Oral Presentation Smart Strokes Annual Scientific Meeting 2025

Secondary prevention by striking the balance in 24-hour movement behaviour by empowering people at risk with a stroke: Rationale and Design of the RISE intervention randomised controlled trial (123131)

Camille F.M. Biemans 1 2 3 , Yvonne A.W. Hartman 1 2 3 , Suzanne Broers 1 3 , Sophie Pagen 1 2 3 , Wendy Hendrickx 1 2 3 , RISE study group 1 , Johanna M. van Dongen 4 5 , Olaf W. Verschuren 2 6 , Coralie English 7 , Cindy Veenhof 1 8 , Johanna M.A. Visser-Meily 1 6 , Martijn F. Pisters 1 2 3
  1. Department of Rehabilitation, Physiotherapy Science & Sport, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
  2. Research Group Empowering Healthy Behaviour, department of Health Innovations and Technology, Fontys University of Applied Sciences, Eindhoven, The Netherlands
  3. Center for Physiotherapy Research and Innovation in Primary Care, Julius Health Care Centers, Utrecht, The Netherlands
  4. Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands
  5. Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health, Amsterdam, The Netherlands
  6. Center of Excellence for Rehabilitation Medicine, Brain Center, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht, The Netherlands
  7. Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia
  8. Research Group Innovation of Human Movement Care, HU University of Applied Sciences Utrecht, Utrecht, The Netherlands

Introduction

Striking the balance in 24-hour movement behaviour (sedentary behaviour, physical activity and sleep) is expected to reduce the risk of recurrent major cardiovascular event or death (MACE). We aim to determine the (cost-)effectiveness of the RISE intervention for secondary prevention of MACE in community dwelling people at risk with first-ever stroke by improving 24-hour movement behaviour.


Methods

This assessor-blinded multicentre randomised controlled trial includes 1000 participants with first-ever stroke, of whom 752 high-risk participants (who are sedentary and inactive based on their 24-hour movement behaviour) are randomised to the experimental group (RISE intervention) or control (usual care) group. RISE is a 15 week-blended behavioural intervention: 120 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 is involved during the intervention to provide participatory support. This intervention was co-designed with stroke survivors.

The primary outcome is effectiveness of the RISE intervention regarding prevention of MACE measured at one year post-randomisation using survival analysis comparing experimental and control group. Secondary outcomes include cost-effectiveness for MACE prevention and QALYs and changes in 24-hour movement behaviour over time using Compositional Data Analysis.

Conclusion

This study offers the foundation of implementation of the RISE intervention in post-stroke care. The integration of behaviour change techniques, the RISE eCoaching system, participatory support, and extensively trained physiotherapists is expected to establish a sustainable movement behavioural change and thereby contribute to the prevention of MACE

Relevance

A sustainable 24-hour movement behaviour change is needed to lower MACE in patients with stroke. Assessing the (cost-)effectiveness of the RISE intervention will offer a foundation for implementation in standard post-stroke care.