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运动干预对高血压患者血压和夜间血压下降的影响(END-HT):一项随机对照试验方案。

Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in HyperTensive Patients (END-HT): Protocol of a Randomized Controlled Trial.

机构信息

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.

Department of Computer Science and Engineering, The Chinese University of Hong Kong, Hong Kong.

出版信息

Am J Hypertens. 2021 Aug 9;34(7):753-759. doi: 10.1093/ajh/hpab019.

Abstract

BACKGROUND

Lack of decrease (≤10%) in systolic blood pressure (BP) during sleep, referred to as non-dipping (ND), independently predicts cardiovascular events and mortality. There has been no prospective and adequately powered randomized controlled trial (RCT) to determine whether exercise, when compared with standard treatment, can normalize ND in patients with hypertension (HT). Further, most patients do not sustain an exercise program by 12 months.

METHODS

A 2-arm, assessor-blinded RCT, involving 198 hypertensive Chinese patients who have ND will be conducted to evaluate the effectiveness of a combined exercise (aerobic exercise and resistance training) program to normalize ND. The combined exercise program, "exercise is medicine" (EIM), was developed to maintain exercise habit using a variety of techniques (e.g. 12-week exercise classes, mobile application, wrist trackers, self-scheduling, monitoring, regular feedback, and motivational interviewing). Eligible patients will be randomized to EIM plus usual care or to usual care in 1:1 ratio by stratified randomization according to age and sex. The randomization sequence is blinded to the investigators and allocation is disclosed only after valid consent. Ambulatory BP measurements will be performed at baseline, 3, and 12 months. The primary outcome is proportion of participants with ND at 3 months; secondary outcomes include proportion of participants with ND at 12 months, absolute BP values at 3 and 12 months. Exercise level will be detected by validated questionnaire and compared between 2 arms at 3 and 12 months.

CONCLUSION

The trial will examine the efficacy of treating ND and HT by an exercise program.

摘要

背景

睡眠期间收缩压(BP)无下降(≤10%),即非杓型(ND),可独立预测心血管事件和死亡率。目前尚无前瞻性、充分有力的随机对照试验(RCT)来确定与标准治疗相比,运动是否可以使高血压(HT)患者的 ND 正常化。此外,大多数患者在 12 个月内无法维持运动计划。

方法

将进行一项 2 臂、评估者盲法 RCT,涉及 198 例患有 ND 的高血压中国患者,以评估综合运动(有氧运动和抗阻训练)方案使 ND 正常化的有效性。综合运动方案“运动就是医学”(EIM)旨在使用多种技术(如 12 周运动课程、移动应用程序、腕带追踪器、自我安排、监测、定期反馈和动机访谈)来维持运动习惯。将根据年龄和性别分层随机将符合条件的患者随机分为 EIM 加常规护理组或常规护理组,比例为 1:1。随机序列对研究人员是盲态的,仅在获得有效同意后才披露分配情况。基线、3 个月和 12 个月时进行动态血压测量。主要结局是 3 个月时 ND 参与者的比例;次要结局包括 12 个月时 ND 参与者的比例、3 个月和 12 个月时的绝对 BP 值。将通过经过验证的问卷检测运动水平,并在 3 个月和 12 个月时比较 2 个组之间的运动水平。

结论

该试验将研究通过运动方案治疗 ND 和 HT 的疗效。

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