Design and methods of CYCLE-HD: improving cardiovascular health in patients with end stage renal disease using a structured programme of exercise: a randomised control trial
Design and methods of CYCLE-HD: improving cardiovascular health in patients with end stage renal disease using a structured programme of exercise: a randomised control trial
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DOI：
10.1186/s12882-016-0294-7
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发表时间：
2016-07-08
期刊：
影响因子：
2.3
通讯作者：
Burton, J. O.
中科院分区：
文献类型：
--
作者：
Graham-Brown, M. P. M.;March, D. S.;Burton, J. O.
背景资料：有新的证据表明，运动训练可以积极影响血液透析患者中与心源性猝死相关的几个心血管风险因素。本研究的主要目的是评估的影响，透析中运动程序对左心室mass.Method和设计：前瞻性，随机分组开放标签盲终点临床试验在130例终末期肾病血液透析患者。患者将以1：1的比例随机分配至1）透析期间每周三次至少30分钟的连续循环或2）标准治疗。主要结局是6个月时通过心脏MRI（CMR）评估的左心室质量变化。为了在80%把握度下检测到组间LV质量差异15 g，每组需要65例患者的样本量。次要结局指标包括心律异常、左心室容积和射血分数、身体功能指标、人体测量指标、生活质量和炎症标志物，并在3个月时对某些指标进行中期评估。本研究将检验透析中运动程序导致左心室质量消退的假设，终末期肾病的一个重要的非传统心血管危险因素。这将首次使用CMR进行评估。我们还将使用一些次要终点来评估透析中运动计划的有效性、可行性和安全性。我们预计，积极的结果将导致更多的患者接受既定的透析内治疗计划，并在国内和国际上制定新的计划。
Background: There is emerging evidence that exercise training could positively impact several of the cardiovascular risk factors associated with sudden cardiac death amongst patients on haemodialysis. The primary aim of this study is to evaluate the effect of an intradialytic exercise programme on left ventricular mass.Method and design: Prospective, randomised cluster open-label blinded endpoint clinical trial in 130 patients with end stage renal disease on haemodialysis. Patients will be randomised 1:1 to either 1) minimum of 30 min continuous cycling thrice weekly during dialysis or 2) standard care. The primary outcome is change in left ventricular mass at 6 months, assessed by cardiac MRI (CMR). In order to detect a difference in LV mass of 15 g between groups at 80 % power, a sample size of 65 patients per group is required. Secondary outcome measures include abnormalities of cardiac rhythm, left ventricular volumes and ejection fraction, physical function measures, anthropometric measures, quality of life and markers of inflammation, with interim assessment for some measures at 3 months.Discussion: This study will test the hypothesis that an intradialytic programme of exercise leads to a regression in left ventricular mass, an important non-traditional cardiovascular risk factor in end stage renal disease. For the first time this will be assessed using CMR. We will also evaluate the efficacy, feasibility and safety of an intradialytic exercise programme using a number of secondary end-points. We anticipate that a positive outcome will lead to both an increased patient uptake into established intradialytic programmes and the development of new programmes nationally and internationally.