<?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>IRCT20160606028290N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-05</date_registration>
      <primary_sponsor>Shahid Beheshti Uni</primary_sponsor>
      <public_title>High intensity interval training and markers of blood fluidity in hypertensive patients</public_title>
      <acronym>HIIT</acronym>
      <scientific_title>Comparisons of two high intensity interval training protocols on markers of blood fluidity in hypertensive patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34785</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients referred to Shahid Rajayee Hospital who had the inclusion criteria were initially chosen and after the telephone contact and explanation of research agreed to participate. After measuring the  blood pressure all subjects were ordered from highest to lowest blood pressure were ordered and were allocated to the blocks of 3 (10 blocks). Thereafter, the 3 subjects in each block were randomly allocated to three groups (control, and 2 training groups), so that at the end there were 10 subjects in each group and the subjects with higher blood pressure were divided in 3 groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Pre-hypertension and hemorheological variables.</hc_freetext>
      <i_freetext>Intervention 1: Control group: No intervention received, only two blood samples were taken before and after training and were analyzed for hemorheological variables. Intervention 2: Intervention group: Short duration HIIT training                                                              After two weeks of continuous mild training, patients in SDHIIT group performed 8 weeks of HIIT included 27 min HIIT that encompassed 27 repetitions of 30s activity at 80%-100% of VO2peak interspersed by 30s passive/active (10%-20% of VO2peak) recovery. Two blood samples were taken before and after training and were analyzed for hemorheological variables. Intervention 3: Intervention group:  Long duration HIIT training                                                 Patients in LDHIIT group performed 8 weeks of HIIT (32min per session) included 4 repetitions of 4min activity at 75%-90% of VO2peak interspersed by 4min passive/active (15%-30% of VO2peak) recovery. Two blood samples were taken before and after training and were analyzed for hemorheological variables.</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 N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sajad Ahmadizad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University square, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2990 2931</telephone>
        <email>s_ahmadizad@sbu.ac.ir</email>
        <affiliation>Shahid Beheshti Uni</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sajad Ahmadizad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University square, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2990 2931</telephone>
        <email>s_ahmadizad@sbu.ac.ir</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>prehypertension
Blood pressure 130-150 mmHg
Age range between 40-60 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a regular exercise training</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>N/A</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: No intervention received, only two blood samples were taken before and after training and were analyzed for hemorheological variables.</i_keyword>
      <i_keyword>Intervention group: Short duration HIIT training                                                              After two weeks of continuous mild training, patients in SDHIIT group performed 8 weeks of HIIT included 27 min HIIT that encompassed 27 repetitions of 30s activity at 80%-100% of VO2peak interspersed by 30s passive/active (10%-20% of VO2peak) recovery. Two blood samples were taken before and after training and were analyzed for hemorheological variables.</i_keyword>
      <i_keyword>Intervention group:  Long duration HIIT training                                                 Patients in LDHIIT group performed 8 weeks of HIIT (32min per session) included 4 repetitions of 4min activity at 75%-90% of VO2peak interspersed by 4min passive/active (15%-30% of VO2peak) recovery. Two blood samples were taken before and after training and were analyzed for hemorheological variables.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood and plasma viscosity. Timepoint: Before training and 48 hours after the last training session. Method of measurement: EDTA Blood and using cone plate viscometer.</prim_outcome>
      <prim_outcome>RBC Aggregation. Timepoint: Before training and 48 hours after the last training session. Method of measurement: EDTA Blood and using Rheometer aggregometer.</prim_outcome>
      <prim_outcome>RBC deformability. Timepoint: Before training and 48 hours after the last training session. Method of measurement: EDTA Blood and using Rheometer aggregometer.</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>Shahid Beheshti Uni</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-21</approval_date>
        <contact_name>Shahid Rajaie cardiovascular center</contact_name>
        <contact_address>Cross section for Vali-asr st &amp; Hashemi Rafsanjani Hwy, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
