Timing of Specific Exercise Therapy After Breast Cancer Surgery: A Single-Center, Parallel-Group Randomized Controlled Trial Comparing Early (<1 Week Postoperative) Versus Delayed (3 Weeks Postoperative) Initiation for Optimized Upper Limb Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Upper Limb Function (DASH Questionnaire)
研究概览
简要总结
This single-center, parallel-group randomized controlled trial (RCT) will compare two timings for initiating specific exercise therapy after breast cancer surgery. The study tests whether early initiation (within the first postoperative week) versus delayed initiation (at 3 weeks postoperative) results in superior upper limb function at 6 months as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Secondary outcomes include pain intensity (Visual Analog Scale, VAS) and wound-related complications such as drainage time and hematoma incidence.
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)
盲法说明
Given the nature of the intervention timing, participants, care providers, and investigators are unblinded; however, those assessing the primary and secondary outcomes will be blinded to treatment group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-65 years.
- •Scheduled to undergo breast cancer surgery with axillary node dissection.
- •At risk for upper limb morbidity based on preoperative assessment.
- •Able to provide informed consent and complete study questionnaires.
- •Willing and able to attend scheduled physiotherapy sessions and follow-up evaluations.
排除标准
- •Diagnosis of recurrent or metastatic breast cancer.
- •Concurrent participation in another rehabilitation intervention or clinical trial.
- •Severe comorbidities (e.g., uncontrolled cardiovascular disease, severe orthopedic conditions) that preclude safe participation.
- •History of previous shoulder surgery or chronic upper extremity musculoskeletal disorders unrelated to breast cancer treatment.
- •Inability to understand or complete study materials in English.
- •Pregnancy or lactation.
研究组 & 干预措施
Early Initiation of Specific Exercise Therapy
In this group, participants will initiate specific exercise therapy within the first postoperative week. They will receive 40-minute supervised sessions twice weekly for 8 weeks, with a transition to a prescribed home-based maintenance program for an additional 4 months.
干预措施: Specific Exercise Therapy (Behavioral)
Delayed Initiation of Specific Exercise Therapy
Participants in this group will begin the same specific exercise therapy protocol at 3 weeks postoperative. Otherwise, the intervention is identical to that provided to the Early Therapy group.
干预措施: Specific Exercise Therapy (Behavioral)
结局指标
主要结局
Upper Limb Function (DASH Questionnaire)
时间窗: Assessed preoperatively (baseline) and at 6 months postoperative.
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire is a validated measure of upper limb function. The questionnaire is scored on a continuous scale ranging from 0 to 100, where 0 indicates no disability and 100 represents the most severe disability. Lower scores indicate better upper limb function.
次要结局
- Wound-Related Complications - Drainage Time (Days)(Monitored during the immediate postoperative period up to 3 months.)
- Pain Intensity (Visual Analog Scale - VAS)(Assessed at baseline and at 1, 3, and 6 months postoperative.)
- Wound-Related Complications - Incidence of Hematoma(Monitored during the immediate postoperative period up to 3 months.)