Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention
Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial
Surgical treatments can cause late effects influencing activity of daily living, physical activity, and overall health. Late effects include persistent pain reported by 30 - 50% of women that underwent breast operations, restrictions of arm and shoulder movement were reported in 35% of patients, lymphedema in 15 - 25% of women who undergo axillary lymph node dissection and in about 6% of women who undergo sentinel lymph node biopsy. Lymphedema results in physical impairments including compromised function, diminished strength, fatigue, and pain in the affected arm . The axillary web syndrome is a self-limiting and frequently overlooked cause of significant morbidity in the early postoperative period after breast cancer, which is characterized by axillary pain that runs down the medial arm, limited shoulder range of motion (ROM) .
Physiotherapy and exercise in the postoperative period can result in a significant improvement in shoulder ROM in women treated for breast cancer, Additionally, exercises are an effective intervention to improve quality of life, cardiorespiratory fitness, physical functioning and fatigue in breast cancer patients. However, in the postoperative period consideration should be given to the early implementation of exercises because of the potential for seroma and increases in wound drainage volume and duration.
There is limited evidence on the influence of postoperative physiotherapy intervention, and instruction program on upper limb range of motion and return to physical activity divided by the type of surgery and regarding complications.
研究概览
详细说明
Aim The aim of this study is to evaluate the influence of early postoperative physical therapy program on upper-limb function and returning to physical activity in the first 6 months following surgery.
Hypotheses
- Early physical activity performed post-operative will improve ROM and therefore, will help women after breast surgeries to return faster to their routine physical activity and by that promote physical health.
- Early postoperative physical therapy is safe when the program for is tailored to the type of surgery.
Methods
Study design Parallel group prospective randomized controlled clinical trial. Two surgical department's including general surgery department and genecology department in Assuta hospital, Tel Aviv, Israel
Sample All women undergoing breast cancer surgeries in Assuta hospital between 02.01.2018 and till 07.01.2019 will be randomized into two groups: Group A (intervention group) will be instructed first day post-operative to exercise program; Group B (control group) without intervention.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Tel Aviv、以色列、69710
- Assuta Medican Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women
- Age 18-65.
- Diagnosed with breast cancer, undergoing breast surgery,
- Functional independence prior to the operation.
- Ability to communicate in Hebrew.
Exclusion Criteria:
- Cognitive disorders, patients unable to sign the consent form.
- Back and spinal morbidity.
- Fibromyalgia or chronic pain disorders.
- Neurological disorders.
- Renal failure with the need for dialysis.
- Lymphedema prior to surgery.
- History of breast surgery.
- Shoulder surgery or shoulder injuries with limited ROM.
- Ischemic heart disease, heart failure and radical heart insufficiency.
- Radical mastectomy, LD and DEIP reconstruction, exchange breast prosthesis.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Breast surgery and exercise
Patient that underwent breast surgery only without other intervention with exercise of the upper limb and instruction to continue after discharge.
|
EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
|
|
有源比较器:Breast surgery and no exercise
Patient after breast surgery alone are discharged without exercise and instructions.
|
EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
|
|
有源比较器:Breast, axilar surgery with exercise
Patients that underwent surgery of the breast and axilar lymph node surgery with exercise of the upper limb and instruction to continue after discharge.
|
EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
|
|
有源比较器:Breast, axillar surgery without exercise
The patients that underwent surgery of the breast and axilar nodes samples or dissection are discharged without exercise and instructions.
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EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
|
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 |
|---|---|---|
|
Shoulder pain
大体时间:6 mnth
|
The intensity of pain and chronological modification will be monitored
|
6 mnth
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Function of upper limb
大体时间:six month
|
The mobility of the shoulder will be evaluates in all movements
|
six month
|
|
Complications
大体时间:six month
|
Possible complications after surgery will be recorded
|
six month
|
|
Lymph edema
大体时间:6 mnth
|
Radius of upper limb will be measured
|
6 mnth
|
|
physical activities influence in recovery after breast cancer surgery
大体时间:6 mnth
|
patient will be agruped by intensity and frequency of PA
|
6 mnth
|
合作者和调查者
调查人员
- 研究主任:Sergio G Susmallian, MD、Assuta Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究协议
- 知情同意书 (ICF)
- 临床研究报告(CSR)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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