<?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>IRCT20210413050954N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-31</date_registration>
      <primary_sponsor>Shahroud School of Physical Education</primary_sponsor>
      <public_title>The effect of eight weeks of Pilates exercise and jujube supplementation on liver fat content, liver enzymes and platelet count in women with non-alcoholic fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of Pilates exercise and jujube supplementation on liver fat content, liver enzymes and platelet count in women with non-alcoholic fatty liver</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55657</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The lottery method will be used for random allocation. This method is a large block the size of the total sample size to ensure a balance in the number of people assigned to each group. For this purpose, we put the same size of the sample (40 pieces) of the same shape card on which the numbers 1 to 40 are written in the same shape of the envelope and place it in a lottery container. Then randomly remove the cards and number the first 10 cards for group A (Pilates exercise), the next 10 cards for group B (Pilates and jujube), the third 10 cards for group C (jujube only) and the last 10 cards for group D (Control group) is written, the random chain of numbers and assigned groups are specified. Candidates are numbered in order of date and assigned to the groups based on the written sequence.</study_design>
      <phase>N/A</phase>
      <hc_freetext>non-alcoholic fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group, only jujube consumption: daily consumption of 0.4 grams of jujube fruit per kilogram of body weight will be consumed in the morning and the same amount in the evening. Intervention 2: The second intervention group, Pilates Exercise Only: The Pilates training protocol will include 60 minutes of activity in the form of 10 minutes of warm-up, 40 minutes of Pilates exercises, and 10 minutes of cooling in three sessions per week for eight weeks. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. It is done lying down and without the need for specialized equipment. In order to observe the principle of overload, the speed and repetition of movements in each session will increase compared to the previous session, so that it starts from 10 repetitions in the first week and will gradually reach 25-25 repetitions in the eighth week. Also, to control the intensity of the exercises, the formula of maximum heart rate (age -220 = maximum heart rate) and polar heart rate monitor will be used. Accordingly, exercise will begin in the first week with an intensity of 55-50% of maximum heart rate and in the eighth week will reach 75-80% of maximum heart rate (approximately 5% increase in intensity of exercise per week). It should be noted that the control group and the jujube extract group will not participate in any training or sports activities during these eight weeks. Intervention 3: Intervention group: The third intervention group, Pilates training and jujube consumption: will consume 0.4 grams of jujube fruit per kilogram of body weight daily in the morning and the same amount in the evening. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. It is done lying down and without the need for specialized equipment. In order to observe the principle of overload, the speed and repetition of movements in each session will increase compared to the previous session, so that it starts from 10 repetitions in the first week and will gradually reach 25-25 repetitions in the eighth week. Also, to control the intensity of the exercises, the formula of maximum heart rate (age -220 = maximum heart rate) and polar heart rate monitor will be used. Accordingly, exercise will begin in the first week with an intensity of 55-50% of maximum heart rate and in the eighth week will reach 75-80% of maximum heart rate (approximately 5% increase in intensity of exercise per week). It should be noted that the control group and the jujube extract group will not participate in any training or sports activities during these eight weeks. Intervention 4: Control group: they will not be interfered with.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>rasoul raesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>modarres15</address>
        <city>khaf</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9561717551</zip>
        <telephone>+98 51 5422 9501</telephone>
        <email>raesi.br881@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>rasoul raesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>modarres15</address>
        <city>khaf</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9561717551</zip>
        <telephone>+98 51 5422 6054</telephone>
        <email>raesi.br881@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Middle-aged women ranging in age from 31 to 49
Satisfaction to participate in the study
BMI 30 or less
Fatty liver grade one and above</inclusion_criteria>
      <agemin>31 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of other diseases
Alcohol and tobacco consumption
Special diet / medication
Take dietary supplements
Regular exercise in the last six months</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 - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group, only jujube consumption: daily consumption of 0.4 grams of jujube fruit per kilogram of body weight will be consumed in the morning and the same amount in the evening.</i_keyword>
      <i_keyword>The second intervention group, Pilates Exercise Only: The Pilates training protocol will include 60 minutes of activity in the form of 10 minutes of warm-up, 40 minutes of Pilates exercises, and 10 minutes of cooling in three sessions per week for eight weeks. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. It is done lying down and without the need for specialized equipment. In order to observe the principle of overload, the speed and repetition of movements in each session will increase compared to the previous session, so that it starts from 10 repetitions in the first week and will gradually reach 25-25 repetitions in the eighth week. Also, to control the intensity of the exercises, the formula of maximum heart rate (age -220 = maximum heart rate) and polar heart rate monitor will be used. Accordingly, exercise will begin in the first week with an intensity of 55-50% of maximum heart rate and in the eighth week will reach 75-80% of maximum heart rate (approximately 5% increase in intensity of exercise per week). It should be noted that the control group and the jujube extract group will not participate in any training or sports activities during these eight weeks.</i_keyword>
      <i_keyword>Intervention group: The third intervention group, Pilates training and jujube consumption: will consume 0.4 grams of jujube fruit per kilogram of body weight daily in the morning and the same amount in the evening. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. It is done lying down and without the need for specialized equipment. In order to observe the principle of overload, the speed and repetition of movements in each session will increase compared to the previous session, so that it starts from 10 repetitions in the first week and will gradually reach 25-25 repetitions in the eighth week. Also, to control the intensity of the exercises, the formula of maximum heart rate (age -220 = maximum heart rate) and polar heart rate monitor will be used. Accordingly, exercise will begin in the first week with an intensity of 55-50% of maximum heart rate and in the eighth week will reach 75-80% of maximum heart rate (approximately 5% increase in intensity of exercise per week). It should be noted that the control group and the jujube extract group will not participate in any training or sports activities during these eight weeks.</i_keyword>
      <i_keyword>Control group: they will not be interfered with.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver fat content. Timepoint: 48 hours before the intervention and 48 hours after the intervention. Method of measurement: Diagnostic ultrasound of fatty liver.</prim_outcome>
      <prim_outcome>Liver enzymes. Timepoint: 48 hours before the intervention and 48 hours after the intervention. Method of measurement: Blood biochemistry tests.</prim_outcome>
      <prim_outcome>Platelet count. Timepoint: 48 hours before the intervention and 48 hours after the intervention. Method of measurement: Blood Cell Counting Test (CBC).</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>no</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-19</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>modarres 15 khaf Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
