Physical Activity and Lymphedema Project (PAL Trial)

在乳腺癌（BrCa）治疗导致的发病率中，水肿是最令人恐惧和最普遍的疾病之一，在美国估计有2- 400，000例确诊病例。水肿导致的手臂尺寸增加可能导致运动和功能范围减少，肌肉力量下降，并改变日常生活活动。幸存者可能会发现水肿比乳房切除术更痛苦，因为它不太可能隐藏身体表现和手臂功能丧失。力量训练是BrCa幸存者的一种有趣的干预措施，因为有证据表明运动可以改善健康参数，生活质量和手臂发病症状。然而，尽管缺乏前瞻性的科学研究表明这种运动会使BrCa幸存者面临水肿的风险，但目前的临床指南建议不要参加剧烈的上身运动，特别是举起重量超过5至15磅的物体。这些限制极大地限制了幸存者可能参加的活动，从而对健康、功能和生活质量产生了不利影响。力量训练可以让女性在一个可控的环境中逐渐增加力量，这样就不太可能在日常生活中偶尔进行需要费力的上身工作（铲雪，抱孩子）的活动，而会使淋巴系统过度紧张。这项建议源于一项为期6个月的随机对照试验的令人信服的初步数据，该试验对81名最近的BrCa幸存者进行每周两次的渐进式力量训练;在治疗组中，先前诊断为水肿的女性没有发生水肿或症状恶化。这些数据，结合文献中的其他报告，支持这一随机对照试验的建议，以评估每周两次渐进式力量训练对水肿症状和淋巴系统生理学的影响，以及生活质量参数，与非运动对照组相比。我们将招募288名幸存者（144名患有水肿。144例无水肿），在BrCa诊断后5-15年参与该随机对照运动干预，包括2组（每组n= 144）。随机化将在水肿状态下进行。从这项研究中获得的知识可能会影响治疗方案的建议，参与日常生活活动，并建议运动促进BrCa幸存者的健康。

Of the morbidities resultant to breast cancer (BrCa) treatment, lymphedema is one of the most feared and prevalent with an estimated 2-400,000 diagnosed cases in the U.S. Increased ann size resultant to lymphedema may cause decreased range of motion and function, decreased muscle strength, and alters activities of daily living. Survivors may find lymphedema more distressing than mastectomy as it is less possible hide the physical manifestation and loss of arm function. Strength training is an intriguing intervention for BrCa survivors, as there is evidence exercise improves health parameters, quality of life and symptoms of arm morbidity. However, despite a lack of prospective scientific research to indicate such exercise puts BrCa survivors at risk for lymphedema, current clinical guidelines advise against participating in vigorous upper body exercise, and in particular, lifting objects that weigh more than 5 to 15 pounds. These restrictions greatly limit activities in which survivors may participate, which then negatively impacts health, function and quality of life. Strength training allows women to gradually increase strength in a controlled setting, making it less likely that the occasional activities of daily living that require strenuous upper body work (shoveling snow, carrying children) would over-stress the lymphatic system. This proposal stems from compelling preliminary data from a 6 month randomized controlled trial of progressive twice-weekly strength training in 81 recent BrCa survivors; in the treatment group, there was no onset of lymphedema or worsening of symptoms in women who had been previously diagnosed with lymphedema.. These data, combined with other reports in the literature, support this proposal of a randomized controlled trial to evaluate the effects of twice-weekly progressive strength training on lymphedema symptoms and physiology of the lymphatic system, as well as quality of life parameters, compared to a non-exercising control goup. We will recruit 288 survivors (144 with lymphedema. 144 without lymphedema) 5-15 years post-BrCa diagnosis to participate in this randomized controlled exercise intervention consisting of 2 groups (n= 144 per group). Randomization will occur within lymphedema status. The knowledge gained from this study may impact recommendations for therapeutic regimens, participation in activities of daily living, and recommendations for exercise for health promotion in BrCa survivors.