<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/NCT02215668</url>
  </required_header>
  <id_info>
    <org_study_id>313.907</org_study_id>
    <nct_id>NCT02215668</nct_id>
  </id_info>
  <brief_title>The Effect of Physical Exercise in Reducing Pain in Women Undergoing Mammography</brief_title>
  <official_title>Impact of Physical Exercise, Aimed at Reducing Pain in Women Who Underwent Mammography.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mammography is a systematic way in the main programs of screening for breast cancer in women&#xD;
      over 40 or 50 years old, according to screening programs, but most research has shown a&#xD;
      frequency of discomfort and pain during the examination mammography. This study is a&#xD;
      randomized controlled trial, whose intervention will be a sequence of exercises body warming&#xD;
      and muscle stretching, performed systematic manner and supervised by a physical educator. It&#xD;
      is expected to find in this study a possible impact of physical exercise in reducing pain&#xD;
      after mammography examination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research aims to evaluate the relationship of pre-mammography guided physical activity&#xD;
      and pain after the examination, evaluating the impact of the intervention in a group of&#xD;
      patients undergoing upper limb exercise (SLE), compared to another group women not subject&#xD;
      exposure (MNE), and another group with lower limb exercise (LLE). This study is a randomized&#xD;
      controlled trial, whose intervention will be a sequence of exercises body warming and muscle&#xD;
      stretching, performed systematic manner and supervised by a physical educator. It is expected&#xD;
      to find in this study a possible impact of physical exercise in reducing pain after&#xD;
      mammography examination. The results will be checked by study association between the level&#xD;
      of physical activity, body mass index, breast density and reducing the pain effect between&#xD;
      groups for comparison of means and variances of values of the visual analogue scale (VAS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decreased pain after mammography.</measure>
    <time_frame>Decrease in pain after performing mammography, checked10 minutes after the procedure e, measured by visual analog scale.</time_frame>
    <description>Following the randomization, approximately 10 minutes after performing a physical exercise in the upper limbs (Group 1) and lower (Group 2), or not performing any physical exercise (Group 0), the woman will be submitted to bilateral mammogram. Ten minutes after the procedure, the assessment of pain during mammography will be measured by the visual analog scale. The mean difference between the measurements of visual analog scale (VAS) will be compared between groups.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">198</enrollment>
  <condition>Pain</condition>
  <condition>Side Effects</condition>
  <arm_group>
    <arm_group_label>No physical exercise</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women are never subjected to any exercise prior to mammography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical exercise (Upper limb)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will be subjected to physical exercise on upper limb prior to mammography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women are subjected to physical exercise in the lower limbs prior to mammography</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physical exercise</intervention_name>
    <description>Exercise muscle stretching and body warming.</description>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Physical exercise (Upper limb)</arm_group_label>
    <other_name>Physical activity</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women: 20 to 69 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Mental diseases&#xD;
&#xD;
          -  Pulmonary diseases&#xD;
&#xD;
          -  Steroids use&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Altacilio A Nunes, MD; Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ribeirao Preto Medical School - USP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Altacilio A Nunes, Ph.D</last_name>
    <phone>+551636022884</phone>
    <email>altacilio@fmrp.usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tadeu Cardoso, MSc</last_name>
    <phone>+5517981132313</phone>
    <email>tadeucardoso@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital do Cancer de Barretos</name>
      <address>
        <city>Barretos</city>
        <state>Sao Paulo</state>
        <zip>14780000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Altacilio A Nunes, MD; Ph,D</last_name>
      <phone>+551636022884</phone>
      <email>altacilio@fmrp.usp.br</email>
    </contact>
    <contact_backup>
      <last_name>Tadeu</last_name>
    </contact_backup>
    <investigator>
      <last_name>Tadeu Cardoso, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Altacílio Aparecido Nunes</investigator_full_name>
    <investigator_title>Full professor; MD; Ph.D.</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>December 21, 2015</submitted>
    <returned>February 1, 2016</returned>
    <submitted>February 1, 2016</submitted>
    <returned>February 29, 2016</returned>
    <submitted>May 10, 2016</submitted>
    <returned>June 16, 2016</returned>
    <submitted>June 20, 2016</submitted>
    <returned>July 29, 2016</returned>
    <submitted>August 2, 2016</submitted>
    <returned>September 23, 2016</returned>
  </pending_results>
  <!-- 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/NCT02215668
org study id: 313.907
nct id: NCT02215668
lead sponsor: 
has dmc: Yes
Mammography is a systematic way in the main programs of screening for breast cancer in women
      over 40 or 50 years old, according to screening programs, but most research has shown a
      frequency of discomfort and pain during the examination mammography. This study is a
      randomized controlled trial, whose intervention will be a sequence of exercises body warming
      and muscle stretching, performed systematic manner and supervised by a physical educator. It
      is expected to find in this study a possible impact of physical exercise in reducing pain
      after mammography examination.
This research aims to evaluate the relationship of pre-mammography guided physical activity
      and pain after the examination, evaluating the impact of the intervention in a group of
      patients undergoing upper limb exercise (SLE), compared to another group women not subject
      exposure (MNE), and another group with lower limb exercise (LLE). This study is a randomized
      controlled trial, whose intervention will be a sequence of exercises body warming and muscle
      stretching, performed systematic manner and supervised by a physical educator. It is expected
      to find in this study a possible impact of physical exercise in reducing pain after
      mammography examination. The results will be checked by study association between the level
      of physical activity, body mass index, breast density and reducing the pain effect between
      groups for comparison of means and variances of values of the visual analogue scale (VAS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Decreased pain after mammography.
time frame: Decrease in pain after performing mammography, checked10 minutes after the procedure e, measured by visual analog scale.
description: Following the randomization, approximately 10 minutes after performing a physical exercise in the upper limbs (Group 1) and lower (Group 2), or not performing any physical exercise (Group 0), the woman will be submitted to bilateral mammogram. Ten minutes after the procedure, the assessment of pain during mammography will be measured by the visual analog scale. The mean difference between the measurements of visual analog scale (VAS) will be compared between groups.
arm group label: No physical exercise
arm group type: No Intervention
description: Women are never subjected to any exercise prior to mammography.
arm group label: Physical exercise (Upper limb)
arm group type: Experimental
description: Women will be subjected to physical exercise on upper limb prior to mammography.
arm group label: Group 2
arm group type: Active Comparator
description: Women are subjected to physical exercise in the lower limbs prior to mammography
intervention type: Procedure
intervention name: Physical exercise
description: Exercise muscle stretching and body warming.
arm group label: Group 2
arm group label: Physical exercise (Upper limb)
other name: Physical activity
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 69 Years
healthy volunteers: No
last name: Altacilio A Nunes, MD; Ph.D
role: Principal Investigator
affiliation: Ribeirao Preto Medical School - USP
last name: Altacilio A Nunes, Ph.D
phone: +551636022884
email: altacilio@fmrp.usp.br
last name: Tadeu Cardoso, MSc
phone: +5517981132313
email: tadeucardoso@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Altacílio Aparecido Nunes
investigator title: Full professor; MD; Ph.D.
submitted: December 21, 2015
returned: February 1, 2016
submitted: February 1, 2016
returned: February 29, 2016
submitted: May 10, 2016
returned: June 16, 2016
submitted: June 20, 2016
returned: July 29, 2016
submitted: August 2, 2016
returned: September 23, 2016