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临床试验/NCT02517086
NCT02517086Unknown不适用

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

University of Sao Paulo0 个研究点目标入组 3 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
3
主要终点
Doppler Ultrasound- velocity of blood flow

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (Investigator)

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Doppler Ultrasound- velocity of blood flow

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elaine Caldeira de Oliveira Guirro

Monique Silva Rezende

University of Sao Paulo

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