<?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>IRCT20200625047917N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of Water-Based rhythmic exercise training in postmenopausal women with Metabolic Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Water-Based rhythmic exercise training on Leptin, Aldosterone and Cardiovascular risk factors in postmenopausal women with Metabolic Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49210</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Subjects were divided into two groups (one control group and one experimental group) using the simple random method. This sampling will be done based on the red and blue balls inside the box that are randomly taken by the subjects (the red ball of the control group and the blue ball of the experimental group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Metabolic Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:12 weeks of Water-Based rhythmic exercise training ,three sessions per week, 60 minutes each session. Exercise training program consists of 10 minutes warming up, 45 minutes Water-Based rhythmic exercise training and 5 minutes cooling down. Intervention 2: Control group: Without intervention.</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 No decision has been made yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hanieh Berahman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht Branch, Islamic Azad University, Taleshan Bridge</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>hanie_berahman@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Alireza Elmiyeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lakan St., Poltaleshan Blv. , Rasht, Gilan, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>elmieh@iaurasht.acir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having age ranges of 65-75 years
Postmenopausa
No regular exercise
Suffering from at least three of the five indicators of metabolic syndrome: abdominal obesity (waist circumference more than 88 cm), triglycerides greater than 150 mg / dl, blood pressure more than 130.85 ml of mercury, fasting blood glucose more than 110 ml / dl And high-density lipoprotein (HDL) less than 50 mg / dl
Lack of diabetes, liver, kidney, inflammation and respiratory diseases</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>More than three session absence from the training
injury during training</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:12 weeks of Water-Based rhythmic exercise training ,three sessions per week, 60 minutes each session. Exercise training program consists of 10 minutes warming up, 45 minutes Water-Based rhythmic exercise training and 5 minutes cooling down</i_keyword>
      <i_keyword>Control group: Without intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aldosterone. Timepoint: Before and after the end of interventions. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>Leptin. Timepoint: Before and after the end of interventions. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>High-sensitivity C-reactive Protein (hs-CRP). Timepoint: Before and after the end of interventions. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>Fast blood sugar. Timepoint: Before and after the end of interventions. Method of measurement: using ELISA Kit.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before and after the end of interventions. Method of measurement: Using the blood pressure device.</prim_outcome>
      <prim_outcome>Insulin hormone. Timepoint: Before and after the end of interventions. Method of measurement: Serum levels using Eliza method.</prim_outcome>
      <prim_outcome>Albumin. Timepoint: Before and after the end of interventions. Method of measurement: Using Colorimetric.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before and after the end of interventions. Method of measurement: According to milligrams per deciliter and by Baseline blood.</prim_outcome>
      <prim_outcome>Low-density lipoprotein. Timepoint: Before and after the end of interventions. Method of measurement: According to milligrams per deciliter and by Baseline blood.</prim_outcome>
      <prim_outcome>High-density lipoprotein. Timepoint: Before and after the end of interventions. Method of measurement: According to milligrams per deciliter and by Baseline blood.</prim_outcome>
      <prim_outcome>Cholstrol. Timepoint: Before and after the end of interventions. Method of measurement: According to milligrams per deciliter and by Baseline blood.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: Before and after the end of interventions. Method of measurement: According to cm and by Tape measure.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: Before and after the end of interventions. Method of measurement: According to Kg/m2 and dividing body weight by the square of the height(m2).</prim_outcome>
      <prim_outcome>Fat percent. Timepoint: Before and after the end of interventions. Method of measurement: Using InBody.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>TSH. Timepoint: before and after the end of intervention. Method of measurement: using ELISA Kit.</sec_outcome>
      <sec_outcome>T4. Timepoint: before and after the end of intervention. Method of measurement: using ELISA Kit.</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>2020-06-22</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University Rasht Branch</contact_name>
        <contact_address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
