Prehabilitation in Breast Cancer Surgery: A Prospective Randomized Controlled Trial Evaluating Shoulder Function, Pain, Quality of Life and Lymphedema Development
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Shoulder Range of Motion (degrees)
研究概览
简要总结
This prospective, randomized, assessor-blinded, parallel-group clinical trial evaluates the effectiveness of a home-based upper extremity-focused prehabilitation program in women undergoing breast cancer surgery. Participants will be randomized 1:1 to either prehabilitation or usual care. Primary outcomes include shoulder range of motion and upper extremity function (DASH score). Secondary outcomes include grip strength, pain, fatigue, disability, anxiety/depression, and lymphedema incidence up to 2 years postoperatively.
详细描述
Breast cancer surgery is associated with postoperative morbidity including shoulder dysfunction, pain, fatigue, and lymphedema. Prehabilitation aims to optimize functional capacity before surgery and may reduce postoperative complications.
This single-center randomized controlled trial will enroll 54 women with stage I-III invasive breast cancer scheduled for mastectomy or breast-conserving surgery. Participants will be randomized to:
- Home-based structured prehabilitation program
- Usual preoperative care
Primary endpoints are shoulder range of motion (goniometric measurement) and DASH score changes across multiple time points. Participants will be followed for up to 24 months for lymphedema development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-80
- •Stage I-III invasive breast cancer
- •Scheduled for surgery
- •≥3 weeks before surgery
- •No neoadjuvant therapy
排除标准
- •Exercise contraindication
- •Active shoulder pathology
- •Severe cardiopulmonary disease
- •Planned neoadjuvant therapy
研究组 & 干预措施
Prehabilitation Group
Participants will receive a structured home-based prehabilitation program delivered through written materials and instructional exercise videos (QR code access). The program includes:
Aerobic training (3/week, 30-40 minutes, RPE 4-6) Upper extremity resistance exercises (3 days/week, 3 sets of 10 repetitions) Mobility and stretching exercises
Adherence will be monitored through weekly remote follow-up (telephone)
干预措施: Home-Based Prehabilitation Exercise Program (Other)
Usual Care
Standard preoperative counseling without structured exercise prescription.
干预措施: Usual Care (Other)
结局指标
主要结局
Change in Shoulder Range of Motion (degrees)
时间窗: Baseline to 12 weeks post-op
Measured by goniometer
DASH Score
时间窗: Baseline to 12 weeks post-op
Change in DASH Score The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item patient-reported outcome measure assessing upper extremity disability and symptoms. Scores range from 0 to 100, with higher scores indicating greater disability and worse functional status.
次要结局
- Grip Strength(Baseline to 12 weeks post-op)
- Pain (Brief Pain Inventory - BPI)(baseline to 12 weeks)
- Fatigue (Functional Assessment of Cancer Therapy - Fatigue; FACT-F)(0-12 months)
- Disability (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)(baseline to 12 weeks)
- Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)(baseline to 12 weeks)
- Lymphedema Incidence(baseline to 2 years postop)
研究者
Demet Ferahman
M.D.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital