<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/NCT02982980</url>
  </required_header>
  <id_info>
    <org_study_id>FUSaoPauloPT5</org_study_id>
    <nct_id>NCT02982980</nct_id>
  </id_info>
  <brief_title>Upper Limb Muscular Strengthening in the Rehabilitation of Patients Submitted to the Breast Cancer Surgical Treatment</brief_title>
  <official_title>Muscle Strength Exercises After Breast Cancer Surgery: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The presence of pain, reduced range of motion and decrease of muscle strength of the upper&#xD;
      limb in the early postoperative period are some of the major deficiencies of the breast&#xD;
      cancer patients.&#xD;
&#xD;
      The objectives of this study were to evaluate muscle strength, range of motion (ROM), pain,&#xD;
      perimetry of the upper limbs and applied questionnaires of the upper lim function and quality&#xD;
      of life, in patients after surgical treatment of breast cancer in different postoperative&#xD;
      periods and different groups following rehabilitation: traditional postoperatively exercise&#xD;
      to perform at home versus traditional exercises associated with weekly physiotherapy sessions&#xD;
      to strength training for shoulder movements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A clinical trial, randomized, blinded study. The groups were divided according to the type of&#xD;
      rehabilitation (weekly sessions of Physiotherapy-F and Orientation -O). The surgical type&#xD;
      (M-Mastectomy and Q-Quadrantectomy) was also taken into account.&#xD;
&#xD;
      Were not included in the study those patients who underwent previous surgeries of breast&#xD;
      cancer, breast reconstruction, those with some neurological deficit or acute orthopedic&#xD;
      shoulder injury, such as tendonitis or bursitis, patients with previous histories of shoulder&#xD;
      fracture with limited range of motion and tumor stage T4b or N3 or patients with bone or&#xD;
      brain metastases.&#xD;
&#xD;
      All patients underwent preoperative evaluation and guidance of general care; then returned&#xD;
      after one, two, three and six months postoperatively for reassessment and reorientation. The&#xD;
      physiotherapy group, in addition to receiving guidance, had, weekly, physical therapy&#xD;
      sessions with the goal to increase muscle strength in the upper limbs, between one and three&#xD;
      months after surgery.The exercises performed were active-free, with the aid of a stick or&#xD;
      resistance by elastic bands and dumbbells for flexion, extension, adduction, abduction,&#xD;
      external and internal rotation of the shoulder, and elbow flexion and extension, besides&#xD;
      activities to enable movements functional. The mode of execution of the exercises was&#xD;
      isotonic, done slowly and within the joint amplitude reached by the patient, using resistance&#xD;
      according to the muscular capacity of each patient.&#xD;
&#xD;
      All evaluations were performed by the physiotherapy team; the professionals were not aware of&#xD;
      whether the patient belonged to the physiotherapy group or to the guidance group, constituted&#xD;
      by a single evaluator (blinded study).&#xD;
&#xD;
      The evaluations were: muscular strength of the shoulder, evaluated by means of a manual&#xD;
      isokinetic dynamometer, which records the peak of force, in kilograms, during five seconds of&#xD;
      muscle contraction duration; range of motion of the shoulder: measured by a goniometer;&#xD;
      function of the upper limb: ascertained by the application of a specific questionnaire, the&#xD;
      Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) assesses functional capacity&#xD;
      in upper limb diseases and measures the abilities to perform certain activities; pain:&#xD;
      evaluated by the application of the Verbal Numerical Pain Scale (NVA); perimetry: evaluated&#xD;
      with a tape measure in eight distinct points in the upper limbs and quality of life, analyzed&#xD;
      by a European Organization for Research and Treatment of Cancer (EORTC) Quality of Life C30&#xD;
      (QLQ-C30) questionnaire with a Specific module for breast cancer (BR) 23 - Breast Specific&#xD;
      Module.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>two years</time_frame>
    <description>Muscle strength of shoulder movements with Hand Held Dynamometer model 01163, Lafayette Instrument Company.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>two years</time_frame>
    <description>Shoulder range of motion measured by a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper limb function</measure>
    <time_frame>two years</time_frame>
