A third of stroke survivors remain disabled six months after leaving hospital, with fatigue, weakness, anxiety, and depression that standard care does not adequately address. This UK-wide trial tests whether a 12-week programme of live online group exercise and psychosocial support, delivered to people in their own homes, can improve their quality of life more than a single advice session with a practitioner. The problem is that effective rehabilitation options for long-term stroke disability are scarce. Supervised home-based group rehab works for other chronic conditions, but has never been rigorously tested for stroke survivors with lasting mild to moderate disability. If the ReSTORe programme proves clinically effective and cost-effective, it could offer a low-resource, scalable solution that reaches patients across the UK without requiring travel to clinics. The trial will recruit 600 participants, measure health-related quality of life at six months, and include a full economic analysis to inform NHS commissioning decisions. Success would change national and international practice by giving stroke survivors a practical, evidence-based path back to participation in daily life.
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Background: One third of stroke survivors experience long-term (=6 months) mild to moderate disability including debilitating fatigue, low functional capacity, muscle weakness, anxiety, and depression. Health-related quality of life (HRQoL) and societal participation are affected. There is a need for effective support programmes for this group. Supervised home-based group rehabilitation delivered live online offers a low-resource, clinically effective solution in other long-term conditions, but has not been investigated for people with long-term disability after stroke. Research question: What is the clinical and cost-effectiveness of supervised, live online, home-based, group rehabilitation for people with long-term mild to moderate disability after stroke? Design/setting: 6-month internal pilot (n~200) to confirm recruitment prior to a UK-wide, decentralised, 2-arm RCT with 1:1.08 treatment allocation randomised by minimisation based on sex, age and modified Rankin Scale score. Population: Adults with mild to moderate physical and/or mental health disability 6–36 months post-hospital discharge after stroke. Exclusion: physical/mental health or cognitive impairment sufficient to prevent engagement or make participation unsafe. Health technology: The 12-week ‘Remote STrOke Rehabilitation’ (ReSTORe) intervention, includes: 1) 1:1 online assessment; 2) live online supervised, group, home-based exercise sessions; 3) live online psychosocial/motivational support sessions; 4) library of ‘on-demand’ exercise sessions; 5) participant workbook. Control: Best-practice usual care: 1:1 online practitioner appointment with general advice on physical activity. Outcomes. Measured online at baseline, 3, 6, and 12 months. Primary–HRQoL: PROMIS-PROPr score at 6 months. Secondary: PROMIS 29+2 fatigue, cognitive function, anxiety/depression, pain, physical function, sleep, social roles/activities sub-scores/scales; physical activity, health utility, health/social care use, mortality, adverse events. Sample size: Allowing for 20% loss to follow-up, 600 participants (288 control, 312 intervention) are required to achieve 90% power at 5% significance level; based on a between groups difference of 0.04 on the PROPr score, SD of 0.18, a correlation between baseline and primary outcome timepoints of 0.7, and intervention group cluster size of 8. Analysis. Reported as per CONSORT with intention-to-treat analyses. A partially nested heteroscedastic regression model will estimate the intervention effect (with 95% CIs), adjusted for clinically important variables. Pre-specified, exploratory sub-group analyses will examine the interactions with treatment assignment. Cost-effectiveness will be assessed as incremental cost per QALY estimates and credible intervals, cost-effectiveness acceptability curve and value-of-information analyses. Team: Patient partners, clinical exercise physiology, stroke rehabilitation, health psychology, speech and language therapy, stroke medicine, general practice, statistics, health economics, clinical trialists. Timeline(months): ethics, set-up, pre-pilot (-3 to 3); internal pilot (4 to 9); recruitment (4 to 18); primary outcome (10 to 24), 12-month follow-up (16 to 30), analysis, dissemination, reporting (31 to 33). Impact/dissemination: ReSTORe could change practice nationally and globally. Collaboration with patient partners, charities, governing bodies and guideline committees will ensure timely, accessible dissemination.
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