Back to resultsDomiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation
Primary Purpose
Frozen Shoulder,, Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
evaluations
Protocol of physiotherapy exercises
Sponsored by
About this trial
This is an interventional prevention trial for Frozen Shoulder, focused on measuring breast cancer,, radiotherapy,, physical therapy,, upper limb
Eligibility Criteria
Inclusion Criteria:
- be diagnosed with unilateral breast cancer;
- be submitted to surgical and radiation treatment as part of the treatment for breast cancer.
Exclusion Criteria:
- patients with neurological or orthopedic diseases that could impair the upper limb movements
- bilateral breast cancer;
- prior thoracic radiotherapy;
- presence of distant metastasis.
Sites / Locations
- Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control Group (CG)
Study Group (SG)
Arm Description
Control Group, which were subjected only to evaluations and to no exercise
Study group (SG), was oriented to perform domiciliary exercises for the upper limbs.
Outcomes
Primary Outcome Measures
Recovery of shoulder range of movements (ROM) and prevention of arm lymphedema
Secondary Outcome Measures
Full Information
NCT ID
NCT01940107
First Posted
September 6, 2013
Last Updated
September 10, 2013
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01940107
Brief Title
Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation
Official Title
Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
5. Study Description
Brief Summary
To observe the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was significant difference between the ipsilateral and contralateral limbs for flexion, abduction and external rotation. There was no difference in perimetry in either group
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder,, Shoulder Pain
Keywords
breast cancer,, radiotherapy,, physical therapy,, upper limb
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group (CG)
Arm Type
Other
Arm Description
Control Group, which were subjected only to evaluations and to no exercise
Arm Title
Study Group (SG)
Arm Type
Experimental
Arm Description
Study group (SG), was oriented to perform domiciliary exercises for the upper limbs.
Intervention Type
Other
Intervention Name(s)
evaluations
Intervention Description
Only evaluations
Intervention Type
Procedure
Intervention Name(s)
Protocol of physiotherapy exercises
Intervention Description
Oriented domiciliary physiotherapeutic exercises
Primary Outcome Measure Information:
Title
Recovery of shoulder range of movements (ROM) and prevention of arm lymphedema
Time Frame
90 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
be diagnosed with unilateral breast cancer;
be submitted to surgical and radiation treatment as part of the treatment for breast cancer.
Exclusion Criteria:
patients with neurological or orthopedic diseases that could impair the upper limb movements
bilateral breast cancer;
prior thoracic radiotherapy;
presence of distant metastasis.
Facility Information:
Facility Name
Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
City
Ribeirão Preto
State/Province
Saõ Paulo
ZIP/Postal Code
14049900
Country
Brazil
12. IPD Sharing Statement
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Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation
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