Effects of Combined Upper Extremity Exercise and Pneumatic Compression Therapy on Breast Cancer-Related Lymphedema: A Prospective Single-Group Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Upper limb circumference point-by-point
研究概览
简要总结
Breast cancer is one of the most common cancers among women worldwide. With advances in treatment, survival rates have steadily increased; however, postoperative complications continue to affect patients' quality of life, with upper extremity lymphedema being among the most prevalent. Breast cancer related lymphedema (BCRL) can result in arm swelling, pain, restricted mobility, and psychological distress, all of which negatively impact daily functioning and social partici pation .
Previous studies have demonstrated that regular and moderate upper extremity exercise does not exacerbate lymphedema; instead, it may improve shoulder mobility, muscular strength, and contribute to edema control. In addition, therapeutic modalities such as pneumatic compression pumps and manual lymphatic drainage have been proven effective in reducing swelling and enhancing patient comfort . Recent systema tic reviews further support the beneficial effects of exercise interventions on upper limb function and quality of life in breast cancer survivors.
Therefore, combining upper extremity exercise with pneumatic compression therapy may re present a promising integrative intervention to improve lymphedema and related functional limitations. This study aims to investigate the effects of such a combined approach on breast cancer patients with lymphedema by comparing outcomes across multiple ti me points, including arm circumference measurements, shoulder range of motion, upper extremity function (DASH), and quality of life (FACT B), with the goal of establishing a more comprehensive rehabilitation model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer patients aged 20-70 years
- •Postoperative unilateral breast cancer surgery with a clinical diagnosis of lymphedema (stage I or II breast cancer treatment, with unilateral lymphedema greater than 2 cm and less than 8 cm at least one measurement point)
- •Completion of subsequent chemotherapy/radiotherapy or other treatments at least 3 months postoperatively
- •Ability to cooperate with 12 treatments and all assessments and sign a consent form
排除标准
- •Breast cancer with a tendency for recurrence or metastasis
- •Severe infection of the upper limb (cellulitis)
- •Uncontrolled heart failure, deep vein thrombosis (DVT), severe peripheral vascular disease
- •Stage III lymphedema, bilateral lymphedema, or need to take medications that may affect sweat glands in the upper limbs
- •Other musculoskeletal disorders of the upper limbs, joint deformities, or a history of surgery
- •Pregnancy or other conditions unsuitable for participation
研究组 & 干预措施
Combined Upper Extremity Exercise and Pneumatic Compression Therapy
Participants will receive a 6-week intervention consisting of structured upper extremity exercise combined with pneumatic compression therapy. Outcomes will be measured at baseline, post-treatment, and one-week follow-up.
干预措施: Combined Upper Extremity Exercise (Other)
Combined Upper Extremity Exercise and Pneumatic Compression Therapy
Participants will receive a 6-week intervention consisting of structured upper extremity exercise combined with pneumatic compression therapy. Outcomes will be measured at baseline, post-treatment, and one-week follow-up.
干预措施: Pneumatic Compression Therapy (Other)
结局指标
主要结局
Upper limb circumference point-by-point
时间窗: 5 weeks
Upper Limb Circumference Measurement Upper limb circumference was measured using a non-elastic standard measuring tape at predefined anatomical landmarks to assess limb swelling. Measurement Sites: Elbow joint 5 cm, 10 cm, and 15 cm proximal to the elbow 5 cm, 10 cm, and 15 cm distal to the elbow Wrist joint Circumference was recorded in centimeters (cm) at each site. Greater circumference values indicate greater limb swelling, while lower values indicate reduction of lymphedema. Standardization Procedures: All measurements were performed by the same trained assessor. Measurements were conducted within the same time window (e.g., 9:00 AM-12:00 PM). Participants rested for 10 minutes prior to measurement. Measurements were obtained with the participant in the same standardized posture at each assessment time point.
shoulder range of motion
时间窗: 5 weeks
Shoulder Range of Motion (ROM) is measured using a standard goniometer to assess active shoulder movements, including flexion, extension, abduction, adduction, internal rotation, and external rotation. ROM is measured in degrees (°). Higher values indicate greater joint mobility and better functional movement. There is no fixed minimum or maximum score, as normal values vary by movement; however, greater degrees reflect better shoulder function.
Disabilities of the Arm, Shoulder and Hand questionnaire, DASH
时间窗: 5weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a self-reported measure of upper extremity function and symptoms. The DASH score ranges from 0 to 100. 0 indicates no disability (best function). 100 indicates most severe disability (worst function). Higher scores represent worse upper extremity function and greater disability.
Functional Assessment of Cancer Therapy-Breast Cancer
时间窗: 5 weeks
The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a validated self-reported questionnaire assessing quality of life in patients with breast cancer. It includes physical, social/family, emotional, functional well-being, and breast cancer-specific concerns. The total FACT-B score ranges from 0 to 148. Higher scores indicate better quality of life. Lower scores indicate poorer quality of life.
次要结局
未报告次要终点