Key result
RISE trial tests 15-week blended care to reduce 1-year MACE after first-ever stroke.
Why the study?
A sustainable 24-hour movement behaviour change is needed to gain long-term benefits of lowering MACE in patients with a first-ever stroke, but effective interventions are lacking.
Does the RISE intervention added to usual care reduce MACE in community-dwelling people with a first-ever stroke?
RCT (n=1,000)
assessor-blinded
randomly assigned
Yes
Does the RISE intervention added to usual care reduce MACE in community-dwelling people with a first-ever stroke?
The RISE trial will evaluate whether a 15-week blended care intervention targeting 24-hour movement behavior reduces MACE in patients with a first-ever stroke.
INTRODUCTION: ) 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT06124248.
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Biemans et al. (2025) conducted an RCT in first-ever stroke (n=1,000). RISE intervention vs. usual care was evaluated on prevention of MACE measured at one year post randomisation. The RISE trial is designed to evaluate whether a 15-week blended care intervention reduces major adverse cardiovascular events at 1 year among 1000 patients with a first-ever stroke.
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