<?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>IRCT20220501054712N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effects of two types of resistance training on hypoxia-inducible factor-1 (HIF-1a), vascular endothelial growth factor, nitric oxide and endothelin-1.</public_title>
      <acronym>BFR</acronym>
      <scientific_title>Comparison of the effect of 8 weeks of resistance training with and without blood flow restriction on hypoxia-inducible factor-1 (HIF-1a), vascular endothelial growth factor, nitric oxide and endotelin-1 in men with prehypertension.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71906</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: A simple randomization method is used in this study. Randomization is run using random number tables. A table of random digits is a set of numbers that have been generated fully randomly without any pattern or specified order, and tabulated. 
First, an identifying number is assigned to each subject. This way, each person is identified by a number from 00 to 35. The researcher then randomly divides these numbers between three groups: intervention and control groups using a random digits table as follows. Upon the attendance of subjects, the researcher starts to read the numbers of the table. The subjects are assigned to the groups as follows: The first read identification number between 00 and 35 is assigned to the first intervention group (obstructive training group), the second number to the second intervention group (without obstructive training group), and the third number to the control group. This number assignment continues until 12 subjects are assigned to each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>primary hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: the high intensity resistance training without blood flow restriction for 8 weeks, 3 sessions per week with an intensity of 75% of one rep-max. Intervention 2: Intervention group 2: the low intensity resistance training with blood flow restriction for 8 weeks, 3 sessions per week with an intensity of 30% of one rep-max. Intervention 3: Intervention group 3: the low intensity resistance training without blood flow restriction for 8 weeks, 3 sessions per week with an intensity of 30% of one rep-max (control group).</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 The information has not been completed yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Yari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, Unit 17, Block 5, Milad Building, Daneshjoo Blvd.,</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>693994565</zip>
        <telephone>+98 918 343 6046</telephone>
        <email>Aliyari9090@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Yari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, Unit 17, Block 5, Milad Building, Daneshjoo Blvd.,</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931994565</zip>
        <telephone>+98 918 343 6046</telephone>
        <email>Aliyari9090@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men with prehypertension
Physical and mental health
Having no history of regular sport activity during the previous two years
Informed personal consent to participate in the study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having no cardiovascular diseases
Having no oncological diseases
Having no hormonal diseases
Having no acute or chronic diseases
Not being addicted to drugs and cigarettes
No medication intake</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>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: the high intensity resistance training without blood flow restriction for 8 weeks, 3 sessions per week with an intensity of 75% of one rep-max.</i_keyword>
      <i_keyword>Intervention group 2: the low intensity resistance training with blood flow restriction for 8 weeks, 3 sessions per week with an intensity of 30% of one rep-max.</i_keyword>
      <i_keyword>Intervention group 3: the low intensity resistance training without blood flow restriction for 8 weeks, 3 sessions per week with an intensity of 30% of one rep-max (control group).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hypoxia-inducible factor-1 (HIF-1a). Timepoint: The tests will be done in two stages: one day before the first training session (pre-test) and 48 hours after the last training session (post-test),  on the 8th week of training and after 10-12 hours of fasting. Method of measurement: After samples coagulation and serum centrifugation, the serum levels of variables are determined using the ELISA method.</prim_outcome>
      <prim_outcome>Vascular endothelial growth factor. Timepoint: The tests will be done in two stages: one day before the first training session (pre-test) and 48 hours after the last training session (post-test),  on the 8th week of training and after 10-12 hours of fasting. Method of measurement: After samples coagulation and serum centrifugation, the serum levels of variables are determined using the ELISA method.</prim_outcome>
      <prim_outcome>Nitric oxide. Timepoint: The tests will be done in two stages: one day before the first training session (pre-test) and 48 hours after the last training session (post-test),  on the 8th week of training and after 10-12 hours of fasting. Method of measurement: After samples coagulation and serum centrifugation, the serum levels of variables are determined using the ELISA method.</prim_outcome>
      <prim_outcome>Endotelin-1. Timepoint: The tests will be done in two stages: one day before the first training session (pre-test) and 48 hours after the last training session (post-test),  on the 8th week of training and after 10-12 hours of fasting. Method of measurement: After samples coagulation and serum centrifugation, the serum levels of variables are determined using the ELISA method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: two months. Method of measurement: Measurements will be done in two stages: one day before the first training session (pre-test) and 48 hours after the last training session (post-test), on the 8th week of training using pressure gauge device.</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>2023-07-19</approval_date>
        <contact_name>Islamic Azad University Kermanshah Branch</contact_name>
        <contact_address>Farhikhtegan Blvd., Ferdowsi Sq., Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
