<?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>IRCT20200815048410N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-18</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Evaluation of the effect of aerobic exercise in patients with hypertension</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 12 weeks of aerobic exercise on a selection of symptoms of heart failure in women patients with hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50336</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: According to a call, people with high blood pressure who live in Abdanan will be invited to participate in the study. Then, from among the volunteers, 35 people will be purposefully selected based on the inclusion criteria. Then the names of all the subjects were written on the cards and placed in a bag. Then, the cards were taken out by lottery and the person in question was placed in the intervention and control groups, respectively. After reading the card, the card was returned to the bag.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Women with hypertension with an age range of 50 to 70 years, according to the seventh report of the Joint National Committee for the Prevention, Diagnosis, Measurement and Treatment of Hypertension, in stage 1 hypertension (systolic pressure 159-140 and diastolic pressure 99-90 mm Mercury).</hc_freetext>
      <i_freetext>Intervention 1: The training program consisted of 12 weeks of aerobic exercise with an intensity of 30 to 60% of the maximum heart rate, 45 minutes per session and 3 sessions per week. Intervention 2: Control group: The control group did not participate in any training program.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data studied can be shared after unidentified individuals.

When:
Access information after printing results

To whom:
Available to researchers working in academic and scientific institutions.

Conditions:
The conditions for sending documents to the applicant will be explained.

Where to obtain:
Email to the following address
s.abedzadeh89@gmail.com

How to obtain:
The applicant's request will be answered by the research team after review.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Aabedzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Shahid Darabi Alley, 15 Khordad North St</address>
        <city>Abdanan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6971753469</zip>
        <telephone>+98 84 3362 4252</telephone>
        <email>s.abedzade89@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Abedzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Shahid Darabi Alley, 15 Khordad North St</address>
        <city>Abdanan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6971753469</zip>
        <telephone>+98 84 3362 4252</telephone>
        <email>s.abedzade89@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>They were between 50 and 70 years old.
They had high blood pressure
They had no history of heart or balloon surgery
Not diabetic
Non-athletes
All subjects are in menopause</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exercise 6 months before the research
Cardiovascular diseases
Use of non-hypertensive drugs
Unseen 3 more sessions during the investigation</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The training program consisted of 12 weeks of aerobic exercise with an intensity of 30 to 60% of the maximum heart rate, 45 minutes per session and 3 sessions per week..</i_keyword>
      <i_keyword>Control group: The control group did not participate in any training program</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>NT-proBNP concentration. Timepoint: 24 hours before the start of aerobic exercise and 24 hours after 12 weeks of exercise. Method of measurement: ELISA kit made by the Chinese company Casabio to measure the amount of N-terminal pro – B-type natriuretic peptide (NT-proBNP).</prim_outcome>
      <prim_outcome>CT-1 concentration. Timepoint: 24 hours before the start of aerobic exercise and 24 hours after 12 weeks of exercise. Method of measurement: ELISA kit made by the Chinese company Casabio to measure the amount Cardiotropin-1 ( CT-1).</prim_outcome>
      <prim_outcome>TGF-β1 concentration. Timepoint: 24 hours before the start of aerobic exercise and 24 hours after 12 weeks of exercise. Method of measurement: ELISA kit made by the Chinese company Casabio to measure the amount Transforming growth factor beta 1(TGF-β1).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before and after each workout. Method of measurement: Digital sphygmomanometer in millimeters of mercury.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before and after each workout. Method of measurement: Digital sphygmomanometer in millimeters of mercury.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-01</approval_date>
        <contact_name>Sport Sciences Research Institute</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
