<?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>IRCT20200222046579N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-30</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>the effect of physical activity training program on depression and anxiety in Postmenopausal Women</public_title>
      <acronym></acronym>
      <scientific_title>the effect of trans-theoretical model based physical activity training program on depression and anxiety in Postmenopausal Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46175</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization method and explanations: The stochasticization method is based on gradual references and having inclusion criteria and interest in participating in the study. Randomization unit: Individual Randomization layers: Random Allocation software type: Random Allocation software How to make a random sequence: Sequence Explanation about allocation concealment: Individuals included in the study, using a random method into two groups (intervention and control ) Are allocated. Randomization sequences will be generated based on 4 random permutation blocks using a web-based software. The randomization sequence will be provided to the project manager and will be hidden from the person participating in the study and the evaluator's colleague to enter the study until the intervention, Blinding description: In this single-blind study, only researchers are aware of which group of intervention and control individuals are in, and individuals are not aware of which type of training they receive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>depression and anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: People who are in stages 1 to 3 of behavior change, training is 10 sessions per week, the first 5 sessions are held only for the first subgroup of the intervention and the next 5 sessions for all members of the intervention group. At the beginning, general information questionnaires, IPAQ physical activity and transtheoretical model constructs are completed for each person in person. The training is based on a transtheoretical model of physical activity. And at the end of each session, a summary of training is provided to individuals. Intervention 2: Intervention group 2: People in the operation and maintenance stages, receiving 5 weekly training sessions, at the beginning of the work, general information questionnaires, IPAQ physical activity and transtheoretical model constructs for each person are completed in person. The training is based on a transtheoretical model of physical activity. And at the end of each session, a summary of training is provided to individuals. Intervention 3: Control group: Control group: do not receive any training during the study.</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 There is no mor information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Gholam bareshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 45, Abshar Alley, Valiasr St., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1434743397</zip>
        <telephone>+98 51 4261 3898</telephone>
        <email>parisagholami1997@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Gholam bareshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 45, Abshar Alley, Valiasr St., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1434743397</zip>
        <telephone>+98 51 4261 3898</telephone>
        <email>parisagholami1997@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 women aged 56-45 years
Elementary literacy (reading and writing)
Residence in the study area
No use of herbal or chemical drugs to reduce menopausal symptoms in the past 1 month</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>56 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having certain diseases and disorders that cause lifestyle changes or physical activity such as cancer, diabetes, cardiovascular disease, disability, respiratory distress
Exercise professionally</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mood disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: People who are in stages 1 to 3 of behavior change, training is 10 sessions per week, the first 5 sessions are held only for the first subgroup of the intervention and the next 5 sessions for all members of the intervention group. At the beginning, general information questionnaires, IPAQ physical activity and transtheoretical model constructs are completed for each person in person. The training is based on a transtheoretical model of physical activity. And at the end of each session, a summary of training is provided to individuals.</i_keyword>
      <i_keyword>Intervention group 2: People in the operation and maintenance stages, receiving 5 weekly training sessions, at the beginning of the work, general information questionnaires, IPAQ physical activity and transtheoretical model constructs for each person are completed in person. The training is based on a transtheoretical model of physical activity. And at the end of each session, a summary of training is provided to individuals.</i_keyword>
      <i_keyword>Control group: Control group: do not receive any training during the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of anxiety. Timepoint: Before training and after 6 months. Method of measurement: Depression and physical activity questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy related to physical activity. Timepoint: Before training and after 6 months. Method of measurement: Depression and physical activity questionnaire.</prim_outcome>
      <prim_outcome>Level of depression. Timepoint: Before training and after 6 months. Method of measurement: Depression and physical activity questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of physical activity. Timepoint: Before and 6 months after training. Method of measurement: Questionnaire and number of correct answers.</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 of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-01</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
