<?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>IRCT20230131057292N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-19</date_registration>
      <primary_sponsor>University of Tehran</primary_sponsor>
      <public_title>Effects of resistance training and sour tea consumption on hypertension</public_title>
      <acronym></acronym>
      <scientific_title>The effect of resistance training and sour tea (Hibiscus sabdariffa) consumption on leptin and adiponectin adipokines in hypertensive elderly men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68487</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this research, subjects are selected by Simple randomization by the random allocation rule. After determining the sample size, they will be equally divided into 4 groups.  Using the lottery method, the names of the subjects are written on separate papers and placed in a container, then the names of the subjects are randomly taken out and placed in the intervention groups or placebo, respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The training group will do 12 weeks and 3 sessions of resistance training program every week. Resistance exercises include 9 exercises (2 sets/12-15 repetitions) plus 10 minutes of warm-up and cool-down before and after exercise. The main training phase includes upper body exercises (chest press, latissimus dorsi pulldown, back row, biceps curl), lower body exercises (leg press, leg extension, leg curl) and middle body exercises (abdominal crunch, lower back extension). . Intervention 2: Intervention group: Sour tea group for 12 weeks and daily consumption of 2 grams of sour tea dissolved in 240 ml of water. Intervention 3: Intervention group: resistance exercises + sour tea for 12 weeks and will do resistance exercises 3 times a week. Resistance exercises include 9 exercises (2 sets/12-15 repetitions) plus 10 minutes of warm-up and cool-down before and after exercise. The main training phase includes upper body exercises (chest press, latissimus dorsi pulldown, back row, biceps curl), lower body exercises (leg press, leg extension, leg curl) and middle body exercises (abdominal crunch, lower back extension). . In addition, every day, 2 servings of sour tea will be consumed in the amount of 2 grams dissolved in 240 ml of water. Intervention 4: Control group: The control group does not do resistance exercise and does not consume sour tea.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Babak Hoshmand moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Mashhad, Azadi Sq, Ferdowsi university of Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 3880 5000</telephone>
        <email>b.hooshmand.m@gmail.com</email>
        <affiliation>Ferdowsi University of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shima Mojtahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439813117</zip>
        <telephone>+98 21 6111 8872</telephone>
        <email>shmojtahedi@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men aged between 55 and 70 years
Hypertensive
Taking hypertension drugs
Completion of the informed consent form</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>using beta blockers drugs
having a history of heart surgery
suffering from metabolic diseases
alcohol
participating in regular physical activities in the six months before the time of the study
smoking
suffering from inflammatory diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Essential </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>I10</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The training group will do 12 weeks and 3 sessions of resistance training program every week. Resistance exercises include 9 exercises (2 sets/12-15 repetitions) plus 10 minutes of warm-up and cool-down before and after exercise. The main training phase includes upper body exercises (chest press, latissimus dorsi pulldown, back row, biceps curl), lower body exercises (leg press, leg extension, leg curl) and middle body exercises (abdominal crunch, lower back extension). .</i_keyword>
      <i_keyword>Intervention group: Sour tea group for 12 weeks and daily consumption of 2 grams of sour tea dissolved in 240 ml of water.</i_keyword>
      <i_keyword>Intervention group: resistance exercises + sour tea for 12 weeks and will do resistance exercises 3 times a week. Resistance exercises include 9 exercises (2 sets/12-15 repetitions) plus 10 minutes of warm-up and cool-down before and after exercise. The main training phase includes upper body exercises (chest press, latissimus dorsi pulldown, back row, biceps curl), lower body exercises (leg press, leg extension, leg curl) and middle body exercises (abdominal crunch, lower back extension). . In addition, every day, 2 servings of sour tea will be consumed in the amount of 2 grams dissolved in 240 ml of water.</i_keyword>
      <i_keyword>Control group: The control group does not do resistance exercise and does not consume sour tea.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic an diastolic blood pressure. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation. Method of measurement: Sphygmomanometer and stethoscope.</prim_outcome>
      <prim_outcome>Serum leptin levels. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation. Method of measurement: Using the human ELISA diagnostic kit related to the variable.</prim_outcome>
      <prim_outcome>Adiponectin. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation. Method of measurement: Using the human ELISA diagnostic kit related to the variable.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight changes. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation. Method of measurement: scale.</sec_outcome>
      <sec_outcome>Waist to hip ratio. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation. Method of measurement: tape meter.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation. Method of measurement: Bioelectrical impedance device.</sec_outcome>
      <sec_outcome>Fat index. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation. Method of measurement: Bioelectrical impedance 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>University of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-17</approval_date>
        <contact_name>Ethics Committee in Research, Faculty of Physical Education and Sports Sciences, University of Tehra</contact_name>
        <contact_address>Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
