乳腺癌幸存者由化疗引起的神经病理的神经舞蹈训练(NDT)的生物力学效应:一项随机对照试验和初步基线数据的研究方案。
Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trial and preliminary baseline data.
发表日期:2023 Sep 01
作者:
Kristen Lantis, Patrick Schnell, Courtney R Bland, Jacqueline Wilder, Karen Hock, Craig Vargo, Nelson A Glover, Madeleine E Hackney, Maryam B Lustberg, Lise Worthen-Chaudhari
来源:
MEDICINE & SCIENCE IN SPORTS & EXERCISE
摘要:
乳腺癌(BC)是女性最常见的癌症之一。高达80%的接受化疗的BC幸存者会出现化疗引起的神经病变(CIN),这会降低运动控制、感觉功能和生活质量。CIN症状包括四肢麻木、刺痛和/或灼热感、神经运动控制缺陷以及增加摔倒风险。体力活动(PA)和基于音乐的医学(MBM)是解决感觉运动症状的有前途的途径。因此,我们提出可以通过神经舞蹈训练(NDT)中结合音乐和PA的医学效应,通过合作改编探戈(NDT-Tango)来实现。我们将评估NDT-Tango与家庭运动(HEX)干预的干预效果对生物力学测量变量的影响。我们假设进行8周的NDT-Tango练习与8周的HEX相比,可以更改姿势和步态的动力学。在一项单中心、前瞻性、两臂随机对照临床试验中,参与者被随机分配(1:1比例)到NDT-Tango实验组或HEX活跃对照干预组。主要终点是姿势和步态从基线到干预后的变化。结果将在基线、中点、干预后、1个月随访和6个月随访时收集。次要和三级终点包括功能性临床和生物力学测试以及用于补充主要终点测量的问卷。线性混合模型将用于模拟姿势、生物力学和PROs的变化。主要估计将是代表两个治疗组在基线到第8周的平均变化差异的对比。本研究的科学前提是,通过结合PA与MBM和社交参与,NDT-Tango有望实现更多收益。我们的发现可能会导致改善CIN相关缺陷的安全的非药物干预措施。该试验于11/09/21首次在ClinicalTrials.gov上发布,编号为NCT05114005。© 2023. BioMed Central Ltd.,Springer Nature的一部分。
Breast cancer (BC) is among the most common forms of cancer experienced by women. Up to 80% of BC survivors treated with chemotherapy experience chemotherapy-induced neuropathy (CIN), which degrades motor control, sensory function, and quality of life. CIN symptoms include numbness, tingling, and/or burning sensations in the extremities; deficits in neuromotor control; and increased fall risk. Physical activity (PA) and music-based medicine (MBM) are promising avenues to address sensorimotor symptoms. Therefore, we propose that we can combine the effects of music- and PA-based medicine through neurologic dance training (NDT) through partnered Adapted Tango (NDT-Tango). We will assess the intervention effect of NDT-Tango v. home exercise (HEX) intervention on biomechanically-measured variables. We hypothesize that 8 weeks of NDT-Tango practice will improve the dynamics of posture and gait more than 8 weeks of HEX.In a single-center, prospective, two-arm randomized controlled clinical trial, participants are randomly assigned (1:1 ratio) to the NDT-Tango experimental or the HEX active control intervention group. Primary endpoints are change from baseline to after intervention in posture and gait. Outcomes are collected at baseline, midpoint, post, 1-month follow-up, and 6-month follow-up. Secondary and tertiary outcomes include clinical and biomechanical tests of function and questionnaires used to compliment primary outcome measures. Linear mixed models will be used to model changes in postural, biomechanical, and PROs. The primary estimand will be the contrast representing the difference in mean change in outcome measure from baseline to week 8 between treatment groups.The scientific premise of this study is that NDT-Tango stands to achieve more gains than PA practice alone through combining PA with MBM and social engagement. Our findings may lead to a safe non-pharmacologic intervention that improves CIN-related deficits.This trial was first posted on 11/09/21 at ClinicalTrials.gov under the identifier NCT05114005.© 2023. BioMed Central Ltd., part of Springer Nature.