<?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>IRCT20190705044101N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of resistance training on growth and osteogenic factors of elderly women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a 12-weeks period of elastic band resistance training on some growth and osteogenic factors and its relationship with bone density in elderly osteosarcopenic obese women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40623</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After completing all initial assessments, subjects were grouped using binary block randomization to balance the number of samples assigned to the exercise and control groups in a 1: 1 ratio. The sealed envelope was also used because of the importance of hiding the random allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Osteosarcopenic obesity syndrome. Condition 2: postmenopausal osteoporosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Subjects in This Group Performed an Elastic Band (3 Sessions Per Week, Each Session for Approximately 60 minutes) for 12 Weeks.Practicing Intensity Control is Practiced Using the Targeted Repeat Count (TNRs) and the OMNI Resistance Training Scale.In order to Comply with the Principle of Overload After Every 2 Weeks of Training, The Intensity of Exercise is Increased by Using the Elastic Band Color Change (yellow, red, blue, green, black, silver), Respectively.Participants in This Group Follow Their Past Food Plans. Intervention 2: Control group: The subjects in This Group do Their Routine Activities within 12 Weeks.Participants in This Group Follow Their Past Food Plans.</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>Ebrahim Banitalebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord University, Rahbar blvd</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۸۶۳۴۱۴۱</zip>
        <telephone>+98 38 3232 4401</telephone>
        <email>banitalebi.e@gmail.com</email>
        <affiliation>The University of Shahrekord</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad Faramarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University of Shahrekord, Rahbar Blvd</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۸۶۳۴۱۴۱</zip>
        <telephone>+98 38 3232 4407</telephone>
        <email>md.faramarzi@gmail.com</email>
        <affiliation>The University of Shahrekord</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 60 years
Body fat percent over 32% or BMI over 30
T-score less than -1.0
Hand grip less than 21kg
Skeletal mass index (SMI) less than %28</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having parallel physical exercises
Following a weight loss diet of more than 5 kg in the last three months
Chronic illness such as hypertension, thyroid or kidney problems, diabetes, cancer
very severe osteoporosis
Hormone therapy or any drug that affects bone density, adipose tissue, or the hormonal system.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code>M81.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Subjects in This Group Performed an Elastic Band (3 Sessions Per Week, Each Session for Approximately 60 minutes) for 12 Weeks.Practicing Intensity Control is Practiced Using the Targeted Repeat Count (TNRs) and the OMNI Resistance Training Scale.In order to Comply with the Principle of Overload After Every 2 Weeks of Training, The Intensity of Exercise is Increased by Using the Elastic Band Color Change (yellow, red, blue, green, black, silver), Respectively.Participants in This Group Follow Their Past Food Plans.</i_keyword>
      <i_keyword>Control group: The subjects in This Group do Their Routine Activities within 12 Weeks.Participants in This Group Follow Their Past Food Plans.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Myostatin. Timepoint: 24 hours before the intervention and 48 hours after the end of the last training session. Method of measurement: Elisa Kit (Pack of 96).</prim_outcome>
      <prim_outcome>Follistatin. Timepoint: 24 hours before the intervention and 48 hours after the end of the last training session. Method of measurement: Elisa Kit (Pack of 96).</prim_outcome>
      <prim_outcome>Insulin-like growth factor 1(IGF-1). Timepoint: 24 hours before the intervention and 48 hours after the end of the last training session. Method of measurement: Elisa Kit (Pack of 96).</prim_outcome>
      <prim_outcome>Fibroblast Growth Factor2(FGF-2). Timepoint: 24 hours before the intervention and 48 hours after the end of the last training session. Method of measurement: Elisa Kit( Pack of 96).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bone Densitometry. Timepoint: One week Before the Intervention and one Week After the Last Training Session. Method of measurement: dual-energy X-ray absorptiometry (DXA).</sec_outcome>
      <sec_outcome>Body Fat Percent. Timepoint: One week Before the Intervention and one Week After the Last Training Session. Method of measurement: Use the Harpernet model calipers.</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>Shahrekord University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-11</approval_date>
        <contact_name>Ethics committee of Sport Sciences Research Institute</contact_name>
        <contact_address>No.3, fifth Alley, Mir Emad Ave, Ostad Motahari street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
