<?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>IRCT20150531022498N23</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-06</date_registration>
      <primary_sponsor>Rasht Azad University</primary_sponsor>
      <public_title>A comparison of the effects of 12  weeks walking with two different intensities on the expression of circulating miR-146a, miR-181a and Plasma levels of inflammatory markers IL-6 and TNF-α In Sedentary Aged Women.</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of the effects of 12  weeks walking with two different intensities on the expression of circulating miR-146a and miR-181a and Plasma levels of inflammatory markers IL-6 and TNF-α In Sedentary Aged Women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30511</url>
      <study_type>observational</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Subjects were divided into 3 groups (one control group and 2 experimental groups) using the random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diseases associated with aging and inflammation.</hc_freetext>
      <i_freetext>Intervention 1: The first Intervention group: moderate intensity of walking, In this group, the subjects will be walking(55-50% of the target heart rate) for 12 weeks and 3 sessions in a week. The workout time of the first week will begin at 30 minutes and will increase to 45 minutes at the end of the sixth week. The intensity of exercise in the first six weeks will be 50% of the maximum heart rate reserved and in the second six weeks it will be 55%. Intervention 2: The second Intervention group: High intensity of walking,In this group, the subjects will be walking(70-75% of the target heart rate) for 12 weeks and 3 sessions in a week. The workout time of the first week will begin at 30 minutes and will increase to 45 minutes at the end of the sixth week. The intensity of exercise in the first six weeks will be 70% of the maximum heart rate reserved and in the second six weeks it will be 75%. Intervention 3: Control group: Without any intervention, subjects in this group will continue their normal routine during the 12-week study period.</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>Fateme Falah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Squ,.Baghestan St,. Alborz province</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3193747846</zip>
        <telephone>+98 26 3452 4701</telephone>
        <email>fatemefalah1363@gmail.com</email>
        <affiliation>Rasam university of Alborz province</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Falah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina St, District 4, Rasht., Guilan Province.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>fatemefalah1363@gmail.com</email>
        <affiliation>The University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women
Age range 60 to 75
Inactive</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having any chronic and inflammatory disease
Having any particular diet or medication during the study period
Use of auxiliary equipment for walking
Motor limitation in the pelvic, hip and knee joints</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first Intervention group: moderate intensity of walking, In this group, the subjects will be walking(55-50% of the target heart rate) for 12 weeks and 3 sessions in a week. The workout time of the first week will begin at 30 minutes and will increase to 45 minutes at the end of the sixth week. The intensity of exercise in the first six weeks will be 50% of the maximum heart rate reserved and in the second six weeks it will be 55%.</i_keyword>
      <i_keyword>The second Intervention group: High intensity of walking,In this group, the subjects will be walking(70-75% of the target heart rate) for 12 weeks and 3 sessions in a week. The workout time of the first week will begin at 30 minutes and will increase to 45 minutes at the end of the sixth week. The intensity of exercise in the first six weeks will be 70% of the maximum heart rate reserved and in the second six weeks it will be 75%.</i_keyword>
      <i_keyword>Control group: Without any intervention, subjects in this group will continue their normal routine during the 12-week study period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plasma level of miR-146a. Timepoint: Before and after the end of 12 weeks of training. Method of measurement: Using by polymerase chain reaction (PCR).</prim_outcome>
      <prim_outcome>Plasma level of microRNA-181a. Timepoint: Before and after the end of 12 weeks of training. Method of measurement: Using by polymerase chain reaction (PCR).</prim_outcome>
      <prim_outcome>Plasma level of Interleukin-6. Timepoint: Before and after the end of 12 weeks of training. Method of measurement: Serum level using ELISA Kit.</prim_outcome>
      <prim_outcome>Plasma level of Tumor necrosis factor alpha (TNF-α). Timepoint: Before and after the end of 12 weeks of training. Method of measurement: Serum level using ELISA Kit.</prim_outcome>
      <prim_outcome>White blood cell counts. Timepoint: Before and after the end of 12 weeks of training. Method of measurement: Using blood sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure variables. Timepoint: Before and after the end of 12 weeks of training. Method of measurement: Rest levels using by measurement of systolic blood pressure, diastolic blood pressure and heart rate.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before and after the end of 12 weeks of training. Method of measurement: Using by quality of life questionnaire (SF-36).</sec_outcome>
      <sec_outcome>Body composition. Timepoint: Before and after the end of 12 weeks of training. Method of measurement: Using by measurement of weight, body mass index (BMI), fat percent, fat free mass and waist circumference.</sec_outcome>
      <sec_outcome>Physical fitness. Timepoint: Before and after the end of 12 weeks of training. Method of measurement: Using by measurement of dynamic and static balance and maximum oxygen consumption (VO2max).</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>Rasht Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-19</approval_date>
        <contact_name>Ethics committee of Rasht Azad University</contact_name>
        <contact_address>lbn Sina St, District 4, Rasht., Gilan Province. Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
