<?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>IRCT20210201050209N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-27</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Immediate effects of diaphragmatic breathing exercise versus pursed lip breathing exercise on blood pressure, pulse rate and oxygen saturation of patients with hypertension</public_title>
      <acronym></acronym>
      <scientific_title>Immediate effects of diaphragmatic breathing versus pursed lip breathing on blood pressure, pulse rate and oxygen saturation of patients with hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54074</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Non probability consecutive sampling will be used for recruiting people in study and simple random method (coin toss method) will be used for allocating sample in each group. Flipping of coin will be done at the time of group allocation to odd numbers of subjects such as if 1st person receives head of coin then 2nd person will receive tail of coin. At the time of 3rd person recruitment, coin will be flipped, then on the 5th person and so on, Blinding description: Only outcome assessor will be blinded. An outcome assessor will be called from other place and will collect pulse rate, blood pressure and oxygen saturation of patients before and after treatment without knowing about patient's groups so this study is single blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>people with raised blood pressure. Hypertension stage 1 and stage 2 are focused in this study.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Pursed Lip Breathing Exercise (PLBE). This is a breathing exercise. In this study, we will record the impact of pursed lip breathing exercise on blood pressure, oxygen saturation and pulse rate of patients with hypertension. There will be one group of 23 subjects with systolic bp of more than or equal to 140 mm Hg and diastolic bp of more than or equal to 90 mm Hg. Using Aneroid Sphygmomanometer bp will be taken before exercise and 5 minutes after exercise. Likewise, using pulse oximeter pulse rate and oxygen saturation will be taken before exercise and after 5 minutes of exercise. Procedure: One physiotherapist will guide the one group of patients to do PLBE by inhaling through the nose for two counts, keeping mouth closed in relaxed sitting position. Then the subjects will be asked to purse their lips, and breathe out (exhale) slowly and gently through pursed- lips while counting to four. The intervention will be applied for 3 to 4 times and then rest (for one minute), five sets will be applied in a treatment session. Assessor will be blinded only. Intervention 2: Intervention group2: Diaphragmatic Breathing Exercise (DBE). 2nd group with 23 subjects (male and females with 1:1 representation) with systolic bp of more than or equal to 140 mm Hg and diastolic bp of more than or equal to 90 mm Hg will be asked to perform diaphragmatic breathing exercise.  Using Aneroid Sphygmomanometer bp will be taken before exercise and 5 minutes after exercise. Likewise, using pulse oximeter pulse rate and oxygen saturation will be taken before exercise and after 5 minutes of exercise. Procedure: One physiotherapist will guide the one group of patients to do DBE. Procedure:  Patients will be asked to assume a relaxed position with back and head supported with full abdominal relaxation. Then they will be asked to breathe in slowly and deeply through the nose such as abdomen fills out, relax the shoulder and keep the upper chest quiet. Then the patient will be instructed to slowly let all the air out through the mouth and causing the abdomen to fall first. The intervention will be applied for 3 to 4 times and then rest (for one minute), five sets will be applied in a treatment session. Assessor will be blinded only.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Data for this study is being collected through community dwelling areas and there is no follow up for this study. Moreover, I have just taken the phone numbers of heads of institutes and not from the participants as participants were concerned about their privacy. They gave me consent only if I wont give their personal information to others.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yasha Sajjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>137 A block A Kahloon House, Nawab Town, Raiwind Road, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>53700</zip>
        <telephone>+92 42 36684109</telephone>
        <email>yashasajjad68@gmail.com</email>
        <affiliation>Nausha Polyclinic, Raiwind, Lahore District, Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasha Sajjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>137 A, Block A Kahloon House, Nawab Town, Raiwind Road, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>53700</zip>
        <telephone>+92 42 36684109</telephone>
        <email>yashasajjad68@gmail.com</email>
        <affiliation>Nausha Polyclinic, Raiwind</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with hypertension (stage 1 and stage 2) with Systolic Blood Pressure ≥ 140mmHg and Diastolic Blood Pressure ≥ 90 mmHg will be recruited.
40 to 60 years of age people will be inculded.
Both males and females will be recruited.
Patients who would have  taken any anti hypertensive medicines ( ACE inhibitors, calcium channel blockers, thiazide dieuretics, ACE receptor inhibitors, beta blockers) more than 6 hours ago or none will be included.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants who are unwilling to participate will not be recruited.
Patients who are critically terminally ill e.g. patients with mental illness, psychosocial factors, cancer, infectious diseases, and comatose patients will not be considered</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Pursed Lip Breathing Exercise (PLBE). This is a breathing exercise. In this study, we will record the impact of pursed lip breathing exercise on blood pressure, oxygen saturation and pulse rate of patients with hypertension. There will be one group of 23 subjects with systolic bp of more than or equal to 140 mm Hg and diastolic bp of more than or equal to 90 mm Hg. Using Aneroid Sphygmomanometer bp will be taken before exercise and 5 minutes after exercise. Likewise, using pulse oximeter pulse rate and oxygen saturation will be taken before exercise and after 5 minutes of exercise. Procedure: One physiotherapist will guide the one group of patients to do PLBE by inhaling through the nose for two counts, keeping mouth closed in relaxed sitting position. Then the subjects will be asked to purse their lips, and breathe out (exhale) slowly and gently through pursed- lips while counting to four. The intervention will be applied for 3 to 4 times and then rest (for one minute), five sets will be applied in a treatment session. Assessor will be blinded only.</i_keyword>
      <i_keyword>Intervention group2: Diaphragmatic Breathing Exercise (DBE). 2nd group with 23 subjects (male and females with 1:1 representation) with systolic bp of more than or equal to 140 mm Hg and diastolic bp of more than or equal to 90 mm Hg will be asked to perform diaphragmatic breathing exercise.  Using Aneroid Sphygmomanometer bp will be taken before exercise and 5 minutes after exercise. Likewise, using pulse oximeter pulse rate and oxygen saturation will be taken before exercise and after 5 minutes of exercise. Procedure: One physiotherapist will guide the one group of patients to do DBE. Procedure:  Patients will be asked to assume a relaxed position with back and head supported with full abdominal relaxation. Then they will be asked to breathe in slowly and deeply through the nose such as abdomen fills out, relax the shoulder and keep the upper chest quiet. Then the patient will be instructed to slowly let all the air out through the mouth and causing the abdomen to fall first. The intervention will be applied for 3 to 4 times and then rest (for one minute), five sets will be applied in a treatment session. Assessor will be blinded only.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Blood pressure will be recorded before and after 5 minutes of giving each intervention. Method of measurement: Blood Pressure will be recorded by using aneroid sphygmomanometer rate.</prim_outcome>
      <prim_outcome>Oxygen Saturation. Timepoint: Oxygen Saturation will be recorded before and after 5 minutes of giving each intervention. Method of measurement: oxygen saturation will be measured using pulse oximeter.</prim_outcome>
      <prim_outcome>Pulse Rate. Timepoint: Pulse rate will be recorded before and after 5 minutes of giving each intervention. Method of measurement: Pulse Rate will be recorded using pulse oximeter.</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>investigator initiated</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-23</approval_date>
        <contact_name>Riphah Research Ethical committee</contact_name>
        <contact_address>Madar e millat road, Quaid e azam industrial estate , Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
