The 24 Hour Effects of Remedial Exercises With and Without Compression Therapy on Breast Cancer-related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Circumference measurement
研究概览
简要总结
The aim of this study to investigate 24 hours of effects of remedial exercises with and without compression therapy on severity of lymphedema and symptoms of the lymphedema The present study is designed as a non-drug clinical trial. The patients will complete two remedial exercise sessions, one without and one with compression in a randomized order separated by a 3-day wash-out period.The main questions it aims to answer are
- The 24 hour effects of remedial exercises with and without compression therapy on the severity of lymphedema are different in individuals with lymphedema associated with breast cancer surgery.
- The 24 hour effects of remedial exercises with and without compression therapy on the symptoms of lymphedema are different in individuals with lymphedema associated with breast cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of unilateral arm lymphedema related to breast cancer disease- Age between 18 and 75 years
- •2 cm or greater difference between the affected and unaffected arms in women with breast cancer related lymphedema
- •At least 12 months after breast cancer surgery end
排除标准
- •current recurrence of breast cancer
- •bilateral involvement
- •active infection
- •presence of metastases
- •diabetes mellitus
- •hypertension
- •pre-existing neuromusculoskeletal and neurological conditions
- •edema due to other reasons (e.g., primary lymphedema, lung and heart diseases)
结局指标
主要结局
Circumference measurement
时间窗: Change in symptoms related to lymphedema from baseline up to end of 24 hour
The severity of lymphedema between the two extremities will be measured by measuring the environment at 5 cm intervals.
Bioimpedance spectroscopy
时间窗: Change in symptoms related to lymphedema from baseline up to end of 24 hour
The patient is in the supine position with his arms and legs not touching each other. This measurement will be made using the Impedimed L-Dex U 400 device. The reference point is the top of both hands and the dorsum of the foot. This measurement is made using superficial electrodes and there is no risk. The percentage of fluid will be calculated by making a measurement for both arms.
Ultrasonographic measurements
时间窗: Change in symptoms related to lymphedema from baseline up to end of 24 hour
Ultrasound imaging was performed using a 5-13-Megahertz linear probe. During the procedure, the participants will be seated with their forearms supinated and extended on a pillow. Measurements will be made bilaterally from 10 cm distal and proximal to the elbow bend, from the midpoint of the medial and lateral epicondyles, along the line parallel to the arm axis.
次要结局
- symptoms of lymphedema(Change in symptoms related to lymphedema from baseline up to end of 24 hour)
研究者
Turkan Akbayrak
Prof. Dr.
Hacettepe University