<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03826979</url>
  </required_header>
  <id_info>
    <org_study_id>2.510.081</org_study_id>
    <nct_id>NCT03826979</nct_id>
  </id_info>
  <brief_title>PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY</brief_title>
  <official_title>PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY OF THE MASTECTOMIZED WOMEN</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Metodista de Piracicaba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Metodista de Piracicaba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      INTRODUCTION: Breast cancer is one of the pathologies affecting women worldwide, with a high&#xD;
      mortality rate of 14,206 per 100,000 women per year. However, Pilates was used as a&#xD;
      therapeutic treatment for women who underwent a modified radical mastectomy, being associated&#xD;
      with the alterations when in the postoperative sequels.&#xD;
&#xD;
      OBJECTIVE: to evaluate the Pilates Method in the functionality of women submitted to modified&#xD;
      radical mastectomy.&#xD;
&#xD;
      METHOD: This is a quantitative clinical trial, in the form of women included in the project,&#xD;
      to undergo a physical therapy rehabilitation program through the Pilates Method for 2 months,&#xD;
      where they were evaluated before and after the procedure for measurement and comparison&#xD;
      obtained.&#xD;
&#xD;
      CONCLUSION: In this way, the pilates method is presented as an instrument used for the&#xD;
      rehabilitation of mastectomized women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>2 months</time_frame>
    <description>Medical Research Council scale for muscle power</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion</measure>
    <time_frame>2 months</time_frame>
    <description>Range of motion evaluation by goniometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functionality assess with Functional independence measure scale</measure>
    <time_frame>2 months</time_frame>
    <description>Functional independence measure scale</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Breast Neoplasm Female</condition>
  <arm_group>
    <arm_group_label>Pilates treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pliates method treatment</intervention_name>
    <description>The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months.</description>
    <arm_group_label>Pilates treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female subjects, between 30 and 65 years, with a diagnosis of breast cancer, who&#xD;
             underwent radical-mastectomy surgery and who had after 30 postoperative days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who present alterations in healing, severe pain, who have another type of&#xD;
             treatment, people who lack more than three times in the research, quitters, people&#xD;
             with relapses and who do not tolerate the treatment protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women in post-operative radical-mastectomy treatment.</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Raphael Pereira</name>
      <address>
        <city>Belém</city>
        <state>PA</state>
        <zip>66060-585</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Metodista de Piracicaba</investigator_affiliation>
    <investigator_full_name>Raphael do Nascimento Pereira</investigator_full_name>
    <investigator_title>Raphael do Nascimento Pereira</investigator_title>
  </responsible_party>
  <keyword>Breast cancer.</keyword>
  <keyword>Exercise Therapy</keyword>
  <keyword>Modified Radical Mastectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03826979
org study id: 2.510.081
nct id: NCT03826979
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
INTRODUCTION: Breast cancer is one of the pathologies affecting women worldwide, with a high
      mortality rate of 14,206 per 100,000 women per year. However, Pilates was used as a
      therapeutic treatment for women who underwent a modified radical mastectomy, being associated
      with the alterations when in the postoperative sequels.

      OBJECTIVE: to evaluate the Pilates Method in the functionality of women submitted to modified
      radical mastectomy.

      METHOD: This is a quantitative clinical trial, in the form of women included in the project,
      to undergo a physical therapy rehabilitation program through the Pilates Method for 2 months,
      where they were evaluated before and after the procedure for measurement and comparison
      obtained.

      CONCLUSION: In this way, the pilates method is presented as an instrument used for the
      rehabilitation of mastectomized women.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months
primary purpose: Treatment
masking: None (Open Label)
measure: Muscle strength
time frame: 2 months
description: Medical Research Council scale for muscle power
measure: Range of motion
time frame: 2 months
description: Range of motion evaluation by goniometry
measure: Functionality assess with Functional independence measure scale
time frame: 2 months
description: Functional independence measure scale
arm group label: Pilates treatment
arm group type: Experimental
description: The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months.
intervention type: Other
intervention name: Pliates method treatment
description: The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months.
arm group label: Pilates treatment
criteria: 
gender: Female
gender based: Yes
gender description: women in post-operative radical-mastectomy treatment.
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Metodista de Piracicaba
investigator full name: Raphael do Nascimento Pereira
investigator title: Raphael do Nascimento Pereira
mesh term: Breast Neoplasms
sharing ipd: Undecided