<?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>IRCT20230803059019N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-20</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>The effects of three-months of exercise intervention on the levels of inflammatory factors in women with low socioeconomic status</public_title>
      <acronym></acronym>
      <scientific_title>The effects of three-months of exercise intervention on the levels of inflammatory factors in women with low socioeconomic status</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71953</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Intense physical activity, despite its various benefits for general health, can cause possible damage to various body tissues due to the increase in oxidative stress through the increase in the production of reactive species. How to regulate inflammatory responses in exercise protocols is different in different people. the existing research shows that sports activity can have different results based on the intensity and duration..</hc_freetext>
      <i_freetext>In this research, we will have two groups of subjects with a pre-test and post-test design, which will include an experimental group and a control group, the experimental group includes 40 healthy sedentary women with low socioeconomic status and the control group includes 20 healthy sedentary women with economic status It is of low social status in Islamshahr city. The exercise protocol (exercise instructions) will be based on ACSM's recommendations in the form of three sessions per week for 60 minutes, which will be designed by a researcher. The exercise protocol will include three stages of warming up the main part of the exercise and cooling down. The first stage 15 1 minute of warm-up (10 minutes of walking with moderate intensity, 5 minutes of stretching and rhythmic movements and movement exercises), the second stage of the main part of the exercise is 30 minutes (including selected exercises to improve cardiorespiratory endurance, muscular endurance, flexibility in a combination with equipment and with weight body) and the final 15-minute third stage (including 10 minutes of group games and entertainment to improve the spirit and collective vitality of the subjects and 5 minutes of light aerobic activity and stretching exercises will be performed..</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>Seyed Mohsen Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 2,Plates 6,ThreeOrchid Alley, Behesht Gharabi St.Hakimiya</address>
        <city>TEHRAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1651875579</zip>
        <telephone>+98 21 7730 4261</telephone>
        <email>mohsentrainer@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mohsen Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hakimiya, Behesht Gharabi St., Orchid Alley, Three Plates 6, Unit 2</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1651875579</zip>
        <telephone>+98 21 7730 4261</telephone>
        <email>mohsentrainer@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Sedentary healthy women
low socioeconomic status</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diseases affecting exercise intervention such as orthopedic diseases, neuromuscular or cardiovascular diseases
Prohibition of sports activities by the doctor</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this research, we will have two groups of subjects with a pre-test and post-test design, which will include an experimental group and a control group, the experimental group includes 40 healthy sedentary women with low socioeconomic status and the control group includes 20 healthy sedentary women with economic status It is of low social status in Islamshahr city. The exercise protocol (exercise instructions) will be based on ACSM's recommendations in the form of three sessions per week for 60 minutes, which will be designed by a researcher. The exercise protocol will include three stages of warming up the main part of the exercise and cooling down. The first stage 15 1 minute of warm-up (10 minutes of walking with moderate intensity, 5 minutes of stretching and rhythmic movements and movement exercises), the second stage of the main part of the exercise is 30 minutes (including selected exercises to improve cardiorespiratory endurance, muscular endurance, flexibility in a combination with equipment and with weight body) and the final 15-minute third stage (including 10 minutes of group games and entertainment to improve the spirit and collective vitality of the subjects and 5 minutes of light aerobic activity and stretching exercises will be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>TNF-alpha: anti-inflammatory cytokines are secreted in response to inflammation and are limiting and reversing the progressive process of inflammation. Timepoint: In two stages, pre-test and post-test. Method of measurement: Blood sampling and measurement by ELISA device.</prim_outcome>
      <prim_outcome>IL-10 : anti-inflammatory cytokines are secreted in response to inflammation and are limiting and reversing the progressive process of inflammation. Timepoint: In two stages, pre-test and post-test. Method of measurement: Blood sampling and measurement by ELISA device.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-10</approval_date>
        <contact_name>SHAHED UNIVERSITY</contact_name>
        <contact_address>Shahid University, Shahid Reza Ali Street, Shahid Oliya Blvd., Aftab City, Tehran TEHRAN Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
