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

NCT02574780 | Completed Phase 2 DMC

• 1 other identifier: FUSaoPaulo,PT 1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Keywords

lymphedema; complex physical therapy; muscle strength

Outcome Measures

Primary Outcomes (1)

• Result of complex physical therapy associated with muscle strength protocol

  Brawn average difference between the upper limbs with and without lymphedema.

  two years

Study Arms (2)

Grupo I TFC

EXPERIMENTAL

Women with lymphedema , perform complex physical therapy with manual lymphatic drainage, compression bandaging and exercises linfomiocinéticos.

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

Grupo II TFC X PFM

EXPERIMENTAL

Standard treatment for lymphedema perform complex physical therapy associated with a muscular strength protocol.Muscle-building arm with load

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

Interventions

complex physical therapy OTHER

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

Grupo I TFC; Grupo II TFC X PFM

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)

Grupo I TFC; Grupo II TFC X PFM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With lymphedema resulting from postoperative unilateral breast cancer
• difference in circumference between the upper limbs

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Brazil Federal University São Paulo

São Paulo, São Paulo, 04020-060, Brazil

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Gil Facina

  BRazil:Research committee - Recruting

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor clinical

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 14, 2015
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: October 10, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)