    <description>Upper limb function determined by the application of a specific questionnaire, the DASH (Disability of Arms, Shoulder and Hand Questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>two years</time_frame>
    <description>Pain: assessed by the application of the Verbal Numerical Pain Scale (VN)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perimeter</measure>
    <time_frame>two years</time_frame>
    <description>Perimeter: evaluated with a tape measure at eight distinct points in the upper limbs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>two years</time_frame>
    <description>Quality of life, analyzed by a questionnaire C30 (QLQ-C30) from the European Organization for Research and Treatment of Cancer (EORTC) Cancer, BR-23 (Breast Specific Module ).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Muscle Strength Quantitative Trait Locus 1</condition>
  <arm_group>
    <arm_group_label>Physiotherapy Guidance Mastectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who underwent radical breast surgery, received pre and postoperative assessment and orientation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phys Muscle strengthening Mastectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who underwent radical breast surgery, in addition to receiving guidance, had, weekly, physical therapy sessions with the goal to increase muscle strength in the upper limbs, between one and three months after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physiotherapy Guidance Quadrantectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who underwent partial breast surgery, received pre and postoperative assessment and orientation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phys Muscle strengthening Quadrantectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who underwent partial breast surgery, in addition to receiving guidance, had, weekly, physical therapy sessions with the goal to increase muscle strength in the upper limbs, between one and three months after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physiotherapy Guidance</intervention_name>
    <description>Pre and postoperative assessment and orientation, guidelines for lymphedema prevention and self drainage, follow-up for rehabilitation or maintenance of joint amplitude of shoulder movements and functional return.</description>
    <arm_group_label>Physiotherapy Guidance Mastectomy</arm_group_label>
    <arm_group_label>Physiotherapy Guidance Quadrantectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physiotherapy Muscle strengthening</intervention_name>
    <description>The exercises performed were active-free, with the aid of a stick or resistance by elastic bands and dumbbells for flexion, extension, adduction, abduction, external and internal rotation of the shoulder, and elbow flexion and extension, besides activities to enable movements Functional. The mode of execution of the exercises was isotonic, done slowly and within the joint amplitude reached by the patient, using resistance according to the muscular capacity of each patient.</description>
    <arm_group_label>Phys Muscle strengthening Mastectomy</arm_group_label>
    <arm_group_label>Phys Muscle strengthening Quadrantectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing radical or conservative surgical treatment of breast cancer&#xD;
&#xD;
          -  Patients who did some type of investigation of axillary lymph node involvement,&#xD;
             sentinel lymph node biopsy (BLS) or lymph node dissection (LND)&#xD;
&#xD;
          -  Patients who have performed the final and final evaluation&#xD;
&#xD;
          -  Patients in the Muscular Strength group, who have not missed more than 3 treatment&#xD;
             sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients submitted to a new breast surgical intervention during the total time of&#xD;
             follow-up of the research.&#xD;
&#xD;
          -  previous surgeries of breast cancer;&#xD;
&#xD;
          -  bilateral surgeries&#xD;
&#xD;
          -  immediate breast reconstruction&#xD;
&#xD;
          -  neurological deficit or acute orthopedic affection in the shoulder,&#xD;
&#xD;
          -  advanced tumor stage T4b or N3 or patients with bone or brain metastases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gil Facina, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Gil Facina</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02982980
org study id: FUSaoPauloPT5
nct id: NCT02982980
lead sponsor: 
has dmc: Yes
The presence of pain, reduced range of motion and decrease of muscle strength of the upper
      limb in the early postoperative period are some of the major deficiencies of the breast
      cancer patients.

