Title: Development and evaluation of strategies to reduce sedentary behaviour in patients after stroke and improve outcomes
Funder: Department of Health and Social Care

Abstract: Aims and objectives We seek to enhance health and disability outcomes for stroke survivors through the development and evaluation of strategies to both reduce overall time spent sedentary and break up long bouts of sedentary behaviour. Research questions relate to identification of existing evidence; exploration of capabilities, opportunities and motivation related to sedentary behaviour after stroke; determining whether an intervention developed using principles of co-production is feasible and whether trial design issues can be addressed before assessing the clinical and cost-effectiveness of the intervention. Background and rationale There is increasing evidence that sedentary behaviour has a detrimental effect on health and well being independent of the level of moderate to vigorous physical activity someone might undertake. At least 1.2M people living in England have had a stroke, and longer-term outcomes are poor for many. Survivors of stroke are particularly sedentary compared to age-matched controls. Negative effects of sedentary behaviour include reduced physical function, increased symptoms of depression and anxiety, increased mortality and elevated markers associated with cardiovascular risk. Our research is focused on the reduction of levels of sedentary behaviour: in terms of total amounts of time and the number of extended periods of time spent sitting/lying to provide a relatively low cost solution to improving outcomes after stroke. The applicant team are the leading proponents of sedentary behaviour research in stroke. Research plan We propose to develop and evaluate a complex intervention to reduce sedentary behaviour after stroke. We will develop the intervention with appropriate implementation plans through a co-production approach incorporating behaviour change principles. Workstream 1 Update of the quantitative and qualitative evidence relating to sedentary behaviour through systematic review of the literature. The literature will be analysed to identify behaviour change techniques contributing to effectively reducing sedentary behaviour. Workstream 2 Observations (in hospital and in the community) and semi-structured interviews in two stroke services will be undertaken to inform the co-production process. Interviews with patients and their carers, at three and six months post-stroke (approximately 10 at each time point, in each service), and with members of the multi-disciplinary team will explore the capability, opportunity and motivation to address sedentary behaviours from their perspectives. Interviews will be analysed using Framework Analysis. Workstream 3 Informed by previous workstreams and behaviour change principles, development of an agreed intervention to reduce sedentary behaviour through use of co-production principles in two stroke services. Workstream 4 A case study and action research approach will be used in three services to clarify: content; methods of delivery of the intervention; fidelity assessment and capture learning from, and acceptability to, staff and participating stroke survivors. Trial procedures relating to patient eligibility criteria, recruitment process and data collection will also be clarified. It is anticipated that 15 patients (and carers if available) will be recruited in each service. Workstream 5 A multicentre cluster Randomised Controlled Trial evaluating the clinical and cost-effectiveness of the intervention incorporating an internal pilot phase and embedded process evaluation. Primary outcome: WHODAS 2.0 at 12 months following participant recruitment. 34 stroke services each recruiting 34 patients will result in 1156 patients overall and provide 90% power at 5% significance level to detect moderate effect size of 0.3 in WHODAS 2.0 questionnaire. Key secondary outcome: mean daily time spent sitting measured by activity monitor (activPAL) at 12 months. All outcomes will be assessed at baseline, 6, 12 and 24 months after recruitment. The outcomes of: mood; depression; quality of life; total major vascular events; CVD risk factors; death; hospital admission and institutionalization, use and costs of health and social care services will also be collected at all time points. Data on fatigue and number of falls will also be obtained. We will use a range of methods including documentary analysis, non-participant observation, and semi-structured interviews in an embedded process evaluation in four intervention and four control services. Projected outputs & dissemination plans The research will generate an internationally leading dataset on the volume and patterns of sedentary behaviour in stroke survivors, with linked health outcomes, combined with a comprehensive and detailed intervention protocol suitable for a range of abilities post-stroke. This will place the UK at the forefront of this research agenda and will enable UK stroke care to align with recent international guidelines on physical activity and sedentary behaviour. The dissemination strategy will include: a website; newsletters; and social media. Results will be disseminated through lay, professional and commissioning forums and made available to all participants. Benefits to patients and the NHS. An intervention to reduce sedentary behaviour has the potential for substantial impact on functioning, health and well being outcomes for the large population of post-stroke survivors at relatively low cost. It may also result in reduction of scarce NHS resources. Work undertaken will inform interventions in other similar conditions (and for older people generally).

Lay abstract: Time spent in sedentary behaviour (sitting/lying down) has recently emerged as an important topic. Too much time spent in sedentary behaviours is linked with ill health and mortality. This seems to be independent of physical activity, a short burst of activity such as an exercise class will not offset the detrimental health effects of many hours sitting. Survivors of stroke are among the most sedentary individuals in the population, spending up to 80% of their waking day sitting or lying down. Interventions to reduce sitting time have enormous potential, would be low cost and may be more achievable than a structured exercise programme, particularly in stroke survivors afraid of another stroke or falling. Our focus is on reducing sitting time in survivors of stroke in their own homes once they have been discharged from hospital and therapy services. However, to achieve this we feel it is important that stroke survivors are appropriately informed and supported in reducing sedentary behaviour from the time of their stroke, learning techniques which they can continue at home when no longer in receipt of therapy. We propose 5 workstreams (WS). We will continue to update reviews of previous and current research to ensure we are up to date with current thinking (WS1). Working with two stroke services we will interview patients and their carers (if available), at home, a few months after their stroke, to explore their thoughts and perceptions on sedentary behaviour, and what might help or hinder this (WS2). We will also interview staff, and observe what happens on stroke units and during therapy sessions in patients homes. In WS3, through a method called co-production, ways of addressing sedentary behaviour will be developed by joint work between stroke survivors, their carers and healthcare professionals. Joint patient and professional working groups will be formed, research evidence (WS1) and information from WS2 will be discussed and through a series of meetings, ideas and action plans for reducing time spent sitting/lying, (the intervention) will be developed. We will test out this intervention in three stroke services in WS4, including approximately 15 stroke survivors in each service. We will interview staff, patients and carers, to determine their views on the ease of implementing and taking part in the intervention. We will also assess: whether we can recruit enough patients; whether the outcome measures, are acceptable; and whether there are any unforeseen problems. Finally, in WS5, we plan to undertake a large randomised trial in which half the stroke services will be randomised to undertake the intervention and half will continue with care they currently provide to determine whether this intervention can effectively reduce sedentary behaviour, improve health outcomes and demonstrate value for money.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: STROKE