<?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>IRCT20220930056062N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-10</date_registration>
      <primary_sponsor>Government College University Faisalabad</primary_sponsor>
      <public_title>Upper limb resistance  exercises for COPD patients</public_title>
      <acronym></acronym>
      <scientific_title>Effects of upper limb resistance  exercises on Aerobic capacity, Strength and Quality of life (QOL) in COPD patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77268</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Randomization through lottery method. Each participant will be asked to choose between two pieces of paper labeled "Group A" and "Group B." They will be assigned to treatment groups based on the paper they select, Blinding description: Patients will be blind in this clinical trial. 
In this single-blinded RCT study, participants will be unaware of which treatment they are receiving. To ensure blinding, the treatments will be somewhat similar. The allocation sequence will be concealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic obstructive pulmonary disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Aerobic exercise and inspiratory muscle training will be performed for 5-15 minutes, involving three sets with 10 repititions and a rest interval of 1-2 minute with threshold strength instruments, with additional upper limb resistance exercise in three sets with 10 repititions with rest interval of 1-2 minutes between each sets which will be followed by message therapy. Intervention 2: Control group: The control group will warm-up with slow walking, deep breathing and arm circles for 5-15 minutes. Aerobic exercise and inspiratory muscle training will be performed for 5-15 minutes, involving three sets with 10 repetitions and a rest interval of 1-2 minute with threshold strength instruments. At the end of session stretching will be performed for 5-10 minutes.</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 No - There is not a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rafia Imtiaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 9200876</telephone>
        <email>rafiaimtiaz@gcuf.edu.pk</email>
        <affiliation>Government College University Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rafia Imtiaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 9200886</telephone>
        <email>rafiaimtiaz@gcuf.edu.pk</email>
        <affiliation>Government College University Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of patients taken is 25-55 years
Patients of  both genders
Individuals with stable COPD(Chronic bronchitis, Emphysema, asthma) being monitored by pulmonologist</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>MSK  (frozen shoulder, osteoarthritis, rheumatoid arthritis, , traumatic fractures, amputation)•	Cardiac (Angina pectoris, recent MI, severe pulmonary hypertension, CHF, Unstable diabetes, Severe exercise-induced hypoxemia)	•	.
Surgery (Thoracic surgery, CABG)
Cognitively impaired dementia
Peripheral oxygen saturation &lt;90% during 6 min. walk test</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other 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>Intervention group: Aerobic exercise and inspiratory muscle training will be performed for 5-15 minutes, involving three sets with 10 repititions and a rest interval of 1-2 minute with threshold strength instruments, with additional upper limb resistance exercise in three sets with 10 repititions with rest interval of 1-2 minutes between each sets which will be followed by message therapy</i_keyword>
      <i_keyword>Control group: The control group will warm-up with slow walking, deep breathing and arm circles for 5-15 minutes. Aerobic exercise and inspiratory muscle training will be performed for 5-15 minutes, involving three sets with 10 repetitions and a rest interval of 1-2 minute with threshold strength instruments. At the end of session stretching will be performed for 5-10 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Exertion. Timepoint: Assessment will be made two time before and after 4 weeks. Method of measurement: Modified Borg Scale.</prim_outcome>
      <prim_outcome>6 min. walk test. Timepoint: Assessment will be made two time before and after 4 weeks. Method of measurement: 6 min. walk test.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Assessment will be made two time before and after 4 weeks. Method of measurement: St. George’s Respiratory Questionnaire.</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>It is a self funded study. All financial expenses are bear personally</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-25</approval_date>
        <contact_name>Government College University Faisalabad</contact_name>
        <contact_address>Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
