Intervention to reduce sedentary behaviour and improve outcomes after stroke (Get Set Go): a study protocol for the process evaluation of a pilot cluster randomised controlled trial (RECREATE).

INTRODUCTION: Stroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB ('Get Set Go') will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes. METHODS AND ANALYSIS: This pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model. ETHICS AND DISSEMINATION: The study was approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 19/YH/0403). Findings will be disseminated via peer review publications, and national and international conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN82280581.

RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations.

INTRODUCTION: Sedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are consistently reported as being more sedentary than healthy age-matched controls, spending more hours sedentary daily and sustaining longer unbroken bouts of sedentary time. An evidence-based and clinically feasible intervention ('Get Set Go') was developed. A pragmatic definitive trial to evaluate Get Set Go was planned; however, due to the unprecedented effects of the COVID-19 pandemic on National Health Service (NHS) services this study was reduced in size and scope to become an external pilot trial. We report the protocol for this external pilot trial, which aims to undertake a preliminary exploration of whether Get Set Go is likely to improve ability to complete extended activities of daily living in the first year post-stroke and inform future trial designs in stroke rehabilitation. METHODS AND ANALYSIS: This study is a pragmatic, multicentre, two-arm, external pilot cluster randomised controlled trial with embedded process and economic evaluations. UK-based stroke services will be randomised 1:1 to the intervention (usual care plus Get Set Go) or control (usual care) arm. Fifteen stroke services will recruit 300-400 stroke inpatient and carer participants, with follow-up at 6, 12 and 24 months. The proposed primary endpoint is stroke survivor self-reported Nottingham Extended Activities of Daily Living scale at 12 months. Endpoint analyses will be exploratory and provide preliminary estimates of intervention effect. The process evaluation will provide valuable information on intervention fidelity, acceptability and how it can be optimised. ETHICS AND DISSEMINATION: The study has been approved by Yorkshire and The Humber - Bradford-Leeds Research Ethics Committee (Ref: 19/YH/0403). Results will be disseminated through journal publications and conference presentations. TRIAL REGISTRATION NUMBER: This trial was registered prospectively on 01 April 2020 (ISRCTN ref: ISRCTN82280581).

Protocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS).

RATIONALE: To address unmet needs, electronic messages to support person-centered goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited. HYPOTHESIS: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomization. METHODS AND DESIGN: Multicenter, double-blind, randomized controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalized, goal-centered, and administrative electronic messages, while the control group only receive administrative messages. The trial includes a process evaluation, assessment of treatment fidelity, and an economic evaluation. Participants: Confirmed stroke (modified Rankin Score: 0-4), aged ≥18 years with internet/mobile phone access, discharged directly home from hospital. Randomization: 1:1 computer-generated, stratified by age and baseline disability. Outcomes assessments: Collected at 90 days and 12 months following randomization. OUTCOMES: Primary outcomes include hospital emergency presentations/admissions within 90 days of randomization. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months. Sample size: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of α = 0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n = 668 are obtained, with maximum sample capped at 1100. DISCUSSION: We will provide new evidence on the potential effectiveness, implementation, and cost-effectiveness of a tailored eHealth intervention for survivors of stroke.

A qualitative study of sedentary behaviours in stroke survivors: non-participant observations and interviews with stroke service staff in stroke units and community services.

PURPOSE: Sedentary behaviour (SB) is associated with negative health outcomes and is prevalent post-stroke. This study explored SB after stroke from the perspective of stroke service staff. METHODS: Qualitative mixed-methods study. Non-participant observations in two stroke services (England/Scotland) and semi-structured interviews with staff underpinned by the COM-B model of behaviour change. Observations were analysed thematically; interviews were analysed using the Framework approach. RESULTS: One hundred and thirty-two observation hours (October - December 2017), and 31 staff interviewed (January -June 2018). Four themes were identified: (1) Opportunities for staff to support stroke survivors to reduce SB; (2) Physical and psychological capability of staff to support stroke survivors to reduce SB; (3) Motivating factors influencing staff behaviour to support stroke survivors to reduce SB; (4) Staff suggestions for a future intervention to support stroke survivors to reduce SB. CONCLUSIONS: Staff are aware of the consequences of prolonged sitting but did not relate to SB. Explicit knowledge of SB was limited. Staff need training to support stroke survivors to reduce SB. Sedentary behaviour in the community was not reported to change markedly, highlighting the need to engage stroke survivors in movement from when capable in hospital, following through to home.Implications for rehabilitationStroke survivor sedentary behaviour is influenced, directly and indirectly, by the actions and instructions of stroke service staff in the inpatient and community setting.The built and social environment, both in the inpatient and community settings, may limit opportunities for safe movement and can result in stroke survivors spending more time sedentary.Stroke service staff appreciate the benefit of encouraging stroke survivors to stand and move more, if it is safe for them to do so.Staff would be amenable to encourage stroke survivors to reduce sedentary behaviour, provided they have the knowledge and resources to equip them to support this.

Protocol for the economic evaluation of the InTENSE program for rehabilitation of chronic upper limb spasticity.

