<?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>IRCT20211017052792N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-13</date_registration>
      <primary_sponsor>Shahid Beheshti University</primary_sponsor>
      <public_title>The effect of resistance training on improving bone mineral density</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of resistance training on women's bone parameters, before and after menopause</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59417</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The present study consists of 4 postmenopausal groups (intervention and control) and non-menopausal group (intervention and control).
 We use the classification randomization method to randomize the sample selection. In this method, participants are placed in two classes A and B based on menopausal status factor (menopause and non-menopause) and then in each class, simple randomization (lottery) is used to select samples for the intervention and control groups, Blinding description: In the present study, blindness is one-sided and due to the fact that the researcher interviews individuals personally and after the study description and obtaining written consent, puts them under medical intervention or control group, the researcher assigns individuals and groups.
 It is aware and only patients do not know which group they belong to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Decreased bone density in postmenopausal and non-menopausal women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Due to individual differences and a maximum repetition, ie the maximum weight that a person can move for one time, resistance exercises with dumbbells with an intensity of 70 to 85% of a maximum repetition and 8 to 12 repetitions on the extensor muscles of the trunk and front muscles.And the back of the foot is done for 4 months. It should be noted that the duration of the exercises, taking into account warm-up and cooling, is 60 minutes. Intervention 2: Intervention group 2 (non-menopausal group): Non-menopausal group such as menopausal group due to individual differences and a maximum repetition means the maximum weight that a person can move for one time. And 8 to 12 repetitions are done on the extensor muscles of the trunk and the muscles of the front and back of the leg for 4 months. It should be noted that the duration of the exercises is 60 minutes, taking into account warm-up and cooling. Intervention 3: Control group: The postmenopausal control group and the non-menopausal control group resume their normal daily activities for 4 months and avoid taking bone density medication.</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 I have not decided yet - the release schedule is still unknown</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.12, west Imam Khomeini, Rey town, tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1865816548</zip>
        <telephone>+98 21 3340 5980</telephone>
        <email>fatemeghorbani731@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.12, west Imam Khomeini, Rey town, tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1865816548</zip>
        <telephone>+98 21 3340 5980</telephone>
        <email>fatemeghorbani731@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Postmenopausal and non-menopausal women in the age range of 40 to 60 years with osteopenia approved by an endocrinologist
weight in the normal range and with a body mass index between 18 and 25 according to the criteria of the World Health Organization</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Any fractures or surgery on the lower limbs and spine
hormone intake that affects bone tissue metabolism
pre-hormone therapy and exercise in the past 6 months and during the study period
people with joint diseases such as osteoarthritis and osteoarthritis In the lower limbs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M81.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Age-related osteoporosis without current pathological fracture</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Due to individual differences and a maximum repetition, ie the maximum weight that a person can move for one time, resistance exercises with dumbbells with an intensity of 70 to 85% of a maximum repetition and 8 to 12 repetitions on the extensor muscles of the trunk and front muscles.And the back of the foot is done for 4 months. It should be noted that the duration of the exercises, taking into account warm-up and cooling, is 60 minutes.</i_keyword>
      <i_keyword>Intervention group 2 (non-menopausal group): Non-menopausal group such as menopausal group due to individual differences and a maximum repetition means the maximum weight that a person can move for one time. And 8 to 12 repetitions are done on the extensor muscles of the trunk and the muscles of the front and back of the leg for 4 months. It should be noted that the duration of the exercises is 60 minutes, taking into account warm-up and cooling.</i_keyword>
      <i_keyword>Control group: The postmenopausal control group and the non-menopausal control group resume their normal daily activities for 4 months and avoid taking bone density medication.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of exercise on bone mineral density. Timepoint: Measurement of bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention. Method of measurement: Bone Density Tester.</prim_outcome>
      <prim_outcome>The effect of exercise on bone mineral content. Timepoint: Measurement of bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention. Method of measurement: Bone Density Tester.</prim_outcome>
      <prim_outcome>The effect of exercise on bone Z- score. Timepoint: Measurement of bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention. Method of measurement: Bone Density Tester.</prim_outcome>
      <prim_outcome>The effect of exercise on bone T-score. Timepoint: Measurement of bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention. Method of measurement: Bone Density Tester.</prim_outcome>
      <prim_outcome>The effect of exercise on bone area. Timepoint: Measurement of bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention. Method of measurement: Bone Density Tester.</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>Shahid Beheshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-26</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Tehran</contact_name>
        <contact_address>Daneshjoo Blvd,Shahid Shahriari Square,Yemen St.,Chamran Highway,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
