Remote STrOke Rehabilitation (ReSTORe): study protocol for a randomised controlled trial

Abstract

Abstract Background At least one third of long-term stroke survivors living at home experience ongoing (≥6 months) mild to moderate disability including fatigue, low functional capacity, muscle weakness, anxiety, and depression. Health-related quality of life (HRQoL) and societal participation are affected, particularly after routine contact with health professionals ends. Outpatient centre-based exercise rehabilitation programmes can improve physical and mental health, but these services are rarely provided in the UK. As an alternative, online group physical and mental health rehabilitation is feasible and acceptable to people with long-term conditions and may support recovery for people with stroke. This trial aims to assess the clinical and cost-effectiveness of a supervised, live online, group exercise-based rehabilitation programme (ReSTORe) to support long-term physical and mental health recovery versus best-practice usual care, for people with mild to moderate disability, 6–36 months post-hospital discharge after stroke. Methods ReSTORe is a pragmatic, decentralised, two-arm RCT with internal pilot and embedded economic evaluation and qualitative study. Six hundred adults with long-term mild to moderate physical and/or mental health disability after stroke (exclusions: exercise contra-indicated, severe physical disability, mental health/cognitive impairment, not living at ‘home’) will be randomised (1:08:1) to the ReSTORe intervention or control. The ReSTORe intervention consists of (1) 1:1 individual assessment online; (2) 10-week, once-weekly, remote group exercise programme supervised live online; (3) six online group psychosocial and motivational support sessions. The control intervention is best-practice usual care with a single 30-min 1:1 practitioner appointment and general advice on physical activity. The primary outcome is HRQoL with the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 Preference score (PROPr) at 6 months post-randomisation. Secondary outcomes include PROMIS sub-scores: depression, fatigue, sleep, pain, physical function, social role; health utility; recurrent stroke; and health and social care use. A purposive sample of participants ( n ~ 30–50) and practitioners ( n ~ 8) will be interviewed to explore experiences of the trial, outcomes, and interventions. Discussion ReSTORe is the largest trial to date testing online exercise-based rehabilitation after stroke. The decentralised trial design will support inclusivity and diversity by helping to ensure productive engagement with underrepresented populations. Trial registration ISRCTN ( ISRCTN81848233 ). Registered on 23 January 2025.