Thompson Stephanie, Wiebe Natasha, Gyenes Gabor, Davies Rachelle, Radhakrishnan Jeyasundar, Graham Michelle
Division of Nephrology and Immunology, 11-112R CSB, 152 University Campus NW, University of Alberta, 11-112 Clinical Sciences Building, Edmonton, AB, T6G 2G3, Canada.
Department of Cardiology, Mackenzie Health Science Centre, 8440-112 Street, Edmonton, AB, T6G 2B7, Canada.
Trials. 2019 Feb 8;20(1):109. doi: 10.1186/s13063-019-3235-5.
The prevalence of hypertension among people with chronic kidney disease is high with over 60% of people not attaining recommended targets despite taking multiple medications. Given the health and economic implications of hypertension, additional strategies are needed. Exercise is an effective strategy for reducing blood pressure in the general population; however, it is not known whether exercise would have a comparable benefit in people with moderate to advanced chronic kidney disease and hypertension.
This is a parallel-arm trial of adults with hypertension (systolic blood pressure greater than 130 mmHg) and an estimated glomerular filtration rate of 15-45 ml/min 1.73 m. A total of 160 participants will be randomized, with stratification for estimated glomerular filtration rate, to a 24-week, aerobic-based exercise intervention or enhanced usual care. The primary outcome is the difference in 24-h ambulatory systolic blood pressure after 8 weeks of exercise training. Secondary outcomes at 8 and 24 weeks include: other measurements of blood pressure, aortic stiffness (pulse-wave velocity), change in the Defined Daily Dose of anti-hypertensive drugs, medication adherence, markers of cardiovascular risk, physical fitness (cardiopulmonary exercise testing), 7-day accelerometry, quality of life, and adverse events. The effect of exercise on renal function will be evaluated in an exploratory analysis. The intervention is a thrice-weekly, moderate-intensity aerobic exercise supplemented with isometric resistance exercise delivered in two phases. Phase 1: supervised, facility-based, weekly and home-based sessions (8 weeks). Phase 2: home-based sessions (16 weeks).
To our knowledge, this study is the first trial designed to provide a precise estimate of the effect of exercise on blood pressure in people with moderate to severe CKD and hypertension. The findings from this study should address a significant knowledge gap in hypertension management in CKD and inform the design of a larger study on the effect of exercise on CKD progression.
ClinicalTrials.gov, ID: NCT03551119 . Registered on 11 June 2018.
慢性肾脏病患者中高血压的患病率很高，尽管服用了多种药物，但仍有超过60%的患者未达到推荐目标。鉴于高血压对健康和经济的影响，需要额外的策略。运动是降低普通人群血压的有效策略；然而，运动对中度至重度慢性肾脏病合并高血压患者是否具有类似的益处尚不清楚。
这是一项针对高血压（收缩压大于130 mmHg）且估计肾小球滤过率为15 - 45 ml/min/1.73 m²的成年人的平行组试验。总共160名参与者将按估计肾小球滤过率分层，随机分为24周的有氧运动干预组或强化常规护理组。主要结局是运动训练8周后24小时动态收缩压的差异。8周和24周时的次要结局包括：其他血压测量值、主动脉僵硬度（脉搏波速度）、抗高血压药物规定日剂量的变化、药物依从性、心血管风险标志物、体能（心肺运动试验）、7天加速度计测量、生活质量和不良事件。将在探索性分析中评估运动对肾功能的影响。干预措施为每周三次的中等强度有氧运动，并辅以等长抗阻运动，分两个阶段进行。第1阶段：在设施内进行监督，每周一次并在家中进行训练（8周）。第2阶段：在家中进行训练（16周）。
据我们所知，本研究是第一项旨在精确估计运动对中度至重度慢性肾脏病合并高血压患者血压影响的试验。本研究的结果应填补慢性肾脏病高血压管理方面的重大知识空白，并为设计一项关于运动对慢性肾脏病进展影响的更大规模研究提供信息。
ClinicalTrials.gov，标识符：NCT03551119。于2018年6月11日注册。
