Lymphedema Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy

Phase 2

Completed

• Conditions: Lymphedema
• Interventions: Other: complex physical therapy; Other: Evaluate treatment of lymphedema, with in the quality of life and depression

• Registration Number: NCT02574780
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-10
• Study First Posted: 2015-10-14
• Primary Completion: 2015-12
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grupo I TFC	Evaluate treatment of lymphedema, with in the quality of life and depression	Women with lymphedema , perform complex physical therapy with manual lymphatic drainage, compression bandaging and exercises linfomiocinéticos.
Grupo II TFC X PFM	Evaluate treatment of lymphedema, with in the quality of life and depression	Standard treatment for lymphedema perform complex physical therapy associated with a muscular strength protocol.Muscle-building arm with load
Grupo I TFC	complex physical therapy	Women with lymphedema , perform complex physical therapy with manual lymphatic drainage, compression bandaging and exercises linfomiocinéticos.
Grupo II TFC X PFM	complex physical therapy	Standard treatment for lymphedema perform complex physical therapy associated with a muscular strength protocol.Muscle-building arm with load

Primary Outcome Measures

Name	Time	Method
Result of complex physical therapy associated with muscle strength protocol	two years	Brawn average difference between the upper limbs with and without lymphedema.

Trial Locations

Locations (1)

Brazil Federal University São Paulo; 🇧🇷 São Paulo, SP, Brazil