Biemans Camille F M, Hartman Yvonne A W, Broers Suzanne, Pagen Sophie, Hendrickx Wendy, van Dongen Johanna M, Verschuren Olaf W, English Coralie, Veenhof Cindy, Visser-Meily Johanna M A, Pisters Martijn F
Department of Rehabilitation, Physiotherapy Science and Sport, University Medical Centre Utrecht Brain Centre, Utrecht, The Netherlands.
Department of Health Innovations and Technology, School of Health Sciences, Fontys University of Applied Sciences Physiotherapy, Eindhoven, The Netherlands.
BMJ Open. 2025 Jun 5;15(6):e094894. doi: 10.1136/bmjopen-2024-094894.
Striking the balance in 24-hour movement behaviour (sedentary behaviour, physical activity and sleep) is expected to reduce the risk of a new major cardiovascular event or death (MACE). We aim to determine the effectiveness and cost-effectiveness of the RISE () intervention by improving 24-hour movement behaviour for prevention of MACE and gaining quality-adjusted life years (QALYs) in community-dwelling people at risk with a first-ever stroke.
This assessor-blinded multicentre randomised controlled trial includes about 1000 participants with a first-ever stroke, of which 752 participants require secondary prevention based on their 24-hour movement behaviour. Participants will be randomly assigned to the experimental group (RISE intervention + usual care) or control (usual care) group. RISE is a 15-week blended care intervention: primary care physiotherapists coach people in their home setting using behaviour change techniques and the RISE eCoaching system. This system consists of: (1) an activity monitor, (2) a smartphone application that provides real-time feedback and contains e-learning modules and (3) a monitoring dashboard for the physiotherapist. A close relative of the participant is involved during the intervention to provide social support. The primary outcome is the effectiveness of the RISE intervention regarding the prevention of MACE measured at one year post randomisation using survival analysis comparing the experimental and control groups. Secondary outcomes include cost-effectiveness for MACE prevention and QALYs and changes in 24-hour movement behaviour over time using compositional data analysis.
Ethical approval is obtained from Medical Ethics Review Committee Utrecht, NedMec NL83940.000.23. Findings will be disseminated through international peer-reviewed journals and conferences. A sustainable 24-hour movement behaviour change is needed to gain long-term benefits of lowering MACE in patients with stroke. The RISE intervention offers this foundation by integrating behaviour change techniques, the RISE eCoaching system, involvement of participatory support and extensively trained RISE physiotherapists. Consequently, the RISE intervention is expected to be (cost-)effective compared with usual care, and hence, this study will offer a foundation for implementing the RISE intervention in standard poststroke care.
NCT06124248.
在24小时运动行为（久坐行为、体育活动和睡眠）中保持平衡有望降低发生新的重大心血管事件或死亡（MACE）的风险。我们旨在通过改善24小时运动行为来预防MACE并在首次发生中风的有风险的社区居民中获得质量调整生命年（QALY），从而确定RISE（）干预措施的有效性和成本效益。
这项评估者盲法多中心随机对照试验纳入了约1000名首次发生中风的参与者其中752名参与者根据其24小时运动行为需要二级预防。参与者将被随机分配到实验组（RISE干预+常规护理）或对照组（常规护理）。RISE是一项为期15周的综合护理干预措施：初级保健物理治疗师在家中使用行为改变技术和RISE电子辅导系统指导人们。该系统包括：（1）一个活动监测器（2）一个提供实时反馈并包含电子学习模块的智能手机应用程序（3）一个供物理治疗师使用的监测仪表板。参与者的一位近亲在干预期间参与提供社会支持。主要结局是在随机分组后一年使用生存分析比较实验组和对照组来衡量RISE干预对预防MACE的有效性。次要结局包括预防MACE的成本效益和QALY以及使用成分数据分析随时间变化的24小时运动行为。
已获得乌得勒支医学伦理审查委员会（NedMec NL83940.000.23）的伦理批准。研究结果将通过国际同行评审期刊和会议进行传播。需要实现可持续的24小时运动行为改变才能在中风患者中获得降低MACE的长期益处。RISE干预通过整合行为改变技术、RISE电子辅导系统、参与性支持以及经过广泛培训的RISE物理治疗师提供了这一基础。因此与常规护理相比RISE干预预计具有（成本）效益因此本研究将为在标准中风后护理中实施RISE干预提供基础。
NCT06124248。
