Effects of electrical muscle stimulation in frail elderly patients during haemodialysis (DIAL): rationale and protocol for a crossover randomised controlled trial.
Effects of electrical muscle stimulation in frail elderly patients during haemodialysis (DIAL): rationale and protocol for a crossover randomised controlled trial.
复制标题
血液透析（DIAL）期间肌肉电刺激对虚弱老年患者的影响：交叉随机对照试验的基本原理和方案。
DOI：
10.1136/bmjopen-2018-025389
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发表时间：
2019
期刊：
影响因子：
2.9
通讯作者：
Suzuki Y,Kamiya K,Tanaka S,Hoshi K,Watanabe T,Harada M,Matsuzawa R,Shimoda T,Yamamoto S,Matsunaga Y,Yoneki K,Yoshida A,Matsunaga A
中科院分区：
文献类型：
--
作者：
Tsukamoto S;Mavrogenis AF;van Langevelde K;van Vucht N;Kido A;Errani C.;若野世奈，土田和可子，浅川真由，松尾真吾，鈴木重行，浅井友詞;Nemoto S,Kasahara Y,Izawa KP,Watanabe S,Yoshizawa K,Takeichi N,Kamiya K,Suzuki N,Omiya K,Matsunaga A,Akashi YJ;Suzuki Y,Kamiya K,Tanaka S,Hoshi K,Watanabe T,Harada M,Matsuzawa R,Shimoda T,Yamamoto S,Matsunaga Y,Yoneki K,Yoshida A,Matsunaga A
引言人口老龄化现象伴随着全球老年血液透析患者数量的增加。血液透析人群虚弱的发生率很高，并且与不良的临床结果相关。尽管已经开发出几种用于一般血液透析患者的干预措施，但此类康复计划对年老体弱的血液透析患者的疗效尚未阐明。在这里，我们检查了肌肉电刺激 (EMS) 是否会对进行血液透析的虚弱老年患者显示出有益的效果。方法和分析这是一项随机、两阶段、对照交叉试验，将招募 20 名患者。年龄 ≥ 65 岁并被定义为体弱的血液透析患者（即体能电池评分 4-9 分）将按 1:1 的比例随机分配到第 1 组（在治疗期 I 开始进行 EMS 干预，然后在 5 周的清除期后在治疗期 II 中重新分配为对照）或第 2 组（相反的时间表）。两个干预期各持续 5 周，中间有 5 周的清除期。 EMS干预组在血液透析期间对整个下肢骨骼肌进行治疗，持续5周，每周3次，每次30-40分钟。本研究的主要结果是干预后股四头肌等长肌力的变化。次要结局是身体机能、身体活动、日常生活活动困难、身体成分、认知功能、抑郁症状、生活质量、血液检测结果以及 EMS 治疗的临床安全性和可行性的变化。伦理与传播本研究已获得北里大学联合健康科学机构审查委员会/伦理委员会的批准。这项研究将在同行评审出版物和会议演示中进行报道。试验注册号UMIN000032501。
IntroductionThe phenomenon of population ageing is accompanied by increases in the number of elderly haemodialysis patients worldwide. The incidence of frailty is high in the haemodialysis population and is associated with poor clinical outcome. Although several interventions have been developed for use in general haemodialysis patients, the efficacy of such rehabilitation programmes in frail elderly patients on haemodialysis has not been elucidated. Here, we examined whether electrical muscle stimulation (EMS) would show beneficial effects in frail elderly patients on haemodialysis.Methods and analysisThis is a randomised, two-period, controlled crossover trial, which will enrol 20 patients. Haemodialysis patients aged ≥65 years and defined as frail (ie, Short Physical Performance Battery score 4–9), will be randomly assigned to either group 1 (EMS intervention beginning in treatment period I, followed by reallocation as controls in treatment period II after a 5-week washout period) or group 2 (opposite schedule) in a 1:1 ratio. The two intervention periods will last 5 weeks each with an intervening washout period of 5 weeks. In the EMS intervention group, the treatment will be applied to the skeletal muscle of the entire lower extremity for 5 weeks, three times/week for 30–40 min during haemodialysis. The primary outcome of this study is the change in quadriceps isometric strength after the interventions. The secondary outcomes are the changes in physical function, physical activity, difficulty in activities of daily living, body composition, cognitive function, depressive symptoms, quality of life, blood test results and the clinical safety and feasibility of EMS therapy.Ethics and disseminationThis study has been approved by the institutional review board/ethics committee of Kitasato University Allied Health Sciences. This study will be reported in peer reviewed publications and at conference presentations.Trial registration numberUMIN000032501.