Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer
2015年8月3日 更新者:Elaine Caldeira de Oliveira Guirro、University of Sao Paulo
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.
研究概览
地位
未知
详细说明
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.
研究类型
介入性
注册 (预期的)
3
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:therapeutic exercises
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.
|
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.
|
|
有源比较器:elastic compression
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.
|
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.
|
|
有源比较器:functional compressive bandaging
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
|
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
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Doppler Ultrasound- velocity of blood flow
大体时间: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
|
one day
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Elaine Guirro、University of Sao Paulo- Ribeirao Preto- Brazil
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年8月1日
初级完成 (实际的)
2015年8月1日
研究完成 (预期的)
2016年7月1日
研究注册日期
首次提交
2015年6月10日
首先提交符合 QC 标准的
2015年8月3日
首次发布 (估计)
2015年8月6日
研究记录更新
最后更新发布 (估计)
2015年8月6日
上次提交的符合 QC 标准的更新
2015年8月3日
最后验证
2015年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.