Adults with long-term mild to moderate physical and/or mental health disability after stroke (six to 36 months post-hospital discharge). Circulatory System
Conditions
Interventions
ReSTORe programme: A 10-week rehabilitation intervention including: 1) a 1-hour, 1:1 online assessment
2) supervised, live online, home-based, group exercise sessions
3) live online facilitated group psychosocial and motivational support sessions
4) signposting to a library of ‘on-demand’ exercise sessions
5) a participant workbook.
Control: Best practice usual care: a single online 1:1 appointment with a ReSTORe specialist, including general advice on safe and effective physical activity guided by pub
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 24/03/2026: 1. UK resident 2. Aged =18 3. 6 to 36 months post-hospital discharge after admission for stroke 4. Participant self-report of ongoing post-stroke physical and/or mental health problem 5. Simplified Modified Rankin Scale questionnaire (smRSq) score =4 6. Language and cognitive ability sufficient to follow visual instruction and complete study activities, with support as required. The Consent Support Tool communication screening test will be used to assist as required * 7. Access to, and ability/support to use, a computer or device with internet audio and video 8. Able to understand spoken and written English themselves, or with support from family or friends * As advised by a ReSTORe specialist. Previous key inclusion criteria: 1. UK resident 2. Aged =18 years 3. 6 to 36 months post-hospital discharge after admission for stroke 4. Participant self-report of ongoing post-stroke physical and/or mental health problem 5. Simplified Modified Rankin Scale questionnaire (smRSq) score =4 6. Language and cognitive ability sufficient to follow visual instruction and complete study activities, with support as required. The Consent Support Tool communication screening test will be used to assist as required. 7. Access to, and ability/support to use, a computer or device with internet audio and video. 8. Able to understand spoken and written English themselves, or with support from family or friends
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 24/03/2026: 1. Exercise is contraindicated. This is based on internationally accepted guidelines (American College of Sports Medicine), which identify those who are at considerable risk of exercise-induced complications. There are very few potential participants in whom exercise would be contraindicated, e.g., critical aortic stenosis. * 2. Severe physical disability (smRSq>4) or inability to sit or stand independently with or without aid. Previous work developing exercise interventions for people with stroke highlighted high dropout and session incompletion rates in people who needed support from another individual to stand or sit and transition from one exercise to the next. 3. Mental health or cognitive impairment sufficient to prevent engagement with the study or make participation unsafe. * 4. Living in an institution, e.g. prison, nursing home, or immediate care. + 5. Previous randomisation into the ReSTORe Trial. 6. Another individual from the same household taking part in the ReSTORe trial. * As advised by a ReSTORe specialist. + This exclusion criterion is in place to minimise the risk of cross-contamination between trial arms. If two members of the same household were to be randomised, one allocated to the control group and the other to the ReSTORe intervention, there is a potential risk that the control participant could be inadvertently exposed to elements of the ReSTORe intervention. This could compromise the integrity of the control arm and affect the reliability and validity of the trial outcomes. To prevent this, the WCTU CDMS system will not permit a second individual from the same household to be randomised, and such cases will be excluded. Previous key exclusion criteria: 1. Exercise contra-indicated based on internationally accepted guidelines (American College of Sports Medicine) 2. Severe physical disability (smRSq>4) or inability to sit or stand independently with or without aid 3. Mental health or cognitive impairment sufficient to prevent engagement with the study or make participation unsafe 4. Living in locations other than ‘home’ e.g. prison, nursing home, intermediate care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health-related quality of life (HRQoL) measured using the PROMIS® 29+2 Profile v2.1 (PROPr) at 6 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life (HRQoL) measured using the PROMIS® 29+2 Profile v2.1 (PROPr) at 3 and 12 months post-randomisation. Sub-scores: depression, fatigue, sleep disturbance, pain interference, physical function, social roles/activities and cognitive function. Sub-scales: anxiety and pain intensity. 2. Neurological HRQoL measured using the PROMIS Neuro-QoL short-form v2.0 - Cognitive Function at 3, 6 and 12 months 3. Health utility measured using the EQ-5D-5L at 3, 6 and 12 months 4. Physical Activity measured using the International Physical Activity Questionnaire Short-Form (IPAQ-SF) at 3, 6 and 12 months 5. General health measured by self-reporting of current overall health compared to baseline at 3, 6 and 12 months 6. Health and social care resource use measured using a participant self-report resource use questionnaire at 3, 6 and 12 months 7. Recurrent stroke measured using participant self-report and healthcare data at 3, 6 and 12 months 8. All-cause/cardiovascular mortality measured using healthcare data at 3, 6 and 12 months 9. Adverse events attributable to the trial measured using participant self-report and healthcare data at 3, 6 and 12 months | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactLucy Eggleston
Outcome results
None listed