BACKGROUND: Assessment of the costs of care associated with chronic upper-limb spasticity following stroke in Australia and the potential benefits of adding intensive upper limb rehabilitation to botulinum toxin-A are key objectives of the InTENSE randomised controlled trial. METHODS: Recruitment for the trial has been completed. A total of 139 participants from 6 stroke units across 3 Australian states are participating in the trial. A cost utility analysis will be undertaken to compare resource use and costs over 12 months with health-related quality of life outcomes associated with the intervention relative to a usual care comparator. A cost effectiveness analysis with the main clinical measure of outcome, Goal Attainment Scaling, will also be undertaken. The primary outcome measure for the cost utility analysis will be the incremental cost effectiveness ratio (ICER) generated from the incremental cost of the intervention as compared to the incremental benefit, as measured in quality adjusted life years (QALYs) gained. The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year (QALY) gains for the intervention relative to usual care using area-under the curve methods. DISCUSSION: The results of the economic evaluation will provide evidence of the total costs of care for patients with chronic upper limb spasticity following stroke. It will also provide evidence for the cost-effectiveness of adding evidence-based movement therapy to botulinum toxin-A as a treatment, providing important information for health system decision makers tasked with the planning and provision of services.

Effect of adding upper limb rehabilitation to botulinum toxin-A on upper limb activity after stroke: Protocol for the InTENSE trial.

Rationale Although clinical practice guidelines recommend that management of moderate to severe spasticity include the use of botulinum toxin-A in conjunction with therapy, there is currently no evidence to support the addition of therapy. Aims To determine the effect and cost-benefit of adding evidence-based movement training to botulinum toxin-A. Sample size estimate A total of 136 participants will be recruited in order to be able to detect a between-group difference of seven points on the Goal Attainment Scale T-score with 80% power at a two-tailed significance level of 0.05. Methods and design The InTENSE trial is a national, multicenter, Phase III randomized trial with concealed allocation, blinded assessment and intention-to-treat analysis. Stroke survivors who are scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke greater than three months ago, who have completed formal rehabilitation and have no significant cognitive impairment will be randomly allocated to receive botulinum toxin-A plus evidence-based movement training or botulinum toxin-A alone. Study outcomes The primary outcomes are goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at three months (end of intervention) and at 12 months (beyond the intervention). Secondary outcomes are spasticity, range of motion, strength, pain, burden of care and health-related quality of life. Direct costs, personal costs and health system costs will be collected at 12 months. Discussion The results of the InTENSE trial are anticipated to directly influence intervention for moderate to severe spasticity after stroke. Trial Registration ANZCTR12615000616572.

Alternating Sitting and Standing Increases the Workplace Energy Expenditure of Overweight Adults.

BACKGROUND: To determine whether alternating bouts of sitting and standing at work influences daily workplace energy expenditure (EE). METHODS: Twenty-three overweight/obese office workers (mean ± SD; age: 48.2 ± 7.9 y, body mass index: 29.6 ± 4.0 kg/m2) undertook two 5-day experimental conditions in an equal, randomized order. Participants wore a "metabolic armband" (SenseWear Armband Mini) to estimate daily workplace EE (KJ/8 h) while working (1) in a seated work posture (SIT condition) or (2) alternating between a standing and seated work posture every 30 minutes using a sit-stand workstation (STAND-SIT condition). To assess the validity of the metabolic armband, a criterion measure of acute EE (KJ/min; indirect calorimetry) was performed on day 4 of each condition. RESULTS: Standing to work acutely increased EE by 0.7 [95% CI 0.3-1.0] KJ/min (13%), relative to sitting (P = .002). Compared with indirect calorimetry, the metabolic armband provided a valid estimate of EE while standing to work (mean bias: 0.1 [-0.3 to 0.4] KJ/min) but modestly overestimated EE while sitting (P = .005). Daily workplace EE was greatest during the STAND-SIT condition (mean condition difference [95% CI]: 76 [8-144] KJ/8-h workday, P = .03). CONCLUSIONS: Intermittent standing at work can modestly increase daily workplace EE compared with seated work in overweight/obese office workers.

Circuit class or seven-day therapy for increasing intensity of rehabilitation after stroke: protocol of the CIRCIT trial.

RATIONALE: There is strong evidence for a dose-response relationship between physical therapy early after stroke and recovery of function. The optimal method of maximizing physical therapy within finite health care resources is unknown. AIMS: To determine the effectiveness and cost-effectiveness of two alternative models of physical therapy service delivery (seven-days per week therapy services or group circuit class therapy over five-days a week) to usual care for people receiving inpatient rehabilitation after stroke. DESIGN: Multicenter, three-armed randomized controlled trial with blinded assessment of outcomes. STUDY: A total of 282 people admitted to inpatient rehabilitation facilities after stroke with an admission functional independence measure (FIM) score within the moderate range (total 40-80 points or motor 38-62 points) will be randomized to receive one of three interventions: • usual care therapy over five-days a week • standard care therapy over seven-days a week, or • group circuit class therapy over five-days a week. Participants will receive the allocated intervention for the length of their hospital stay. Analysis will be by intention-to-treat. OUTCOMES: The primary outcome measure is walking ability (six-minute walk test) at four-week postintervention with three- and six-month follow-up. Economic analysis will include a costing analysis based on length of hospital stay and staffing/resource costs and a cost-utility analysis (incremental quality of life per incremental cost, relative to usual care). Secondary outcomes include walking speed and independence, ability to perform activities of daily living, arm function, quality of life and participant satisfaction.