<?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>IRCT20231103059935N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-25</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Resistance exercise on pain, fatigue and mobility in breast cancer survivors                                    `</public_title>
      <acronym></acronym>
      <scientific_title>Effects of resistance exercise on pain, fatigue and mobility in breast cancer survivors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73586</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: Wall push-ups, Scapular squeeze, and Resistance bands exercises for resistance training, Randomization description: Participants were randomly allocated into two groups through computer generated list. Simple randomization. Unit of randomization is individual and tool used in randomization is sealed envelops. The use of sealed envelopes helps ensure that the treatment assignments are concealed until the last moment before the participant receives the treatment. This minimizes the risk of selection bias and ensures that the allocation process is not influenced by knowledge of upcoming assignments. The randomization process and envelope preparation are typically conducted by individuals who are not directly involved in participant enrollment or data collection to maintain the integrity of the study design, Blinding description: Single blinded.</study_design>
      <phase>2</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group (Resistance Exercise): Participants will engage in a supervised resistance exercise program. Patient- tailored program of resistance exercise will be applied. The program will include a moderate to progressive series of resistance exercises targeting major muscle groups. Sessions will be conducted 2 times per week for 6 weeks. Each session will last 45 minutes, including warm-up, exercise, and cool-down. Exercise intensity and resistance will be adjusted based on individual capabilities and progress. Participants' pain, fatigue, and muscle mass will be closely monitored throughout the intervention. Intervention 2: Control Group (Standard Care): Participants will receive standard care, including medical treatments and recommendations provided by their healthcare providers. No specific exercise interventions will be introduced during the study period for this group.</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:
Demographic data and data related to final outcome will be shared by maintaining the confidentiality

When:
Data will be available from November 2024 to December 2024 after the 6 months of publication. The data sharing plan for a clinical trial( i.e. what data will be shared when and under what conditions)will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's international clinical trail registry platform, this occur before the first participants is enrolled.

To whom:
Ayesha Javed( corresponding author) masters student at university of Lahore

Conditions:
For research purpose

Where to obtain:
To the corresponding author of the study, Dr. Ayesha Javed and can contact on +923006477662 ,ayeshajavedrao@gmail.com

How to obtain:
Open access and there is the traditional public data release where anyone can get access to the data  with no registration or conditions. The request will be reviewed by director in charge and in case  of eligibility, it would be shared in two weeks

Comments:
I want randomized clinical trial registration</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ayesha javed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no. 41, block C, Punjab government employees cooperative housing society, Phase 2, Lahore , Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54770</zip>
        <telephone>+92 313 8633199</telephone>
        <email>ayeshajavedrao@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ayesha javed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no. 41, block C, Punjab government employees cooperative housing society, Phase 2, Lahore , Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54770</zip>
        <telephone>+92 313 8633199</telephone>
        <email>ayeshajavedrao@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	Breast Cancer survivors
•	Cancer survivors undergoing pain and moderate fatigue
•	Cancer survivors had treatment with both chemotherapy and radiation therapies
•	Age between 18 to 50 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•	Recent orthopedic surgery.
•	Active infections in cancer patients of grade III-IV i.e sepsis.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group (Resistance Exercise): Participants will engage in a supervised resistance exercise program. Patient- tailored program of resistance exercise will be applied. The program will include a moderate to progressive series of resistance exercises targeting major muscle groups. Sessions will be conducted 2 times per week for 6 weeks. Each session will last 45 minutes, including warm-up, exercise, and cool-down. Exercise intensity and resistance will be adjusted based on individual capabilities and progress. Participants' pain, fatigue, and muscle mass will be closely monitored throughout the intervention.</i_keyword>
      <i_keyword>Control Group (Standard Care): Participants will receive standard care, including medical treatments and recommendations provided by their healthcare providers. No specific exercise interventions will be introduced during the study period for this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention ,3 and 6th weeks After intervention. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: Before intervention ,3 and 6th weeks after intervention. Method of measurement: Multidimensional fatigue inventory questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mobility. Timepoint: Before intervention, 3 and 6 weeks after intervention. Method of measurement: Timed Up and Go (TUG) test.</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>University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-16</approval_date>
        <contact_name>Research ethics committee of University of Lahore</contact_name>
        <contact_address>1-Km Defence Road, near Bhuptian Chowk, Lahore, Punjab Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
