Assessing gait, balance, and muscle strength among breast cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN): study protocol for a randomized controlled clinical trial.
Assessing gait, balance, and muscle strength among breast cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN): study protocol for a randomized controlled clinical trial.
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化疗诱导的周围神经病变（CIPN）是紫杉烷化疗治疗乳腺癌的常见和研究不足的后果。CIPN症状包括麻木伴麻刺感、持续的刺痛、刺伤或烧灼痛（即使没有疼痛刺激）、下肢肌无力和平衡受损。CIPN症状通常在化疗完成后持续很长一段时间，导致功能能力的显著丧失和福尔斯风险增加。由于治疗选择有限，紫杉烷类引起的持续性CIPN代表了治疗挑战。抗阻运动已经显示出有希望的结果，然而，运动对CIPN的影响仍然研究不足。本研究旨在评估16周的家庭锻炼计划与教育注意力控制条件相比，锻炼对步态，平衡和下肢肌肉力量的影响。从社区居住样本中招募了312名完成紫杉烷为基础的乳腺癌化疗并有症状性神经病变的妇女。参与者被随机分配到为期16周的家庭体育活动干预组或教育注意力对照组。基于家庭的干预方案包括有针对性的下肢伸展，然后是10分钟的步态/平衡和10分钟的阻力训练，通过超链接或DVD访问。运动日记记录定量运动数据。步态评估包括时空参数和下肢关节角度使用APDM运动传感器。使用NeuroCom平衡大师进行的感觉组织测试（SOT）评估参与者的平衡。使用等速测力计Biodex BX Advantage评估髋关节、膝关节和踝关节屈肌和伸肌的等长力量。此外，我们使用FACT-Taxane其他关注子量表和腓肠神经和腓神经动作电位的神经传导速度评估神经病变症状。在基线（随机分组前）和16周时评估结局。目前还没有循证干预措施来解决与CIPN相关的功能下降。如果成功的话，这个计划是简单的，易于实施的护理标准与CIPN个人。步态和平衡训练有可能减少与CIPN相关的身体功能障碍，并减轻癌症幸存者的疾病负担。ClinicalTrials.gov NCT 04621721。于2020年8月3日注册。ClincialTrials.gov是世界卫生组织国际临床试验注册平台（WHO ICTEP）网络的主要注册中心，包括试验注册中WHO试验注册数据集的所有项目。在线版本包含补充材料，可通过10.1186/s13063-022-06294-w获取。
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and understudied consequence of taxane chemotherapy for breast cancer treatment. CIPN symptoms include numbness combined with tingling sensations, persistent shooting, stabbing, or burning pain even in the absence of painful stimuli, lower extremity muscle weakness, and impaired balance. CIPN symptoms often persist for a long time after completion of chemotherapy, causing significant loss of functional abilities and increased risk of falls. Persistent CIPN caused by taxanes represents a therapeutic challenge due to the limited treatment options. Resistance exercise has shown promising results; however, the effect of exercise on CIPN remains understudied. This study aims to assess the effects of exercise on gait, balance, and lower extremity muscle strength after a 16-week home-based exercise program compared to an educational attention control condition. A sample of 312 women who completed taxane-based chemotherapy for breast cancer and have symptomatic neuropathy is recruited from a community-dwelling sample. Participants are randomized to either a 16-week Home-Based Physical Activity Intervention or an Educational Attention control group. The home-based intervention protocol consists of targeted lower extremity stretches, followed by 10 min each of gait/balance and 10 min of resistive training accessed by hyperlink or DVD. An Exercise Diary records quantitative exercise data. The gait assessment includes temporospatial parameters and lower extremity joint angles using APDM motion sensors. Participants’ balance is assessed using the Sensory Organization Test (SOT) performed using a NeuroCom Balance Master. Isometric strength of hip, knee, and ankle flexor and extensor muscles is assessed using an isokinetic dynamometer, Biodex BX Advantage. In addition, we assess neuropathy symptoms using the FACT-Taxane Additional Concerns Subscale and nerve conduction velocity of the sural and peroneal nerve action potentials. Outcomes are assessed at baseline (prior to randomization) and 16 weeks. There are currently no evidence-based interventions that address the functional declines associated with CIPN. If successful, this program is simple and easy to implement in the standard of care for individuals with CIPN. Gait and balance training have the potential to reduce physical dysfunction associated with CIPN and reduce the burden of disease in cancer survivors. ClinicalTrials.gov NCT04621721. Registered on August 3, 2020. ClincialTrials.gov is a primary registry of the World Health Organization International Clinical Trials Registry Platform (WHO ICTEP) network and includes all items from the WHO Trial Registration data set in Trial registration. The online version contains supplementary material available at 10.1186/s13063-022-06294-w.
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DOI：
10.1038/nrneurol.2014.77
发表时间：
2014-06
期刊：
Nature reviews. Neurology
影响因子：
--
作者：
Bennett GJ;Doyle T;Salvemini D
通讯作者：
Salvemini D
影响因子：
0.5
作者：
Sohn EH;Lee JS;Jung MS;Kim JR
通讯作者：
Kim JR
影响因子：
3.1
作者：
Mancini M;Horak FB
通讯作者：
Horak FB
影响因子：
4.2
作者：
Maffiuletti, Nicola A.;Bizzini, Mario;Munzinger, Urs
通讯作者：
Munzinger, Urs
DOI：
10.1007/s00520-017-4013-0
发表时间：
2018-04
期刊：
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
影响因子：
--
作者：
Kleckner IR;Kamen C;Gewandter JS;Mohile NA;Heckler CE;Culakova E;Fung C;Janelsins MC;Asare M;Lin PJ;Reddy PS;Giguere J;Berenberg J;Kesler SR;Mustian KM
通讯作者：
Mustian KM