<?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>IRCT20201024049129N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-18</date_registration>
      <primary_sponsor>Riphah International university</primary_sponsor>
      <public_title>Effect of diaphragmatic breathing exercise  on heart rate and blood pressure</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of diaphragmatic breathing exercise and active cycle of breathing technique on heart rate and blood pressure in patients with hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54784</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group by simple lottery method. Odd and even numbers will be given to group A and B respectively. if a patient gets odd no he/she will be allocated in Group A. If a patient gets Even number he/she will be allocated in Group B. Total sample size will be 40. So, 20 patients will get even number and 20 will get odd number, Blinding description: Participants will be blinded in terms of group allocation.  Written Consent will be  taken from patients but they will not be informed about the group in which  they will be treated and the effects of treatment in each groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Diaphragmatic Breathing Exercise : Patiemt will be in semi fowler position. Therapist will place one hand on rectus abdominis below anterior costal.margin. After patient understand and is able to breath using diaphragmatic pattern,suggest the patient to breath nose and through mouth. Control expiration for 4 or 5 times per session. Each session will  be given for 7 days per week (4 weeks). Intervention 2: Intervention group 2: Active cycle of breathing technique: This technique involves 3 parts. Breathing control in which patient will breath out gently and will be 3 to 5 deeper breaths with 2 second hold at the end of breath in before breath out. Second part  is thoracic expansion exn exercise in which patient will keep hia shoulder and chest relaxed and will take a long slow deep breath in through nose. Patient will hold air in lungs for 2-3 seconds before breathing out. And the 3rd part huffing exhaling through open mouth . The session will last for 15 minutes for 7 days per week(4weeks).</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>Khazima Asif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganj shaker colony Alama anwar ul hasan road near swat agro chemical sahiwal</address>
        <city>Sahiwal</city>
        <country1>Pakistan</country1>
        <zip>57000</zip>
        <telephone>+92 334 4886859</telephone>
        <email>khazimaasif73@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Wajeeha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>47 Tufail road cantt 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>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with age range 45-65 years
Patients clinically diagnosed with hypertension
Patients who will give consent to abide by treatment for 4 weeks.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of precious surgery
History of rib fracture
Any neurological problem
Patients with respiratory disease
Patients with coronary artery disease
Pregnant females</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>RO3.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Diaphragmatic Breathing Exercise : Patiemt will be in semi fowler position. Therapist will place one hand on rectus abdominis below anterior costal.margin. After patient understand and is able to breath using diaphragmatic pattern,suggest the patient to breath nose and through mouth. Control expiration for 4 or 5 times per session. Each session will  be given for 7 days per week (4 weeks).</i_keyword>
      <i_keyword>Intervention group 2: Active cycle of breathing technique: This technique involves 3 parts. Breathing control in which patient will breath out gently and will be 3 to 5 deeper breaths with 2 second hold at the end of breath in before breath out. Second part  is thoracic expansion exn exercise in which patient will keep hia shoulder and chest relaxed and will take a long slow deep breath in through nose. Patient will hold air in lungs for 2-3 seconds before breathing out. And the 3rd part huffing exhaling through open mouth . The session will last for 15 minutes for 7 days per week(4weeks).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic and Diastolic Blood Pressure. Timepoint: Pre Intervention and  Post Intervention  for all 4 weeks. Method of measurement: Mercury Spygmomanometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: Pre intervention and post intervention at the end of each day for 4 weeks. Method of measurement: By pulse oximeter in minutes.</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>2021-01-04</approval_date>
        <contact_name>Name of ethics commitee: Riphah college of rehabilitation and Allied Health Sciences.</contact_name>
        <contact_address>13-14-C civic center, township near Hamdard Chowk, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
