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.
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.
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乳腺癌（BC）是女性经历的最常见的癌症形式之一。高达80%的接受化疗的BC幸存者经历化疗诱导的神经病变（CIN），其降低运动控制、感觉功能和生活质量。CIN症状包括四肢麻木、刺痛和/或烧灼感;神经运动控制缺陷;跌倒风险增加。身体活动（PA）和音乐医学（MBM）是解决感觉运动症状的有希望的途径。因此，我们建议，我们可以联合收割机的音乐和PA为基础的医学效果，通过神经舞蹈训练（NDT）通过合作适应探戈（NDT-Tango）。我们将评估NDT-Tango与家庭锻炼（HEX）干预对生物力学测量变量的干预效果。我们假设，8周的NDT探戈练习将改善姿势和步态的动力学超过8周的HEX。在一项单中心、前瞻性、双臂随机对照临床试验中，受试者被随机分配（1：1比例）至NDT-Tango实验组或HEX活性对照干预组。主要终点是姿势和步态从基线到干预后的变化。在基线、中点、治疗后、1个月随访和6个月随访时收集结局。第二和第三结局包括功能的临床和生物力学测试以及用于补充主要结局指标的问卷调查。将使用线性混合模型对姿势、生物力学和PRO的变化进行建模。主要被估量将是代表治疗组之间结局指标从基线至第8周的平均变化差异的对比度。本研究的科学前提是，NDT探戈站在实现更多的收益比PA实践单独通过PA与MBM和社会参与相结合。我们的研究结果可能会导致一个安全的非药物干预，改善CIN相关的缺陷。本试验于2021年9月11日首次发布于ClinicalTrials.gov，标识符为NCT 05114005。
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.
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影响因子：
28.4
作者：
Dueck AC;Mendoza TR;Mitchell SA;Reeve BB;Castro KM;Rogak LJ;Atkinson TM;Bennett AV;Denicoff AM;O'Mara AM;Li Y;Clauser SB;Bryant DM;Bearden JD 3rd;Gillis TA;Harness JK;Siegel RD;Paul DB;Cleeland CS;Schrag D;Sloan JA;Abernethy AP;Bruner DW;Minasian LM;Basch E;National Cancer Institute PRO-CTCAE Study Group
通讯作者：
National Cancer Institute PRO-CTCAE Study Group
影响因子：
2
作者：
Evans, Elizabeth S.;Ketcham, Caroline J.;Murphy, Dorriea L.
通讯作者：
Murphy, Dorriea L.
影响因子：
2.4
作者：
Dingwell, Jonathan B.;Kang Hyun Gu;Marin, Laura C.
通讯作者：
Marin, Laura C.
影响因子：
1.9
作者：
Worthen-Chaudhari L;McGonigal J;Logan K;Bockbrader MA;Yeates KO;Mysiw WJ
通讯作者：
Mysiw WJ
影响因子：
0.8
作者：
Hackney, Madeleine E.;Earhart, Gammon M.
通讯作者：
Earhart, Gammon M.