一项评估在斯洛伐克东部心血管保健中心患者中使用身体活动建议的随机对照试验：AWATAR 研究的研究设计和原理。
A randomized controlled trial to evaluate utilization of physical activity recommendations among patients of cardiovascular healthcare centres in Eastern Slovakia: study design and rationale of the AWATAR study.
机构信息
Institute of Physical Education and Sport, P. J. Safarik University, Ondavska 21, 040 11, Kosice, Slovakia.
Graduate School Kosice Institute for Society and Health, Faculty of Medicine, P. J. Safarik University, Trieda SNP 1, 040 11, Kosice, Slovakia.
出版信息
BMC Public Health. 2018 Apr 4;18(1):454. doi: 10.1186/s12889-018-5349-1.
BACKGROUND
Guidelines on modifiable risk factors regarding cardiological patients are poorly implemented in clinical practice perhaps due to low health literacy. Several digital tools for improving lifestyle and behavioural intervention were developed. Our primary aim is to evaluate the effectiveness of a digital exercise prescription tool on the adherence to physical activity recommendations among patients with cardiovascular diseases.
METHODS
A randomized controlled trial will be realized in cooperation with Cardiovascular Health Centres in Eastern Slovakia. Patients recruited through their cardiologists, will be randomised at 1:1 ratio to the three-months' experimental condition or control condition. The experimental group will receive standard lifestyle consultation leading to individually optimized prescription of physical activity. The control group will receive standard, usual-cardio-care lifestyle counselling, also in the domain of physical activity. The digital system will be used for optimized exercise prescription. The primary outcome is a change in the patient's adherence to exercise recommendations. Data will be collected in both groups prior to consultation and after 3 months.
DISCUSSION
This study protocol presents background and design of a randomized control trial to investigate the effectiveness of a digital system-provide exercise prescription tool on the adherence to physical activity recommendations. An optimized exercise prescription that better reflects patient's diagnosis, comorbidities and medication can have a significant impact on secondary prevention of cardiovascular disease. This trial can provide important evidence about the effectiveness of digital exercise guidance in everyday practice of cardiovascular healthcare.
TRIAL REGISTRATION
The study was registered on 1st November, 2017 and is available online at ClinicalTrials.gov (ID: NCT03329053 ).
背景
针对心血管病患者的可修正风险因素指南在临床实践中实施效果不佳，这可能是由于健康素养水平较低所致。目前已经开发出了几种用于改善生活方式和行为干预的数字工具。我们的主要目的是评估数字运动处方工具在提高心血管疾病患者对体力活动建议的依从性方面的有效性。
方法
该研究将与斯洛伐克东部的心血管健康中心合作开展一项随机对照试验。通过他们的心脏病专家招募的患者将以 1:1 的比例随机分为三个月的实验组或对照组。实验组将接受标准的生活方式咨询，从而制定出针对个体的最佳体力活动处方。对照组将接受标准的、通常的心脏保健生活方式咨询，同样是在体力活动方面。数字系统将用于优化运动处方。主要结局是患者对运动建议的依从性变化。将在咨询前和 3 个月后在两组中收集数据。
讨论
本研究方案介绍了一项随机对照试验的背景和设计，以调查数字系统提供的运动处方工具对体力活动建议的依从性的有效性。能够更好地反映患者诊断、合并症和用药情况的优化运动处方，对心血管疾病的二级预防可能会产生重大影响。这项试验可以为数字运动指导在心血管保健日常实践中的有效性提供重要证据。
试验注册
该研究于 2017 年 11 月 1 日注册，并可在 ClinicalTrials.gov 上在线获取（编号：NCT03329053）。
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