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个人活动追踪器(Fitbit Charge 2)对急性冠状动脉综合征后患者运动能力的效用[UP-STEP ACS试验]:一项随机对照试验方案

The utility of personal activity trackers (Fitbit Charge 2) on exercise capacity in patients post acute coronary syndrome [UP-STEP ACS Trial]: a randomised controlled trial protocol.

作者信息

Nogic Jason, Thein Paul Min, Cameron James, Mirzaee Sam, Ihdayhid Abdul, Nasis Arthur

机构信息

MonashHeart, Monash Health and Monash Cardiovascular Research Centre, 246 Clayton Road, Clayton, Melbourne, VIC, 3168, Australia.

出版信息

BMC Cardiovasc Disord. 2017 Dec 29;17(1):303. doi: 10.1186/s12872-017-0726-8.

Abstract

BACKGROUND

The benefits of physical activity and cardiovascular rehabilitation on the reduction of cardiovascular risk are well documented. Despite this, significant barriers and challenges remain in optimizing patient risk factors post acute coronary syndromes (ACS) and ensuring patient compliance. Consumer wearable personal activity trackers represent a cost effective and readily available technology that may aid in this endeavour.

METHODS

UP-STEP ACS is a prospective single-blinded, two-arm, parallel, randomized control trial with an aim to enrol 200 patients all undertaking cardiac rehabilitation. It will assess the affect that personal activity monitors have on change in exercise capacity in patients post acute coronary syndromes primarily measured by a six-minute walk test (6MWT). Secondary end points will be the improvement in other cardiovascular risk factors, namely; blood lipid and glucose levels, weight, waist circumference, along with mood, quality of life and cardiac rehabilitation adherence. Patients will be randomized to either receive a personal activity tracker or standard post hospital care during their index event. After the 8- week intervention period, patients will return for a clinical review and repeat of baseline assessments including the 6MWT.

DISCUSSION

The utility and impact on exercise capacity of personal activity trackers in patient's post-acute coronary syndrome has not been assessed. This study aims to add to the scientific evidence emerging regarding the clinical utility and validity of these devices in different patient population groups. If proven to be of benefit, these devices represent a cost effective, easily accessible technology that could aid in the reduction of cardiovascular events.

TRIAL REGISTRATION

The trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR). The registration number is ACTRN12617000312347 (28/02/2017).

摘要

背景

体育活动和心脏康复对降低心血管风险的益处已有充分记录。尽管如此,在优化急性冠状动脉综合征(ACS)后患者的风险因素以及确保患者依从性方面,仍存在重大障碍和挑战。消费者可穿戴式个人活动追踪器是一种具有成本效益且随时可用的技术,可能有助于实现这一目标。

方法

UP-STEP ACS是一项前瞻性单盲、双臂、平行随机对照试验,旨在招募200名均接受心脏康复的患者。该试验将评估个人活动监测器对急性冠状动脉综合征后患者运动能力变化的影响,主要通过六分钟步行试验(6MWT)进行测量。次要终点将是其他心血管风险因素的改善,即血脂和血糖水平、体重、腰围,以及情绪、生活质量和心脏康复依从性。在其首次发病期间,患者将被随机分为接受个人活动追踪器或标准出院后护理两组。在为期8周的干预期结束后,患者将返回进行临床复查,并重复包括6MWT在内的基线评估。

讨论

个人活动追踪器对急性冠状动脉综合征后患者运动能力的效用和影响尚未得到评估。本研究旨在补充有关这些设备在不同患者群体中的临床效用和有效性的科学证据。如果证明有益,这些设备代表了一种具有成本效益、易于获取的技术,可有助于减少心血管事件。

试验注册

该试验已在澳大利亚新西兰临床试验注册中心(ANZCTR)注册。注册号为ACTRN12617000312347(2017年2月28日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/669a/5747185/1668ab9938ab/12872_2017_726_Fig1_HTML.jpg

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