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Trial record 1 of 289 for:    Lymphedema
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Lymphedema Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy (LTP)

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ClinicalTrials.gov Identifier: NCT02574780
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Gil Facina, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Lymphedema Other: complex physical therapy Other: Evaluate treatment of lymphedema, with in the quality of life and depression Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lymphedema Treatment of Post-surgical Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy
Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 2016

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Arm Intervention/treatment
Experimental: Grupo I TFC
Women with lymphedema , perform complex physical therapy with manual lymphatic drainage, compression bandaging and exercises linfomiocinéticos.
Other: complex physical therapy
Compare the standard treatment of lymphedema, by complex physical therapy versus TFC associated with the upper limbs strengthening exercises.

Other: Evaluate treatment of lymphedema, with in the quality of life and depression
evaluate through the questionnaires fatigue and quality of life of patients with lymphedema (FACT- F and Inventory BECK)

Experimental: Grupo II TFC X PFM
Standard treatment for lymphedema perform complex physical therapy associated with a muscular strength protocol.Muscle-building arm with load
Other: complex physical therapy
Compare the standard treatment of lymphedema, by complex physical therapy versus TFC associated with the upper limbs strengthening exercises.

Other: Evaluate treatment of lymphedema, with in the quality of life and depression
evaluate through the questionnaires fatigue and quality of life of patients with lymphedema (FACT- F and Inventory BECK)




Primary Outcome Measures :
  1. Result of complex physical therapy associated with muscle strength protocol [ Time Frame: two years ]
    Brawn average difference between the upper limbs with and without lymphedema.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574780


Locations
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Brazil
Brazil Federal University São Paulo
São Paulo, SP, Brazil, 04020-060
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Gil Facina BRazil:Research committee - Recruting

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Responsible Party: Gil Facina, Doctor clinical, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02574780     History of Changes
Other Study ID Numbers: FUSaoPaulo,PT 1
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gil Facina, Federal University of São Paulo:
lymphedema
complex physical therapy
muscle strength

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases