Lymphedema Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy (LTP)
Primary Purpose
Lymphedema
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
complex physical therapy
Evaluate treatment of lymphedema, with in the quality of life and depression
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema focused on measuring lymphedema, complex physical therapy, muscle strength
Eligibility Criteria
Inclusion Criteria:
- With lymphedema resulting from postoperative unilateral breast cancer
- difference in circumference between the upper limbs
Exclusion Criteria:
- Patients with bilateral breast cancer
- Grade IV lymphoedema called elephantiasis
- renal dysfunction
- treatment involving the reduction of lymphedema in the last three months; acute inflammation ; deep vein thrombosis ; heart disease; skin infections and disease locoregional or distant active base.
Sites / Locations
- Brazil Federal University São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Grupo I TFC
Grupo II TFC X PFM
Arm Description
Women with lymphedema , perform complex physical therapy with manual lymphatic drainage, compression bandaging and exercises linfomiocinéticos.
Standard treatment for lymphedema perform complex physical therapy associated with a muscular strength protocol.Muscle-building arm with load
Outcomes
Primary Outcome Measures
Result of complex physical therapy associated with muscle strength protocol
Brawn average difference between the upper limbs with and without lymphedema.
Secondary Outcome Measures
Full Information
NCT ID
NCT02574780
First Posted
October 9, 2015
Last Updated
October 7, 2016
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02574780
Brief Title
Lymphedema Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy
Acronym
LTP
Official Title
Lymphedema Treatment of Post-surgical Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The stage and lymphedema size can be detrimental to the quality of life and health of women, because the increase in circumference and member of the weight causes limitations in activities. Previous studies have shown that patients with lymphedema should not perform high intensity exercises, these exercises would cause the increase of lymphedema. Already, in current studies show that muscle strength exercises when properly applied, with controlled intensity and time, can help to reduce lymphedema. Thus, the main objective of this study is to compare the standard treatment of lymphedema through complex physical therapy versus the application of strengthening exercises for upper limbs together with complex physical therapy. The study design is a randomized controlled clinical trial. Participate in the study 50 patients, who will be allocated into two groups, group 1 (n = 25): Complex Physical Therapy; Group 2 (n = 25): Complex physical therapy in an exercise protocol, which will receive treatment twice a week for eight weeks. All patients will receive treatment and will be informed of the free and informed consent form at the beginning of the research. They will be met: the report cards, dynamometer testing and filling out questionnaires at the beginning and end of the study.
Detailed Description
This study will be conducted in Onco Mastology clinic of the Department of Mastology the Department of Gynecology, Federal University of São Paulo (UNIFESP) - Paulista School of Medicine (EPM), in which patients will be recruited, selected and informed about the study objectives , its relevance, activities to be developed and the possibility of improvement and remedy your questions and concerns about the disease.The study design is a randomized controlled clinical trial. To define the treatment, 50 patients are allocated to two groups, group 1 (n = 25) Group 2 (n = 25) that receive treatment twice a week for eight weeks. Physical examination will be performed, completing the consent form, evaluation form, and questionnaires. Group 1 standard treatment : 25 women with lymphedema , perform complex physical therapy with manual lymphatic drainage, compression bandaging and exercises linfomiocinéticos . Treatment was given twice a week , 8 consecutive weeks , 6 sessions.Group 2 standard treatment + muscle strength : 25 women with lymphedema , perform complex physical therapy, manual lymphatic drainage, compression bandaging and linfomiocinéticos exercises and strengthening exercises with load.Treatment was given twice a week , 8 consecutive weeks , 16 sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
lymphedema, complex physical therapy, muscle strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Grupo I TFC
Arm Type
Experimental
Arm Description
Women with lymphedema , perform complex physical therapy with manual lymphatic drainage, compression bandaging and exercises linfomiocinéticos.
Arm Title
Grupo II TFC X PFM
Arm Type
Experimental
Arm Description
Standard treatment for lymphedema perform complex physical therapy associated with a muscular strength protocol.Muscle-building arm with load
Intervention Type
Other
Intervention Name(s)
complex physical therapy
Intervention Description
Compare the standard treatment of lymphedema, by complex physical therapy versus TFC associated with the upper limbs strengthening exercises.
Intervention Type
Other
Intervention Name(s)
Evaluate treatment of lymphedema, with in the quality of life and depression
Intervention Description
evaluate through the questionnaires fatigue and quality of life of patients with lymphedema (FACT- F and Inventory BECK)
Primary Outcome Measure Information:
Title
Result of complex physical therapy associated with muscle strength protocol
Description
Brawn average difference between the upper limbs with and without lymphedema.
Time Frame
two years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
With lymphedema resulting from postoperative unilateral breast cancer
difference in circumference between the upper limbs
Exclusion Criteria:
Patients with bilateral breast cancer
Grade IV lymphoedema called elephantiasis
renal dysfunction
treatment involving the reduction of lymphedema in the last three months; acute inflammation ; deep vein thrombosis ; heart disease; skin infections and disease locoregional or distant active base.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil Facina
Organizational Affiliation
BRazil:Research committee - Recruting
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brazil Federal University São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04020-060
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lymphedema Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy
We'll reach out to this number within 24 hrs