Maddison Ralph, Rawstorn Jonathan C, Rolleston Anna, Whittaker Robyn, Stewart Ralph, Benatar Jocelyne, Warren Ian, Jiang Yannan, Gant Nicholas
National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.
BMC Public Health. 2014 Nov 28;14:1236. doi: 10.1186/1471-2458-14-1236.
Exercise is an essential component of contemporary cardiac rehabilitation programs for the secondary prevention of coronary heart disease. Despite the benefits associated with regular exercise, adherence with supervised exercise-based cardiac rehabilitation remains low. Increasingly powerful mobile technologies, such as smartphones and wireless physiological sensors, may extend the capability of exercise-based cardiac rehabilitation by enabling real-time exercise monitoring for those with coronary heart disease. This study compares the effectiveness of technology-assisted, home-based, remote monitored exercise-based cardiac rehabilitation (REMOTE) to standard supervised exercise-based cardiac rehabilitation in New Zealand adults with a diagnosis of coronary heart disease.
METHODS/DESIGN: A two-arm, parallel, non-inferiority, randomised controlled trial will be conducted at two sites in New Zealand. One hundred and sixty two participants will be randomised at a 1:1 ratio to receive a 12-week program of technology-assisted, home-based, remote monitored exercise-based cardiac rehabilitation (intervention), or an 8-12 program of standard supervised exercise-based cardiac rehabilitation (control).The primary outcome is post-treatment maximal oxygen uptake (V̇O2max). Secondary outcomes include cardiovascular risk factors (blood lipid and glucose concentrations, blood pressure, anthropometry), self-efficacy, intentions and motivation to be active, objectively measured physical activity, self-reported leisure time exercise and health-related quality of life. Cost information will also be collected to compare the two modes of delivery. All outcomes are assessed at baseline, post-treatment, and 6 months, except for V̇O2max, blood lipid and glucose concentrations, which are assessed at baseline and post-treatment only.
This novel study will compare the effectiveness of technology-supported exercise-based cardiac rehabilitation to a traditional supervised approach. If the REMOTE program proves to be as effective as traditional cardiac rehabilitation, it has potential to augment current practice by increasing access for those who cannot utilise existing services.
Australian New Zealand Clinical Trials RegistryStudy ID number: ACTRN12614000843651. Registered 7 August 2014.
运动是当代冠心病二级预防心脏康复计划的重要组成部分。尽管定期运动有益,但基于运动的心脏康复监督治疗的依从性仍然很低。日益强大的移动技术,如智能手机和无线生理传感器,可能通过为冠心病患者提供实时运动监测来扩展基于运动的心脏康复能力。本研究比较了技术辅助、居家、远程监测的基于运动的心脏康复(REMOTE)与标准监督的基于运动的心脏康复对新西兰确诊冠心病成年人的有效性。
方法/设计:将在新西兰的两个地点进行一项双臂、平行、非劣效性随机对照试验。162名参与者将按1:1的比例随机分组,接受为期12周的技术辅助、居家、远程监测的基于运动的心脏康复计划(干预组),或为期8 - 12周的标准监督的基于运动的心脏康复计划(对照组)。主要结局是治疗后最大摄氧量(V̇O2max)。次要结局包括心血管危险因素(血脂和血糖浓度、血压、人体测量学指标)、自我效能感、积极活动的意愿和动机、客观测量的身体活动、自我报告的休闲时间运动以及健康相关生活质量。还将收集成本信息以比较两种治疗方式。除V̇O2max、血脂和血糖浓度仅在基线和治疗后评估外,所有结局均在基线、治疗后和6个月时评估。
这项新研究将比较技术支持的基于运动的心脏康复与传统监督方法的有效性。如果REMOTE计划被证明与传统心脏康复一样有效,它有可能通过增加无法利用现有服务的人群的可及性来改进当前的治疗方法。
澳大利亚新西兰临床试验注册中心研究识别号:ACTRN12614000843651。于2014年8月7日注册。