<?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>IRCT20190618043935N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-23</date_registration>
      <primary_sponsor>The university of Sistan and Baluchestan</primary_sponsor>
      <public_title>Effect of Low-Repetition and Light-Load Power Training on Post menopausal Women</public_title>
      <acronym></acronym>
      <scientific_title>Effect of 6 Weeks of Low-Repetition and Light-Load Power Training on Serum Levels of b-ALP and CTX in Postmenopausal Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47373</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: Randomization method: Simple Randomization, Randomization unit: individually, Randomization tool: Table of Random Numbers, How to make Randomization sequence: From the top to the end of list, Allocation Concealment: A third person allocate numbers to the participants then using table of Random Numbers another person select the numbers with closed eyes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Menopause. Condition 2: Osteoporosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Power trainings will be performed for 6 weeks, 5 sessions per week, 8 sets, 3 repetitions and 15 seconds rest between sets, including 5 activities (Scot, forward lounge, side lounge, cuff rise and toe rise) and to produce power in mentioned activities, the concentric phase should be done so fast in correct body straight posture. After 10 minutes of warm up the training starts and finished after 10 minutes of cool down. Intervention 2: Control group: No intervention has received.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shila Nayebifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, Danesh Ave., Daneshjo Blvd</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9897567</zip>
        <telephone>+98 54 3113 6813</telephone>
        <email>shila_nayebifar@ped.usb.ac.ir</email>
        <affiliation>The University of Sistan and Baluchestan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shila Nayebifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, Danesh Ave., Daneshjo Blvd.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>98976556</zip>
        <telephone>+98 54 3113 6813</telephone>
        <email>shila_nayebifar@ped.usb.ac.ir</email>
        <affiliation>The University of Sistan and Baluchestan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having  no exercise background
At least two years should be passed from their menopause time.
Not having any special problems such as cardiovascular, metabolic, kidney, orthopedic diseases.
No smoking.</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The exclusion criteria include applying any medication and food supplements, diet therapy.
Being in amenorrhea state</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Power trainings will be performed for 6 weeks, 5 sessions per week, 8 sets, 3 repetitions and 15 seconds rest between sets, including 5 activities (Scot, forward lounge, side lounge, cuff rise and toe rise) and to produce power in mentioned activities, the concentric phase should be done so fast in correct body straight posture. After 10 minutes of warm up the training starts and finished after 10 minutes of cool down.</i_keyword>
      <i_keyword>Control group: No intervention has received.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of Osteocalcin. Timepoint: At the beginning of program (before starting intervention) and at the end of program (48 hours after last training session). Method of measurement: Measurement of serum Osteocalcin will be assessed using a kit (Zell Bio, Germany) with a sensitivity of 0.026 ng/ml.</prim_outcome>
      <prim_outcome>Serum levels of Paratormone. Timepoint: At the beginning of program (before starting intervention) and at the end of program (48 hours after last training session). Method of measurement: Paratormon will be assessed using a kit (Zell Bio, Germany) with a sensitivity of 1.56 ng/ml.</prim_outcome>
      <prim_outcome>Serum levels of Sclerostin. Timepoint: At the beginning of program (before starting intervention) and at the end of program (48 hours after last training session). Method of measurement: Sclerostin will be assessed using Hangzhou Stabiopharm kit (China), with a sensitivity of 0.26 ng/ml and ELISA method.</prim_outcome>
      <prim_outcome>Serum levels of Bone Alkalin Phosphatase. Timepoint: At the beginning of program (before starting intervention) and at the end of program (48 hours after last training session). Method of measurement: Bone Alkalin Phosphatase will be assessed using Hangzhou Stabiopharm kit (China), with a sensitivity of 0.52 pmol/l and ELISA method.</prim_outcome>
      <prim_outcome>Serum levels of C- terminal telopeptides of type I collagen. Timepoint: At the beginning of program (before starting intervention) and at the end of program (48 hours after last training session). Method of measurement: C- terminal telopeptides of type I collagen will be assessed using Hangzhou Stabiopharm kit (China), with a sensitivity of 0.01ng/ml and ELISA method.</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>University of Sistan and Baluchestan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-22</approval_date>
        <contact_name>Ethics committee of Sistan and Baluchestan University</contact_name>
        <contact_address>Daneshgah Blvd Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
