<?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>IRCT20221120056548N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-30</date_registration>
      <primary_sponsor>Danesh Alborz University</primary_sponsor>
      <public_title>Effect of exercise, chitosan and spirulina on high blood pressure</public_title>
      <acronym></acronym>
      <scientific_title>The effect of spirulina and chitosan supplementation along with eight weeks of combined exercises on blood pressure and lipid profile in hypertensive women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66983</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this randomization, the method of equal blocks (10 blocks of 4) has been used, in which a number of intervention people and a number of comparison people are included in each block, and we have allocated them to different groups. The method and tool of block random sequence generation has been done using https://www.sealedenvelope.com/simple-randomiser/v1/lists.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertensive diseases.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: The exercise intervention in this research will be 8 weeks of combined aerobic and resistance exercises. 3 days a week (Saturday-Monday-Wednesday) from 5 to 6 in the evening by the subject. Aerobic training includes 30 minutes of non-stop walking from the first to the fourth week with an intensity of 40% of the maximum heart rate (MHR) 1 and from the fourth to the eighth week of the study with an intensity of 60% of the maximum heart rate (MHR), then warming up between the two exercises 10 repetitions of a movement and after 5 minutes 1RM2 test will be done and then resistance exercises will be done. Resistance exercises will be 30 minutes in the first 4 weeks with 40% intensity of a maximum repetition ("using 2 or 3 kg dumbbells and elastic resistance bands with yellow color (low intensity) of the brand ("RACINESS") and in the second 4 weeks with an intensity of 60% one maximum repetition ("using 4 or 5 kg dumbbells and resistance bands with blue color (medium intensity) brand RACINESS" ) are performed in 3 sets with 12 repetitions and 90 seconds rest between each set and 120 seconds between each exercise. Resistance exercises include horizontal leg press - rowing from the bottom (Low Row) - exercises Sitting with a chair (extensor chair) is a bench press exercise (chest and head). The supplement group also consumes 4.5 grams of spirulina supplement daily eensea.ir (provided by Danish Gulf Algae Technology Development Company), will be consumed by subjects in the form of 7 capsules of 600 mg per day. Chitosan supplement in the amount of 2 capsules in the specified dose of Karen company, each 500 mg before meals, is used by the subjects in the designated 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
It will be available for researchers working in academic and scientific institutions.

Conditions:
If the intellectual rights are preserved, the data can be sent to the researchers.

Where to obtain:
Email address:saeidshamlou9092@gmail.com

How to obtain:
Submission of a written request (one week)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeid Shamlou Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdiyeh Ave</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3221 0929</telephone>
        <email>saeidshamlou9092@gmail.com</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeid Shamlou Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdiyeh Ave</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3221 0929</telephone>
        <email>saeidshamlou9092@gmail.com</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having high blood pressure</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of cardiovascular disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10-I15</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertensive crisis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: The exercise intervention in this research will be 8 weeks of combined aerobic and resistance exercises. 3 days a week (Saturday-Monday-Wednesday) from 5 to 6 in the evening by the subject. Aerobic training includes 30 minutes of non-stop walking from the first to the fourth week with an intensity of 40% of the maximum heart rate (MHR) 1 and from the fourth to the eighth week of the study with an intensity of 60% of the maximum heart rate (MHR), then warming up between the two exercises 10 repetitions of a movement and after 5 minutes 1RM2 test will be done and then resistance exercises will be done. Resistance exercises will be 30 minutes in the first 4 weeks with 40% intensity of a maximum repetition ("using 2 or 3 kg dumbbells and elastic resistance bands with yellow color (low intensity) of the brand ("RACINESS") and in the second 4 weeks with an intensity of 60% one maximum repetition ("using 4 or 5 kg dumbbells and resistance bands with blue color (medium intensity) brand RACINESS" ) are performed in 3 sets with 12 repetitions and 90 seconds rest between each set and 120 seconds between each exercise. Resistance exercises include horizontal leg press - rowing from the bottom (Low Row) - exercises Sitting with a chair (extensor chair) is a bench press exercise (chest and head). The supplement group also consumes 4.5 grams of spirulina supplement daily eensea.ir (provided by Danish Gulf Algae Technology Development Company), will be consumed by subjects in the form of 7 capsules of 600 mg per day. Chitosan supplement in the amount of 2 capsules in the specified dose of Karen company, each 500 mg before meals, is used by the subjects in the designated group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people whose blood pressure has decreased. Timepoint: Blood pressure measurement before and after the intervention. Method of measurement: Using a mercury sphygmomanometer (ALPK2) made in Japan.</prim_outcome>
      <prim_outcome>The percentage of people whose cholesterol, low-density lipoprotein and triglyceride levels have decreased. Timepoint: Measurement of lipid profile before and after the intervention. Method of measurement: By testing blood samples.</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>Danesh Alborz University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-02</approval_date>
        <contact_name>Ethics Committee of Sport Sciences Research Institute</contact_name>
        <contact_address>Fifth Alley, Mir Emad Ave., Ostad Motahari Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
