<?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>IRCT20210602051478N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-17</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of physical activity training  on quality of life  in women aged 40 to 50 years</public_title>
      <acronym></acronym>
      <scientific_title>The effect of physical activity training based on health belief model on quality of life during menopause in women 40 to 50 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56758</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Blinding description: In this study, the person in charge of data analysis does not know which codes belong to the intervention group and which codes belong to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>perimenopause period.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Educational intervention is divided into two parts: teaching concepts based on model structures and teaching sport exercises. The concepts are sent to participants in the form of packages of videos, podcasts, posters and text messages every two weeks in the WhatsApp group. They have two weeks to think and discuss and provide feedback on the submitted content. Individuals are asked to send their feedback in the form of an audio or text message to the group as desired. If people do not respond in the form of a message They are privately questioned. Exercise training: Aerobics training, endurance and stretching exercises at home online by the exercise instructor, 3 sessions per week, each session for 40 minutes, for 2 months. Video sessions will be provided to participants. In addition, the poster And the gif of exercises will be presented in the group. At the end, the educational content will be provided to the participants in the form of DVDs and booklets. Intervention 2: Control group: no intervention is performed on them.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahboobeh Amini Neisiany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Laleh St., Golrokh Alley, Islamic Alley, No. 20</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8198335631</zip>
        <telephone>+98 31 3448 9373</telephone>
        <email>klmnam789@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Asieh pirzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education, Faculty of Health, Isfahan University of Medical Sciences, Hezar Jarib St.</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673661</zip>
        <telephone>+98 31 3792 3340</telephone>
        <email>as_pirzadeh@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women in their 40s and 50s who have entered menopause (who report signs of changes in menstrual cycles)
Housewives with active records in health centers
At the doctor's discretion, they are not prohibited from doing aerobic exercise and endurance and stretching exercises
Lack of regular regular physical activity in the last 3 months (150 minutes per week)
No
No
Having a phone with the possibility of installing WhatsApp software and the ability to work with it</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>premature menopause
use of estrogen in the last three months</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Educational intervention is divided into two parts: teaching concepts based on model structures and teaching sport exercises. The concepts are sent to participants in the form of packages of videos, podcasts, posters and text messages every two weeks in the WhatsApp group. They have two weeks to think and discuss and provide feedback on the submitted content. Individuals are asked to send their feedback in the form of an audio or text message to the group as desired. If people do not respond in the form of a message They are privately questioned. Exercise training: Aerobics training, endurance and stretching exercises at home online by the exercise instructor, 3 sessions per week, each session for 40 minutes, for 2 months. Video sessions will be provided to participants. In addition, the poster And the gif of exercises will be presented in the group. At the end, the educational content will be provided to the participants in the form of DVDs and booklets.</i_keyword>
      <i_keyword>Control group: no intervention is performed on them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical activity score. Timepoint: Before the intervention and two months after the intervention. Method of measurement: questionnaire IPAQ.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before the intervention and two months after the intervention. Method of measurement: questionnaire MENQOL.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Perceived sensitivity score to the effects of sedentary lifestyle. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Health Belief Model of Physical Activity Questionnaire.</sec_outcome>
      <sec_outcome>Perceived severity score to sedentary effects. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Health Belief Model of Physical Activity Questionnaire.</sec_outcome>
      <sec_outcome>Score the perceived benefits of physical activity. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Health Belief Model of Physical Activity Questionnaire.</sec_outcome>
      <sec_outcome>Awareness score. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Health Belief Model of Physical Activity Questionnaire.</sec_outcome>
      <sec_outcome>Score perceived barriers to physical activity. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Health Belief Model of Physical Activity Questionnaire.</sec_outcome>
      <sec_outcome>Self-efficacy score. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Health Belief Model of Physical Activity Questionnaire.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-26</approval_date>
        <contact_name>Ethics committee of Esfahan  University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Building No. 4, Vice Chancellor for Research and Technology Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