      The objectives of this study were to evaluate muscle strength, range of motion (ROM), pain,
      perimetry of the upper limbs and applied questionnaires of the upper lim function and quality
      of life, in patients after surgical treatment of breast cancer in different postoperative
      periods and different groups following rehabilitation: traditional postoperatively exercise
      to perform at home versus traditional exercises associated with weekly physiotherapy sessions
      to strength training for shoulder movements.
A clinical trial, randomized, blinded study. The groups were divided according to the type of
      rehabilitation (weekly sessions of Physiotherapy-F and Orientation -O). The surgical type
      (M-Mastectomy and Q-Quadrantectomy) was also taken into account.

      Were not included in the study those patients who underwent previous surgeries of breast
      cancer, breast reconstruction, those with some neurological deficit or acute orthopedic
      shoulder injury, such as tendonitis or bursitis, patients with previous histories of shoulder
      fracture with limited range of motion and tumor stage T4b or N3 or patients with bone or
      brain metastases.

      All patients underwent preoperative evaluation and guidance of general care; then returned
      after one, two, three and six months postoperatively for reassessment and reorientation. The
      physiotherapy group, in addition to receiving guidance, had, weekly, physical therapy
      sessions with the goal to increase muscle strength in the upper limbs, between one and three
      months after surgery.The exercises performed were active-free, with the aid of a stick or
      resistance by elastic bands and dumbbells for flexion, extension, adduction, abduction,
      external and internal rotation of the shoulder, and elbow flexion and extension, besides
      activities to enable movements functional. The mode of execution of the exercises was
      isotonic, done slowly and within the joint amplitude reached by the patient, using resistance
      according to the muscular capacity of each patient.

      All evaluations were performed by the physiotherapy team; the professionals were not aware of
      whether the patient belonged to the physiotherapy group or to the guidance group, constituted
      by a single evaluator (blinded study).

      The evaluations were: muscular strength of the shoulder, evaluated by means of a manual
      isokinetic dynamometer, which records the peak of force, in kilograms, during five seconds of
      muscle contraction duration; range of motion of the shoulder: measured by a goniometer;
      function of the upper limb: ascertained by the application of a specific questionnaire, the
      Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) assesses functional capacity
      in upper limb diseases and measures the abilities to perform certain activities; pain:
      evaluated by the application of the Verbal Numerical Pain Scale (NVA); perimetry: evaluated
      with a tape measure in eight distinct points in the upper limbs and quality of life, analyzed
      by a European Organization for Research and Treatment of Cancer (EORTC) Quality of Life C30
      (QLQ-C30) questionnaire with a Specific module for breast cancer (BR) 23 - Breast Specific
      Module.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Muscle strength
time frame: two years
description: Muscle strength of shoulder movements with Hand Held Dynamometer model 01163, Lafayette Instrument Company.
measure: Range of motion
time frame: two years
description: Shoulder range of motion measured by a goniometer
measure: Upper limb function
time frame: two years
description: Upper limb function determined by the application of a specific questionnaire, the DASH (Disability of Arms, Shoulder and Hand Questionnaire)
measure: Pain
time frame: two years
description: Pain: assessed by the application of the Verbal Numerical Pain Scale (VN)
measure: Perimeter
time frame: two years
description: Perimeter: evaluated with a tape measure at eight distinct points in the upper limbs
measure: Quality of life
time frame: two years
description: Quality of life, analyzed by a questionnaire C30 (QLQ-C30) from the European Organization for Research and Treatment of Cancer (EORTC) Cancer, BR-23 (Breast Specific Module ).
arm group label: Physiotherapy Guidance Mastectomy
arm group type: Experimental
description: Patients who underwent radical breast surgery, received pre and postoperative assessment and orientation.
arm group label: Phys Muscle strengthening Mastectomy
arm group type: Experimental
description: Patients who underwent radical breast surgery, in addition to receiving guidance, had, weekly, physical therapy sessions with the goal to increase muscle strength in the upper limbs, between one and three months after surgery.
arm group label: Physiotherapy Guidance Quadrantectomy
arm group type: Experimental
description: Patients who underwent partial breast surgery, received pre and postoperative assessment and orientation.
arm group label: Phys Muscle strengthening Quadrantectomy
arm group type: Experimental
description: Patients who underwent partial breast surgery, in addition to receiving guidance, had, weekly, physical therapy sessions with the goal to increase muscle strength in the upper limbs, between one and three months after surgery.
intervention type: Procedure
intervention name: Physiotherapy Guidance
description: Pre and postoperative assessment and orientation, guidelines for lymphedema prevention and self drainage, follow-up for rehabilitation or maintenance of joint amplitude of shoulder movements and functional return.
arm group label: Physiotherapy Guidance Mastectomy
arm group label: Physiotherapy Guidance Quadrantectomy
intervention type: Procedure
intervention name: Physiotherapy Muscle strengthening
description: The exercises performed were active-free, with the aid of a stick or resistance by elastic bands and dumbbells for flexion, extension, adduction, abduction, external and internal rotation of the shoulder, and elbow flexion and extension, besides activities to enable movements Functional. The mode of execution of the exercises was isotonic, done slowly and within the joint amplitude reached by the patient, using resistance according to the muscular capacity of each patient.
arm group label: Phys Muscle strengthening Mastectomy
arm group label: Phys Muscle strengthening Quadrantectomy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gil Facina, PhD
role: Principal Investigator
affiliation: Federal University of São Paulo
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Gil Facina
investigator title: Doctor