<?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>IRCT20201203049583N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of beetroot juice supplementation on functional capacity in overweight women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of beetroot juice supplementation on functional capacity in overweight women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52814</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Women with inclusion criteria, after entering, are numbered in order and then identified by numbers.
At the first visit, each sample is entered into one of the two case and control groups by a table of random numbers
Even numbers are in one group and odd numbers are in another
Numbering and division into two groups without coordination with the patient, Blinding description: One group  is given of colored water (with authorized food colors) as a placebo and the other group is given beetroot juice, and this process is done by a person other than the researcher who is responsible for collecting data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the initial referral, how to perform and how to test is explained. In the second visit, the fatigue time test is performed using the Ramp protocol. 1RM test was taken for chest and leg presses. People are taught not to exercise 12 hours before the aerobic function test and to have breakfast two hours before the test, to avoid diuretics and alcohol at least 12 hours before the test, to use substances such as caffeine and chocolate. Limit 24 hours before the test. Tests are taken between 8 and 10 am. At the end of the test, the difficulty of understanding the work is recorded by the previously trained Borg visual index. The strength test was then performed at 70% 1RM in two sets with as many repetitions as they could perform, two minutes apart. At the end of each test, the perception of difficulty was recorded by the Borg visual index. 1RM is taken from patients by observing the above points. Intervention 2: Control group: The initial referral explains how to do and how to test. In the second visit, the fatigue time test is performed using the Ramp protocol. 1RM test was taken for chest and leg presses. People are taught not to exercise 12 hours before the aerobic function test and to have breakfast two hours before the test, to avoid diuretics and alcohol at least 12 hours before the test, to use substances such as caffeine and chocolate. Limit 24 hours before the test. Tests are taken between 8 and 10 am. At the end of the test, the difficulty of understanding the work is recorded by the previously trained Borg visual index. The strength test was then performed at 70% 1RM in two sets with as many repetitions as they could perform, two minutes apart. At the end of each test, the difficulty of understanding the work was recorded by the Borg visual index. RAMP test, chest press and leg press with 70% 1RM will be taken from patients by observing the above points.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Najmabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Sports Medicine, Imam Khomeini hospital, Dr Gharib Ave., End of Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119</telephone>
        <email>najmabadi.mina@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Najmabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Sports Medicine, Imam Khomeini hospital, Dr Gharib Ave., End of Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119</telephone>
        <email>najmabadi.mina@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with BMI 25 to 29.9 kg/m^2
Age range: 20-45 years old
Physical activity less than 90 minutes with moderate intensity per week in at least the last three months
No history of disease (uncontrolled diabetes, severe cardiovascular disease, musculoskeletal limitations and exercise-limiting neurological disorder, uncontrolled hypertension, chronic obstructive pulmonary disease)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Creating restrictive musculoskeletal problems that prevent continued physical activity
The presence of signs and symptoms that put a person at high risk for heart disease
Reluctance to continue cooperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the initial referral, how to perform and how to test is explained. In the second visit, the fatigue time test is performed using the Ramp protocol. 1RM test was taken for chest and leg presses. People are taught not to exercise 12 hours before the aerobic function test and to have breakfast two hours before the test, to avoid diuretics and alcohol at least 12 hours before the test, to use substances such as caffeine and chocolate. Limit 24 hours before the test. Tests are taken between 8 and 10 am. At the end of the test, the difficulty of understanding the work is recorded by the previously trained Borg visual index. The strength test was then performed at 70% 1RM in two sets with as many repetitions as they could perform, two minutes apart. At the end of each test, the perception of difficulty was recorded by the Borg visual index. 1RM is taken from patients by observing the above points</i_keyword>
      <i_keyword>Control group: The initial referral explains how to do and how to test. In the second visit, the fatigue time test is performed using the Ramp protocol. 1RM test was taken for chest and leg presses. People are taught not to exercise 12 hours before the aerobic function test and to have breakfast two hours before the test, to avoid diuretics and alcohol at least 12 hours before the test, to use substances such as caffeine and chocolate. Limit 24 hours before the test. Tests are taken between 8 and 10 am. At the end of the test, the difficulty of understanding the work is recorded by the previously trained Borg visual index. The strength test was then performed at 70% 1RM in two sets with as many repetitions as they could perform, two minutes apart. At the end of each test, the difficulty of understanding the work was recorded by the Borg visual index. RAMP test, chest press and leg press with 70% 1RM will be taken from patients by observing the above points.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional capacity ( Time to exhaustion in activity). Timepoint: Initial referral and referral on the 7th and 14th day. Method of measurement: Borg scale.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-15</approval_date>
        <contact_name>Ethics committee of Tehran university of medical science</contact_name>
        <contact_address>Building No. 1 of the Faculty of Medicine, First Floor, Office of the Vice Chancellor for Research, North Door of the University, Poursina St., Ghods St., Enghelab St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
