Effect of Exercise Training at Different Timeline on Shoulder Dysfunction in Patients After Breast Cancer Modified Radical Mastectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Constant-Murley Shoulder Score
研究概览
简要总结
Patients who underwent modified radical mastectomy were enrolled in the study. 200 subjects were randomly divided into 4 groups: 7 days postoperative shoulder isotonic training + 4 weeks postoperative progressive resistance training group, postoperative 7 Isometric training for the shoulder joint + progressive resistance training for 3 weeks after surgery group, 3 days postoperative isotope training + 4 weeks postoperative progressive resistance training group, 3 days postoperative shoulder isotonic training + postoperative 3 Weekly progressive resistance training group. The effects of interventional rehabilitation at different time points on the recovery of shoulder function after breast cancer operation were observed. The results of the study will provide evidence-based evidence for the time point of intervention in early functional exercise after modified radical mastectomy for breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 25 and 75 years;
- •Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks;
- •Patients undergoing modified radical mastectomy: mastectomy includes unilateral total breast or breast-conserving surgery, as well as dissection of the affected axillary lymph nodes, but does not include sentinel lymph node biopsy;
- •Postoperative chemotherapy or radiation therapy according to the condition;
- •No other malignant tumors within 5 years;
- •No physical therapy related contraindications;
- •Signing informed consent.
排除标准
- •The result of SLNB is negative who did not receive ALND;
- •Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.);
- •Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.);
- •Combined severe heart disease, cerebrovascular disease, and mental illness;
- •Patients with shoulder joint dysfunction before surgery;
- •Unable to understand the rehabilitation training program provided by doctors or physiotherapists.
结局指标
主要结局
Constant-Murley Shoulder Score
时间窗: 18 weeks after surgery
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.
次要结局
- The power of gripping(1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery)
- Shoulder joint muscle strength(3 days, 3, 6, 9 weeks after surgery)
- EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire(1, 3, 9, 12, 18 weeks after surgery)
- SF-36 Health status questionnaire(1, 3, 9, 12, 18 weeks after surgery)
- Active and passive range of motion(3 days，1, 2, 3, 6, and 9 weeks after surgery)
研究者
Qing Shu
Principal Investigator
Wuhan University