<?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>IRCT20191123045478N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-16</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of 12 weeks of aerobic and resistance exercise on blood pressure</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 12 weeks of aerobic and resistance exercise on hemodynamic, biochemical and functional factors in women with hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52910</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Participants will be randomized into one of three groups (Two intervention and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope, Blinding description: In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Blood Pressure. Condition 2: Aerobic Exercise.</hc_freetext>
      <i_freetext>Intervention 1: Control group without exercise or Intervention: Participants in this group will have no exercise during the study. Intervention 2: Intervention group high intensity interval Aerobic training: Participants do aerobic exercise for one session . The duration of each session is 40 minutes, including pre-workout warm-up, aerobic exercise program, and post-workout cooling. Intervention 3: Intervention  group and isometric handgrip training: Participants do isometric handgrip exercise for one session . The duration of each session is 40 minutes, including pre-workout warm-up, aerobic exercise program, and post-workout cooling.</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:
The data can publish for publishing paper

When:
The study protocol will be available after publishing the paper

To whom:
everyone

Conditions:
For future studies

Where to obtain:
Via email

How to obtain:
The applicant needs to introduce his/her and need to explain the purpose of request as well. The information will send you as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Payman Izadpanah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sibooye Blvd, Al-Zahra Heart Hospital,</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71649-54937</zip>
        <telephone>+98 71 3739 8811</telephone>
        <email>paymanizadpanah@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Shakoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eram Square، Shiraz University</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71964-84334</zip>
        <telephone>+98 71 3613 4630</telephone>
        <email>eli_shakoor@yahoo.com</email>
        <affiliation>Shiraz University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>the Patient with high blood pressre (pre to stage 1 hypertension)
premenopausal
free of any chronic, cardiovascular, metabolic, renal or respiratory disease
No physical and functional limitations
non-smokers
Age between 33 to 55 years</inclusion_criteria>
      <agemin>33 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>use of any medications that may affect blood pressure and cardiovascular responses
regular exercise within the last six months
history of myocardial infarction and angioplasty
abnormalities of ECG, echo, and stress test</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R03</hc_code>
      <hc_code>Y93.A3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abnormal blood-pressure reading, without diagnosis</hc_keyword>
      <hc_keyword>Activity, aerobic and step exercise</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group without exercise or Intervention: Participants in this group will have no exercise during the study</i_keyword>
      <i_keyword>Intervention group high intensity interval Aerobic training: Participants do aerobic exercise for one session . The duration of each session is 40 minutes, including pre-workout warm-up, aerobic exercise program, and post-workout cooling.</i_keyword>
      <i_keyword>Intervention  group and isometric handgrip training: Participants do isometric handgrip exercise for one session . The duration of each session is 40 minutes, including pre-workout warm-up, aerobic exercise program, and post-workout cooling.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cortisol. Timepoint: Before and after intervention. Method of measurement: With ElISA kit.</prim_outcome>
      <prim_outcome>Nitric Oxide. Timepoint: Before and after intervention. Method of measurement: With ElISA kit.</prim_outcome>
      <prim_outcome>Endothelin-1. Timepoint: Before and after intervention. Method of measurement: With ElISA kit.</prim_outcome>
      <prim_outcome>Total Antioxidant Capacity. Timepoint: Before and after intervention. Method of measurement: With ElISA kit.</prim_outcome>
      <prim_outcome>Reactive oxygen species. Timepoint: Before and after intervention. Method of measurement: With ElISA kit.</prim_outcome>
      <prim_outcome>Peripheral Vascular Resistance. Timepoint: Before and after intervention. Method of measurement: with Doppler ultrasonography.</prim_outcome>
      <prim_outcome>Endothelial-dependent vasodilation. Timepoint: Before and after intervention. Method of measurement: with Doppler ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before and after intervention. Method of measurement: Digital Aneroid Sphygmomanometer Measure.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before and after intervention. Method of measurement: Digital Aneroid Sphygmomanometer Measure.</sec_outcome>
      <sec_outcome>Mean arterial pressure. Timepoint: Before and after intervention. Method of measurement: Digital Aneroid Sphygmomanometer Measure.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Before and after intervention. Method of measurement: Digital Aneroid Sphygmomanometer Measure.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-22</approval_date>
        <contact_name>Ethical Committee of Shiraz University of Medical Science</contact_name>
        <contact_address>5th Floor, Central building of Shiraz University of Medical Sciences, Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
