<?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>IRCT20191123045478N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-30</date_registration>
      <primary_sponsor>Shiraz University</primary_sponsor>
      <public_title>The effects of Acute  High Intensity Interval and Isometric Handgrip training on high blood pressure</public_title>
      <acronym></acronym>
      <scientific_title>The effects of Acute  High Intensity Interval and Isometric Handgrip training on Some of hemodynamic Factors in Women With hypertention</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46046</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 group1 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 2 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>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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Salesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University, Eram Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71964-84334</zip>
        <telephone>+98 71 3613 4630</telephone>
        <email>mhsnsls@gmail.com</email>
        <affiliation>Shiraz University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Shakoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University  ,Eram Square</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
regularly menstruating
free of any chronic, cardiovascular, metabolic, renal or respiratory disease
No physical and functional limitations
non-smokers</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
pregnancy
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>N/A</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 group1 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 2 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>Systolic blood pressure. Timepoint: In eight times : before training, 0 (immediately after training), 5, 10, 15, 30, 45, 60 minutes after recovery period. Method of measurement: Digital sphygmomanometer.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: In eight times : before training, 0 (immediately after training), 5, 10, 15, 30, 45, 60 minutes after recovery period. Method of measurement: Digital sphygmomanometer.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: In eight times : before training, 0 (immediately after training), 5, 10, 15, 30, 45, 60 minutes after recovery period. Method of measurement: Digital sphygmomanometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: In eight times : before training, 0 (immediately after training), 5, 10, 15, 30, 45, 60 minutes after recovery period. Method of measurement: sphygmomanometer.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-27</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>
