Development and evaluation of strategies to reduce sedentary behaviour in stroke survivors and improve outcomes: the RECREATE research programme including pilot cRCT

Background There is increasing evidence that sedentary behaviour has a detrimental effect on health and well-being. At least 1.2 million people living in England have had a stroke, and longer-term outcomes are poor for many. Stroke survivors are particularly sedentary compared to age-matched controls.

Objective(s) We sought to enhance health outcomes for stroke survivors through the development and evaluation of strategies to reduce sedentary behaviour. Research questions related 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 coproduction was feasible and whether trial design issues could be addressed before assessing the clinical and cost-effectiveness of the intervention. A pragmatic definitive trial to assess the developed intervention was planned; due to the COVID-19 pandemic, the trial was reduced to an external pilot trial.

Design and methods Five overlapping workstreams were undertaken:

Systematic review to collate the quantitative and qualitative evidence relating to sedentary behaviour in adults including survivors of stroke.

Observations and semistructured interviews in two stroke services to inform the coproduction process and explore the capability, opportunity and motivation to address sedentary behaviours.

Development of an intervention to reduce sedentary behaviour through use of coproduction principles in Yorkshire and Scotland.

A single-arm feasibility trial in three services to refine the developed intervention and clarify trial procedures.

A multicentre external pilot cluster randomised controlled trial evaluating the intervention incorporating embedded process and economic evaluations.

Setting and participants Stroke services (inclusive of primary, secondary and community care provision) across England and Scotland. Participants were stroke survivors and their carers, and healthcare professionals in the included stroke services.

Intervention An intervention to reduce sedentary behaviour was coproduced in workstream 3, informed by information obtained in workstream 1 and workstream 2. In workstream 4, groups (healthcare professionals, stroke survivors and researchers) were established in three stroke services that led implementation in their service and contributed to the iterative refinement of the intervention. The intervention (called Get Set Go) is a whole-service intervention designed to be implemented and embedded within routine practice. Delivery commences in the inpatient stroke unit setting and continues into the community for at least 12 weeks post discharge. The intervention focuses on: (1) educating staff and stroke survivors; (2) preparing and enabling staff to support and encourage stroke survivors to stand and move more in everyday stroke care; (3) encouraging stroke survivors to monitor their own standing and moving,

Main outcome measures The primary outcome was stroke survivor self-reported Nottingham Extended Activities of Daily Living scale at 12 months post registration. The key secondary outcome was mean daily sedentary time (minutes) at 12 months post registration using activity monitor (activPAL) data.

Data sources Literature reviews; observations and semistructured interviews in stroke services; feasibility and trial outcomes.

Results Workstream 1: two quantitative (n = 85 studies and n = 30, respectively) and two qualitative systematic reviews (n = 30, n = 17) were undertaken and published.

Workstream 2: observational (in inpatient and community settings) and interview work was undertaken in two sites (Yorkshire and Scotland).

Workstream 3: five coproduction workshops were conducted concurrently in Edinburgh and Yorkshire (n = 43 participants), and a provisional intervention was developed.

Workstream 4: implementation groups in three services, who operationalised and implemented the intervention. Trial procedures were refined and a concurrent qualitative data collection guided adaptation of the intervention.

Workstream 5: 15 English stroke services were randomised (n = 8 treatment, n = 7 control) and recruited 334 stroke survivors (n = 249 retained at 12-month follow-up). Results did not indicate potential effectiveness of Get Set Go compared with usual care [adjusted mean difference in Nottingham Extended Activities of Daily Living scale at 12 months (95% confidence interval) p = −1.76 (−7.63 to 4.25), p = 0.530]. No significant differences between arms were found in secondary outcomes. The exploratory findings from this external pilot study suggest that the Get Set Go intervention is unlikely to be cost-effective.

Limitations Due to coronavirus disease discovered in 2019, workstream 5 was reduced to become an external pilot trial with reduced 24-month follow-up. This trial was therefore not powered to detect definitive outcomes.

Conclusions Participants appreciated the relevance of the work and components of the intervention developed. Implementing service change in the inpatient setting is challenging.

Future work Work is ongoing to tailor the intervention to different patient types based on a secondary analysis of the patient interview data using ideal-type analysis methods. Development of a consistent messaging strategy relating to sedentary behaviour and survivors of stroke is required.

Trial registration This trial is registered as ISRCTN 12246326, registered on 7 August 2019 and ISRCTN82280581, registered on 1 April 2020.

Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0615-20019) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 14. See the NIHR Funding and Awards website for further award information.