Effectiveness of a Therapeutic Exercise Program With Specific Upper Limb Exercises to Reduce Lymphedema and Neuropathy in Breast Cancer Patients: A Pre-post Study (LYNMA)

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Therapeutic exercise
  Participants will follow a 3-month therapeutic exercise program combining general exercises with specific upper limb exercises, including hand proprioception and neurodynamic techniques. Two group sessions per week (1 to 1.15 hours each) will be conducted, with at least 24 hours between sessions. Each session includes warm-up, three progressive work blocks with strength, mobility, and balance exercises, and a cool-down. Strength training uses body weight and equipment, with intensity guided by t

Первичные конечные точки

• Excess limb volume (%) compared to the unaffected limb [Срок оценки: Baseline (before intervention), Immediately post-program (Day 0 after completion)]

Вторичные конечные точки (6)

• Change in neuropathic pain intensity measured with DN4 questionnaire [Срок оценки: Baseline (before intervention), Immediately post-program (Day 0 after completion)]
• Change in hand grip strength from baseline measured with handheld dynamometer (kg) [Срок оценки: Baseline (before intervention), Immediately post-program (Day 0 after completion)]
• Change in nerve cross-sectional area measured with high-resolution ultrasound (mm²) [Срок оценки: Baseline (before intervention), Immediately post-program (Day 0 after completion)]
• Change in upper limb function measured with QuickDASH questionnaire (score 0-100) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (before intervention), Immediately post-program (Day 0 after completion)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07170631 · FIS-2025-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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