Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema: A Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Change from Baseline in Affected Upper Extremity Volume
研究概览
简要总结
A total of 64 women, aged between 20 and 65 years, diagnosed with stage I or II breast cancer-related lymphedema and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Medical Faculty, will be included in our thesis study, which is planned to be prospective, randomized, and single-blind. Participants will be informed verbally and in writing about the study's purpose, duration, and method of implementation, and written informed consent will be obtained. They will be asked to sign an "Informed Consent Form." Participant assessment and follow-up forms will be completed before and after treatment. Participants who meet the inclusion criteria will be numbered according to their order of admission and then randomly assigned to either the intervention group or the control group by a computer program.
All participants will receive a face-to-face education session about breast cancer-related lymphedema, including exercise, self-lymphatic drainage, skin care, compression garment use, and self-management, together with an educational brochure. Participants in both groups will be asked to continue wearing their prescribed compression garments throughout the study. In addition to this education, the intervention group (G1) will join live Zoom sessions with the study physician three times a week for 8 weeks to perform the exercise and self-lymphatic drainage program under real-time supervision. Each session will include approximately 30 minutes of therapeutic exercises followed by 15 minutes of self-lymphatic drainage.
The control group (G2) will receive the same exercise and self-lymphatic drainage program in brochure format, including written instructions and illustrations. Participants will be asked to perform the exercise and self-lymphatic drainage program at home three times a week for 8 weeks without live online supervision.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants between 20 and 65 years of age
- •History of unilateral breast cancer surgery including axillary lymph node dissection
- •Completion of breast cancer treatments, including surgery, radiotherapy, and chemotherapy, with at least 3 months elapsed since treatment completion
- •Diagnosis of stage I or stage II upper extremity lymphedema according to the International Society of Lymphology (ISL) classification
- •Presence of at least 5% volume difference between the affected and unaffected upper extremities
- •No history of manual lymphatic drainage, compression bandaging treatment, or structured resistance exercise program within the previous 3 months
- •Ability to use a smartphone or tablet and sufficient cognitive and motor ability to participate in digital sessions
- •Prescription of an appropriate compression garment for the affected extremity and regular use of the garment as recommended
排除标准
- •Presence of uncontrolled hypertension, pulmonary edema, or severe cardiovascular disease
- •Presence of psychiatric or cognitive impairment that may interfere with study participation or adherence
- •Presence of stage III lymphedema according to the ISL classification
- •Presence of skin lesions such as papilloma or hyperkeratosis in the lymphedematous area
- •History of bilateral breast cancer
- •Presence of active cancer or clinical/radiological evidence of metastasis
- •Presence of active infection in the affected extremity
研究组 & 干预措施
Intervention Group
In addition to a face-to-face education session and educational brochure, participants will receive the exercise and self-lymphatic drainage program through live Zoom sessions with the study physician three times a week for 8 weeks.
干预措施: Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program (Other)
Control Group
Face-to-face education session and educational brochure with the same exercise and self-lymphatic drainage program performed as a home-based program three times a week for 8 weeks.
干预措施: Home-Based Exercise and Self-Lymphatic Drainage Program (Other)
结局指标
主要结局
Change from Baseline in Affected Upper Extremity Volume
时间窗: Baseline (before starting treatment), Week 8 (end of intervention), Week 12 (one month after the end of intervention)
Limb volume is an objective measure used to evaluate swelling associated with upper extremity lymphedema. Bilateral arm circumference measurements will be obtained using a low-stretch measuring tape at six reference points: the metacarpophalangeal joint, wrist joint, 10 and 15 cm distal to the lateral epicondyle, and 10 and 15 cm proximal to the lateral epicondyle. Bilateral upper limb volume will be calculated indirectly using the truncated cone formula. The change from baseline in affected upper extremity volume will be evaluated as the primary outcome. Treatment response will additionally be assessed using the excess volume difference between the affected and unaffected limbs and the percentage change in excess volume (PCEV). Lymphedema severity will also be classified according to the excess limb volume difference as minimal (5-\<20% increase), moderate (20-40% increase), and severe (\>40% increase).
次要结局
- Lymphedema Stage(Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention))
- Visual Analog Scale (VAS) for Lymphedema Symptom Severity(Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
- Hand Grip Strength(Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention))
- Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)(Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention))
- Lymphedema Quality of Life Questionnaire - Arm (LYMQOL-Arm)(Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention))
- Breast Cancer-Related Lymphedema Self-Care Scale(Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention))
- Lymphedema Self-Management Adherence Monitoring Form(From baseline to Week 12 (during the 8-week intervention period and 4-week follow-up period))
- Patient Satisfaction with Tele-rehabilitation Program(Week 8 (end of intervention))
研究者
İlayda Gürsoy
medical doctor
Istanbul University