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Clinical Trials/NCT02517086
NCT02517086UnknownNot Applicable

Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer

University of Sao Paulo0 sites3 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
3
Primary Endpoint
Doppler Ultrasound- velocity of blood flow

Study Overview

Brief Summary

The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer.

Detailed Description

With increasing survival of women treated for breast cancer, it becomes necessary to evaluate the effect of therapeutic resources in morbidity due to surgical treatment of breast cancer. The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer. The study will be conducted according to design random cross over and wash out period of 7 days. They will be evaluated 30 volunteers aged between 45 and 70 years, submitted to treatment of breast cancer. The volunteers will be submitted to three different therapeutic procedures applied randomly by lot: active exercises, functional compressive bandaging with active exercises and elastic compression with active exercises. The profile of blood flow, including speed and direction, will be assessed by Doppler ultrasound before and after, at 0, 15, 30 minutes. Normality will be verified by the Shapiro-Wilk test, and the effect of behavior between pre- and post-intervention will be evaluated by ANOVA two-way followed by post-hoc test Friedman followed rank, p <0.05 . The data obtained in the study are intended to enhance the forms of physical therapy intervention in the face of circulatory morbidities resulting from breast cancer treatments.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
Single (Investigator)

Eligibility Criteria

Ages
45 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •women diagnosed with breast cancer undergoing surgical treatment combined with axillary dissection or sentinel node biopsy
  • •diagnosed with moderate to severe unilateral lymphedema

Exclusion Criteria

  • •Women with muscle-tendon injury and / or joint damage in the -affected limb,
  • •skin disorders,
  • •diabetes,
  • •circulatory disease not controlled, -chemotherapy
  • •radiotherapy,
  • •diagnostic with metastasis in the upper limb
  • •women pregnancy.

Arms & Interventions

therapeutic exercises

Active Comparator

The applied therapeutic exercises involve shoulder movements including flexion, extension, abduction, adduction, internal and external rotation in isolated or combined movements, with ten repetitions of each movement, associated with the music, and stretching movements finalizing the sequence of movements.

Intervention: therapeutic exercises (Other)

elastic compression

Active Comparator

exercises for upper limb will be performed for an hour associated with the use of elastic compression. Elastic compression will be effected through a clamp brand compression of 30-40 mmHg according to the measures of voluntary member.

Intervention: elastic compression (Other)

functional compressive bandaging

Active Comparator

exercises for upper limb will be performed for an hour associated with the use of functional compressive bandaging. The functional compressive bandaging will be held with the volunteer sitting with ipsilateral upper limb resting on the support surgery. After hydration member a cotton mesh is used to prevent friction density 1cm strip of foam on the member to be wrapped. Elastic bandages of cotton will be involved 5 cm, 10 cm, 15 cm from the fingers to the axillary region multilayered

Intervention: functional compressive bandaging (Other)

Outcomes

Primary Outcomes

Doppler Ultrasound- velocity of blood flow

Time Frame: one day

Doppler ultrasound is used to measure the velocity of blood flow of the axillary and brachial vein of the upper limb with lymphedema

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elaine Caldeira de Oliveira Guirro

Monique Silva Rezende

University of Sao Paulo

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