Effectiveness of a General Therapeutic Exercise Program Including Specific Upper Limb Exercises to Reduce Lymphedema and Peripheral Neuropathy Secondary to Oncological Treatment in Patients With Breast Cancer: A Pre-post Intervention Study (LYNMA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Excess limb volume (%) compared to the unaffected limb
研究概览
简要总结
This study aims to evaluate the effectiveness of a therapeutic exercise program designed specifically for women with breast cancer. The program includes general exercises along with specific movements for the upper limb to help reduce common side effects of cancer treatment such as lymphedema (swelling of the arm) and neuropathy (nerve pain or numbness). Participants will undergo the exercise program and be assessed before and after to determine improvements in their symptoms and overall quality of life. The goal is to provide evidence that targeted physical therapy can improve recovery and well-being in breast cancer survivors.
详细描述
This pre-post intervention study aims to assess the effectiveness of a comprehensive therapeutic exercise program tailored for breast cancer patients experiencing lymphedema and neuropathy secondary to cancer treatment. The program combines general physical exercises with specific upper limb movements targeting symptom reduction and functional improvement. Participants will be evaluated before and after the intervention to measure changes in arm swelling, nerve symptoms, physical function, and quality of life. The study will contribute valuable data on non-pharmacological rehabilitation strategies that could enhance recovery and reduce long-term complications in breast cancer survivors.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients receiving treatment for breast carcinoma.reatments include surgical procedures (breast-conserving surgery or mastectomy), axillary lymph node dissection, sentinel lymph node biopsy, radiotherapy, chemotherapy, and hormone therapy.
- •Participants must provide authorization from their primary care physician and/or oncologist to perform therapeutic exercise.
- •Diagnosis of lymphedema associated with stage I or II breast cancer (Stage 1 or mild: circumference difference less than 4 cm [volume difference 10-25%] compared to the healthy arm; Stage 2 or moderate: circumference difference between 4 and 6 cm [volume difference 25-50%] compared to the healthy arm).
- •A score of 4 or higher on the DN4 questionnaire (neuropathic pain)
排除标准
- •Lack of medical authorization.
- •Pre-existing cardiac pathology prior to cancer diagnosis.
- •Exacerbation of comorbidities.
- •Travel time exceeding 45 minutes to the location where the therapeutic exercise program is conducted.
研究组 & 干预措施
Therapeutic exercise
Participants will undergo a general therapeutic exercise program including specific upper limb exercises designed to reduce lymphedema and neuropathy secondary to cancer treatment. The program consists of supervised sessions two times per week over 12 weeks, led by a specialized physiotherapist. Exercises include mobility, strength, and neurodynamic techniques.
干预措施: Therapeutic exercise (Other)
结局指标
主要结局
Excess limb volume (%) compared to the unaffected limb
时间窗: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Excess volume of the affected limb (percentage compared to the unaffected limb). The volume of each limb will be measured manually using a measuring tape by taking circumferences every 4 centimeters from the wrist to the axilla. Limb volume will be calculated using the Kuhnke formula: Volume equals the sum of the squares of the circumferences (C1 squared plus C2 squared plus ... plus Cn squared) divided by pi, where C1, C2, … Cn are the circumferences measured at different points along the limb.
次要结局
- Change in neuropathic pain intensity measured with DN4 questionnaire(Baseline (before intervention), Immediately post-program (Day 0 after completion))
- Change in hand grip strength from baseline measured with handheld dynamometer (kg)(Baseline (before intervention), Immediately post-program (Day 0 after completion))
- Change in nerve cross-sectional area measured with high-resolution ultrasound (mm²)(Baseline (before intervention), Immediately post-program (Day 0 after completion))
- Change in upper limb function measured with QuickDASH questionnaire (score 0-100)(Baseline (before intervention), Immediately post-program (Day 0 after completion))
- Change in range of motion of shoulder rotations, elbow and wrist flexion-extension measured with goniometer (degrees)(Baseline (before intervention), Immediately post-program (Day 0 after completion))
- Change in quality of life from baseline measured with EORTC QLQ-C30 questionnaire (score 0-100)(Baseline (before intervention), Immediately post-program (Day 0 after completion))
研究者
Aïda Cadellans-Arróniz
PhD, Associate Professor
Universitat Internacional de Catalunya