A pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of ReTrain (which would assess the clinical and cost effectiveness of ReTrain for stroke survivors).
Background and rationale
Residual physical disability is common following discharge from stroke rehabilitation services. A third of first-time stroke survivors remain physically disabled five years after their stroke, equivalent to more than 300,000 people in the UK. Stroke services are traditionally "front loaded" with provision tailing off a few months after stroke. However, people with stroke report a variety of unmet long-term needs and a sense of being abandoned by NHS services. The UK National Stroke Strategy recommends that stroke be regarded as a Long Term Condition and that continuing support is provided for those who need it. This includes community-based rehabilitation, with an emphasis on personalisation, re-ablement and self-management of the consequences of stroke. There is good evidence that exercise can promote functional recovery, enhance adjustment and coping, improve psychological wellbeing, and reduce the risk of recurrence. Hence stroke guidelines recommend that people with stroke should regularly engage in specific forms of exercise, however many do not meet these recommendations. Various personal and environmental factors may account for this: stroke-related impairments, lack of confidence or knowledge regarding exercise and its benefits, and inadequate provision of support programmes and facilities. In response, community-based programmes are being offered. However, these programmes often focus on fitness rather than function, giving little attention to self-management or to sustaining behaviour (to ensure benefits are maintained after structured programmes have ended). National stroke guidelines recommend interventions address functional improvement and self-management strategies even though a recently updated Cochrane review notes the gap in evidence regarding these interventions.
An approach called ARNI (Action for Rehabilitation from Neurological Injury) attempts to address these concerns; it was created specifically for people with stroke and acquired brain injury who wish to continue their functional recovery.ARNI is not a rigidly-defined programme but a set of principles and strategies tailored to individual circumstances and contexts. It is led by registered exercise professionals who have been additionally trained and accredited by the ARNI institute (http://www.arni.uk.com). In the UK, the NHS, Local Authorities and other organisations are using ARNI trainers to provide community-based training for stroke survivors. Our survey of this training included Northeast England, Lancashire, Luton and Bedfordshire, Milton Keynes, Hillingdon and Cornwall. The survey found that training has been very positively received by stroke survivors, their families and clinicians but it varied in content and delivery. Reports of benefits by the broadcaster Andrew Marr have also increased public awareness of ARNI. However the evidence for ARNI remains largely anecdotal, it may only work for a selected few and the approach is difficult to replicate. There is a need for a more detailed cohesive specification of ARNI that could be rigorously evaluated and replicated. Furthermore a stroke survivor participating in our Institution's research question generation process asked if ARNI worked but as yet there have been no randomised controlled trials (RCTs) of this intervention. Thus we have followed the Medical Research Council's framework for the development and evaluation of complex interventions and undertaken five linked preliminary studies: 1) a survey of current ARNI provision in the UK; 2) a comparison of the ARNI approach with relevant stroke practice guidelines, 3) before-and-after studies of both group-based and 4) one-to-one training and 5) focus groups conducted with our participants. From this work we have designed a programme called ReTrain (Rehabilitation Training) which is based on core ARNI principles and informed by best practice guidelines for stroke. Before undertaking a large definitive RCT of ReTrain a pilot study is needed to address issues of feasibility and acceptability.
Purpose of the study
ReTrain aims to improve (i) functional mobility, (ii) adherence to national guidelines on post-stroke exercise levels, and (iii) health-related quality of life, for people after stroke who have been discharged from clinical rehabilitation. A definitive RCT is required to assess the clinical and cost effectiveness of the ReTrain intervention. The purpose of this pilot study is to assess to feasibility of such a trial and to evaluate trial procedures to inform the design of a definitive trial.
- Rehabilitation Other
Intervention Desc: ReTrain: an exercise-based functional training programme comprising two phases: (1) weekly supervised sessions; (2) monthly drop-in sessions, plus home-based exercise in each phase. Week 1: one-to-one consultations with trainer to introduce programme, assess individual's concerns and capabilities, introduce and negotiate initial goals Weeks 2-11: bi-weekly 90 minute group class with group-based activities and one-to-one coaching, based on ongoing goal negotiation review and progression. Week 12: one-to-one consultations with trainer to review goals and plan ongoing unsupervised exercise programme Weeks 13-24: monthly drop-in sessions for one-to-one consultation, support and progression. ARM 1: Kind: Experimental Label: Rehabilitation training Description: ReTrain: an exercise-based functional training programme comprising two phases: (1) weekly supervised sessions; (2) monthly drop-in sessions, plus home-based exercise in each phase. Week 1: one-to-one consultations with trainer to introduce programme, assess individual's concerns and capabilities, introduce and negotiate initial goals Weeks 2-11: bi-weekly 90 minute group class with group-based activities and one-to-one coaching, based on ongoing goal negotiation review and progression. Week 12: one-to-one consultations with trainer to review goals and plan ongoing unsupervised exercise programme Weeks 13-24: monthly drop-in sessions for one-to-one consultation, support and progression.
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Change in Rivermead Mobility index||Baseline, 6 months, 9 months||No|
|Primary||Change in Timed Up and Go Test||Baseline, 6 months, 9 months||Yes|
|Primary||Change in Modified Patient Specific Functional Scale||Baseline, 6 months, 9 months||Yes|
|Primary||Change in Physical Activity Diary||Baseline, 6 months, 9 months||No|
|Primary||Change in Physical activity - 7-day accelerometry||Baseline, 6 months, 9 months||No|
|Secondary||Fatigue Assessment Scale||Baseline, 6 months, 9 months||No|
|Secondary||Stroke Self-efficacy Questionnaire||Baseline, 9 months||No|
|Secondary||Exercise beliefs questionnaire||Baseline, 9 months||No|
|Secondary||Exercise self-efficacy questionnaire||Baseline, 9 months||No|
|Secondary||Stroke Quality of Life||Baseline, 9 months||No|
|Secondary||EQ-5D-5L||Baseline, 9 months||No|
|Secondary||SF-12 46||Baseline, 9 months||No|
|Secondary||Service Receipt Inventory||Baseline, 9 months||No|
|Secondary||Carer Burden Index||Baseline, 9 months||No|
|Secondary||Adverse incidents||6 months, 9 months||No|