<?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>IRCT20200208046418N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-27</date_registration>
      <primary_sponsor>Tehran Naft Hospital</primary_sponsor>
      <public_title>The effect of exercise on metastatic breast cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 8 weeks of resistance training on some tumor markers, liver enzymes, quality of life and fatigue in metastatic breast cancer patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70282</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This research consists of two training groups (intervention) and control (without intervention), Randomization description: The method of choosing a random sample is simple. In this method, first the list of names of all the members is written, then a score or number is assigned to each of them, and the required number is selected using a table of random numbers.
Because the studied population is small, the lottery method is used, that is, the names of people are written on a paper and placed inside the box, then the papers are removed one by one until the desired sample size is complete.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: resistance training (weight training), for 8 weeks, 3 times a week, 4 movements of the upper body and 4 movements of the lower body (based on the articles). At first, each person's 1RM is measured and the training intensity will be designed based on the person's initial power, the number of repetitions for each movement is 8 to 12 repetitions in 2 to 3 sets (all the above can be adjusted based on the person's power) all recommendations American College of Sports Medicine is considered for resistance training in breast cancer patients. Intervention 2: Control group: They do not receive any intervention.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All the information obtained from this research project will be published as an article. Personal information of patients will remain confidential forever.

When:
Time of publication of articles

To whom:
All those for whom the information of this research project can be useful.

Conditions:
The research results can be made available to all interested parties.

Where to obtain:
To the published articles of this research project.

How to obtain:
Basically, raw data is not available to anyone, the results of the project can be obtained through articles.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabaghe 3, Boloke Bahar1, Shahrake Kosar,Mydane Hesarak</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3197937551</zip>
        <telephone>+98 936 641 4003</telephone>
        <email>Somayeh.95.nazari@gmail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabaghe 3, Boloke Bahar1,Shahrake Kosar,Meydane Hesarak,</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3197937551</zip>
        <telephone>+98 936 641 4003</telephone>
        <email>Somayeh.95.nazari@gmail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Metastatic breast cancer patients undergoing hormone therapy in the last year
Absence of fatty liver
Inactivity in the last 6 months
Not having a medical prohibition to participate in sports activities
Absence of fracture and the possibility of its occurrence
Not having an abnormality limiting sports activity
Absence of cardiovascular and skeletal-muscular risk factors
Absence of uncontrolled pain
More than a month has passed since chemotherapy and radiotherapy</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of a fracture
Alcohol and smoking
Age less than 30 and more than 50
Patients who are in the treatment phase of chemotherapy or radiation therapy
Male patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of central portion of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: resistance training (weight training), for 8 weeks, 3 times a week, 4 movements of the upper body and 4 movements of the lower body (based on the articles). At first, each person's 1RM is measured and the training intensity will be designed based on the person's initial power, the number of repetitions for each movement is 8 to 12 repetitions in 2 to 3 sets (all the above can be adjusted based on the person's power) all recommendations American College of Sports Medicine is considered for resistance training in breast cancer patients.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tumor markers CEA، CA15-3. Timepoint: 24 hours before the intervention and 24 hours after the last training session. Method of measurement: Taking blood samples.</prim_outcome>
      <prim_outcome>Liver enzymes ALT, AST and ALP. Timepoint: 24 hours before the intervention and 24 hours after the last training session. Method of measurement: Taking blood samples.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: 24 hours before the intervention and 24 hours after the last training session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: 24 hours before the intervention and 24 hours after the last training session. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Razi University of Kermanshah</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran Naft Hospital</source_name>
      <source_name>Razi University of Kermanshah</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-04</approval_date>
        <contact_name>Razi University Research Ethics Committee</contact_name>
        <contact_address>Razi University, University Street, Taq Bostan Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
