<?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>IRCT20180511039615N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-02</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of pilates exercise in woman with breast cancer</public_title>
      <acronym>MBRCP</acronym>
      <scientific_title>The effect of pilates exercise on memory, attention and balance in woman with post mastectomy lymphedema, shahid motahari clinic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31283</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For sampling in this study, women with secondary lymphatic encephalomy following a modified radical mastectomy referring to the lymphatic clinic of Shahid Motahari clinic in Shiraz were selected based on their inclusion criteria and the purpose of the study. Then they were randomly selected Using random numbers, blocks are assigned to two groups by block method.
 First, the researcher creates the different permutations of A (representing the intervention group) and B (representing the control group), which consists of 6 different modes. For example, BABA-6, ...., ABAB-2, AABB-1). Then, to select the sample individuals from the table, move your finger randomly from a random point table in the direction of a row or column. If the number is between one and six, the permutation of that number is noted. For example, if the number 6 comes, we will record ABAB permutations, and thus eligible patients will be in the control group and in the intervention group (Pilates training group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of Pilates exercises on memory, attention and balance of women suffering from lumbar edema after mastectomy at Shahid Motahari Clinic.</hc_freetext>
      <i_freetext>Intervention 1: This study included a control group and an intervention group. The intervention in this study is Pilates exercise for 4 weeks, 3 sessions for the intervention group for one hour in the training room and under the supervision of trained person.  According to this protocol, the training consists of two blocks per day, with each block consisting of 3 exercises of dedicated warm-up, prerequisite and level two pilates. Pilates respiratory exercises have also been selected in these exercises with regard to their role in chest expansion, maximizing the range of neck, shoulder, elbow movements, ultimately maximizing elongation in the skin and activating the muscles around the armpit and lymph nodes. . Balanced exercises have also been selected to raise the balance of these individuals. In the present study, in order to get acquainted with the fellow patients in the educational intervention group, the benefits of Pilates exercises are presented on the entire body structure. It should be noted that besides the intervention described, both intervention and control groups will use standard deactivation treatment according to the clinical guidelines. After 2 weeks of Pilates training, we reach the T1 point in which we will remeasure the attention , Memory and balance for the participants in the intervention and control group and the patient's treatment process continues for 2 weeks, as in the past (from the start of the study in the same groups). At the end of the fourth week, from the moment of entering the study, the samples reach the T2 point, at which time the patient's attention, memory and balance will be measured again as a post-test. In the final stage, the data set will be analyzed by statistical tests. Considering the use of Pilates as a therapeutic and rehabilitation method in this study, the collaboration of Pilates specialists will be used to confirm the validity of the movements. Intervention 2: Control group: In this research control group does not do any exercise. And they only do pre-tests and post-tests of memory, balance and attention tests.  It should be noted that besides the intervention described, both intervention and control groups will use standard deactivation treatment according to the clinical guidelines. After 2 weeks of Pilates training, we reach the T1 point in which we will remeasure the attention , Memory and balance for the participants in the intervention and control group and the patient's treatment process continues for 2 weeks, as in the past (from the start of the study in the same groups). At the end of the fourth week, from the moment of entering the study, the samples reach the T2 point, at which time the patient's attention, memory and balance will be measured again as a post-test. In the final stage, the data set will be analyzed by statistical tests.</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>Robabeh Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 52, Ava Building, Alleyway No. 27, Mali Abad Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7187711659</zip>
        <telephone>+98 71 3634 2470</telephone>
        <email>z.shenasa@shirazu.ac.ir</email>
        <affiliation>Shiraz university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Robabeh Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 52, Ava Building, Alleyway No. 27, Mali Abad Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7187711659</zip>
        <telephone>+98 71 3634 2470</telephone>
        <email>z.shenasa@shirazu.ac.ir</email>
        <affiliation>Shiraz university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire to participate in the research
Having the ability to communicate verbally
Women with secondary upper limb edema following mastectomy
Ability to move independently
At least one year of mastectomy surgery</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to cooperate
Exacerbation of illness or hospitalization
Congestive heart failure or chronic obstructive pulmonary disease
Patients under chemotherapy or radiation therapy
Having a pacemaker heart
Pregnancy</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study included a control group and an intervention group. The intervention in this study is Pilates exercise for 4 weeks, 3 sessions for the intervention group for one hour in the training room and under the supervision of trained person.  According to this protocol, the training consists of two blocks per day, with each block consisting of 3 exercises of dedicated warm-up, prerequisite and level two pilates. Pilates respiratory exercises have also been selected in these exercises with regard to their role in chest expansion, maximizing the range of neck, shoulder, elbow movements, ultimately maximizing elongation in the skin and activating the muscles around the armpit and lymph nodes. . Balanced exercises have also been selected to raise the balance of these individuals. In the present study, in order to get acquainted with the fellow patients in the educational intervention group, the benefits of Pilates exercises are presented on the entire body structure. It should be noted that besides the intervention described, both intervention and control groups will use standard deactivation treatment according to the clinical guidelines. After 2 weeks of Pilates training, we reach the T1 point in which we will remeasure the attention , Memory and balance for the participants in the intervention and control group and the patient's treatment process continues for 2 weeks, as in the past (from the start of the study in the same groups). At the end of the fourth week, from the moment of entering the study, the samples reach the T2 point, at which time the patient's attention, memory and balance will be measured again as a post-test. In the final stage, the data set will be analyzed by statistical tests. Considering the use of Pilates as a therapeutic and rehabilitation method in this study, the collaboration of Pilates specialists will be used to confirm the validity of the movements</i_keyword>
      <i_keyword>Control group: In this research control group does not do any exercise. And they only do pre-tests and post-tests of memory, balance and attention tests.  It should be noted that besides the intervention described, both intervention and control groups will use standard deactivation treatment according to the clinical guidelines. After 2 weeks of Pilates training, we reach the T1 point in which we will remeasure the attention , Memory and balance for the participants in the intervention and control group and the patient's treatment process continues for 2 weeks, as in the past (from the start of the study in the same groups). At the end of the fourth week, from the moment of entering the study, the samples reach the T2 point, at which time the patient's attention, memory and balance will be measured again as a post-test. In the final stage, the data set will be analyzed by statistical tests.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring patient balance. Timepoint: The patient's balance is measured one week before the start of the workout and one week after the exercise. Method of measurement: This research is intended to measure the balance of scores obtained by a single-leg stand test.</prim_outcome>
      <prim_outcome>Measure the attention of patients. Timepoint: The time to measure patients' attention is one week before the beginning of the workout and one week after the workout. Method of measurement: The score will be estimated by the Stroop test.</prim_outcome>
      <prim_outcome>Measuring patient memory. Timepoint: The time to measure patients' memory is one week before the start of the workout and one week after the workout. Method of measurement: The score of people's memory will be estimated through the N-Back test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-14</approval_date>
        <contact_name>Ethics Committee of Shiraz University.</contact_name>
        <contact_address>Unit 52, Ava Building, Alleyway No. 27, Mali Abad Street shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
