tape. Patients will be instructed to sit upright on an armless chair with no back support, with knees flexed to 90 degrees, feet on the floor and arms relaxed. Kinesio tape will be applied anteriorly and posteriorly to facilitate respiratory muscles (primarily diaphragm) along the subcostal area. Anteriorly, the base point of an “I” shaped kinesio tape will be applied on xiphoid process with 50-75% tension only on the linea alba and the tails of the tape will be applied towards subcostal curvature with no tension. Posteriorly, a second “I” shaped kinesio tape will be applied from the back. The base point of the tape will be applied on the projection of 12th Thoracic vertebra with 50-75% tension and the tails will be applied toward the ribs without any tension. Additionally, two more kinesio tapes will be applied to upper trapezius area which lies between neck and acromion at both sides (left and right).• Patient will be taped for about 48 hours• Participant will be scheduled to attend 12 treatment sessions (3 sessions every week for 4 weeks, 35mints each session)• Assessment will be done on 0-week, 2nd week, and 4th week. Treatment evaluation will be done by measuring severity of dyspnea by dyspnea-12 scale,quality of life will be measured by st. george questionnaire and pulmonary function by spirometry. Intervention 2: Control group: will receive diaphragmatic breathing exercises.Diaphragmatic breathing exercises will be performed by  assuming flat position. Be sure to flex your knees and support your head.• Put one hand over your breastbone in the center of your chest, and the other just below your rib.Take a calm, deep breath in through your nose.• Squeeze out with your lips pursed and tense the muscles directly beneath your ribs.• Advice: Tighten your muscles while using the hand you placed below your ribs to gently push in and up. • Participant will be scheduled to attend 20 treatment sessions (5 sessions every week for 4 weeks,35 minutes each session)Assessment will be done on 0 weeks, 2nd week, and 4th week• Treatment evaluation will be done by measuring severity of dyspnea by dyspnea-12 scale,quality of life will be measured by st. george questionnaire and pulmonary function by spirometry.</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>Arfa Amin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>803000720844</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 Rd, Bhabra Block M Gulberg III, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35126102</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>Mild to moderate level COPD patients
Both male and female gender
Age between 40-60 years
Vitally stable patient
Individuals with no prior experience with thoracic Kinesio taping</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants with unstable medical conditions (e.g., cardiovascular instability)
Individuals with cognitive impairments
Pregnant women
Participants with known allergies to tape
Participants with known respiratory conditions other than COPD
Diabetic patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental group will receive thoracic kinesio taping and diaphragmatic breathing exercises.Diaphragmatic breathing exercises will be performed by  assuming flat position. Be sure to flex your knees and support your head.• Put one hand over your breastbone in the center of your chest, and the other just below your rib.Take a calm, deep breath in through your nose.• Squeeze out with your lips pursed and tense the muscles directly beneath your ribs.• Advice: Tighten your muscles while using the hand you placed below your ribs to gently push in and up. • Participant will be scheduled to attend 20 treatment sessions (5 sessions every week for 4 weeks,35 minutes each session)Assessment will be done on 0 weeks, 2nd week, and 4th week• Thoracic Kinesio Taping will be performed by this process :The material to be used for thoracic KT application will be 100% cotton, latex-free, 5-cm wide, elastic tape. Patients will be instructed to sit upright on an armless chair with no back support, with knees flexed to 90 degrees, feet on the floor and arms relaxed. Kinesio tape will be applied anteriorly and posteriorly to facilitate respiratory muscles (primarily diaphragm) along the subcostal area. Anteriorly, the base point of an “I” shaped kinesio tape will be applied on xiphoid process with 50-75% tension only on the linea alba and the tails of the tape will be applied towards subcostal curvature with no tension. Posteriorly, a second “I” shaped kinesio tape will be applied from the back. The base point of the tape will be applied on the projection of 12th Thoracic vertebra with 50-75% tension and the tails will be applied toward the ribs without any tension. Additionally, two more kinesio tapes will be applied to upper trapezius area which lies between neck and acromion at both sides (left and right).• Patient will be taped for about 48 hours• Participant will be scheduled to attend 12 treatment sessions (3 sessions every week for 4 weeks, 35mints each session)• Assessment will be done on 0-week, 2nd week, and 4th week. Treatment evaluation will be done by measuring severity of dyspnea by dyspnea-12 scale,quality of life will be measured by st. george questionnaire and pulmonary function by spirometry.</i_keyword>
      <i_keyword>Control group: will receive diaphragmatic breathing exercises.Diaphragmatic breathing exercises will be performed by  assuming flat position. Be sure to flex your knees and support your head.• Put one hand over your breastbone in the center of your chest, and the other just below your rib.Take a calm, deep breath in through your nose.• Squeeze out with your lips pursed and tense the muscles directly beneath your ribs.• Advice: Tighten your muscles while using the hand you placed below your ribs to gently push in and up. • Participant will be scheduled to attend 20 treatment sessions (5 sessions every week for 4 weeks,35 minutes each session)Assessment will be done on 0 weeks, 2nd week, and 4th week• Treatment evaluation will be done by measuring severity of dyspnea by dyspnea-12 scale,quality of life will be measured by st. george questionnaire and pulmonary function by spirometry.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dyspnea. Timepoint: Pre post treatment. Method of measurement: Dyspnea 12 Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pulmonary functions. Timepoint: Pre post treatment. Method of measurement: Digital Spirometer.</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>2024-01-15</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 Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
