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Completed

NCT Number: NCT02574780

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Brazil Federal University São Paulo

São Paulo, 04020-060, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

complex physical therapy

Other

Compare the standard treatment of lymphedema, by complex physical therapy versus TFC associated with the upper limbs strengthening exercises.

Evaluate treatment of lymphedema, with in the quality of life and depression

Other

evaluate through the questionnaires fatigue and quality of life of patients with lymphedema (FACT- F and Inventory BECK)

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Lymphedema Treatment of Post-surgical Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy

Acronym: LTP

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 14, 2015
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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