Study Results
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Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2015-07-31
2016-01-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rehabilitation training
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.
Rehabilitation
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.
Control
Control: treatment as usual plus receipt of a UK Stroke Association booklet on exercise after stroke.
No interventions assigned to this group
Interventions
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Rehabilitation
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.
Eligibility Criteria
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Inclusion Criteria
* \>1 month (but no upper limit) since discharge from NHS physical rehabilitation services at randomisation
* Able to walk independently indoors with or without mobility aids, but has self-reported difficulty or requires help on stairs, slopes or uneven surfaces (assessed by recruiting team using standard tools)
* Willingness to be randomised to either control or ReTrain (and attend the training venue)
* Cognitive capacity and communication ability sufficient to participate in the study (assessed by recruiting team using standard tools).24 NB: Criterion (3) has been selected pragmatically to maximise eligibility while ensuring participants have a mobility deficit that could be addressed by the intervention. Eligible people with aphasia will not be excluded.
Exclusion Criteria
* Contraindications to moderate to vigorous physical activity. Used in GP screening assessment form. (Adapted from ACSM guidelines 25) Contraindications include:
* Acute or uncontrolled heart failure
* Unstable or uncontrolled angina
* Uncontrolled cardiac dysrhythmia causing symptoms or haemodynamic compromise
* Symptomatic severe aortic stenosis
* Current deep vein thrombosis, pulmonary embolus or pulmonary infarction
* Acute myocarditis or pericarditis
* Suspected or known dissecting aneurysm
* Unstable / uncontrolled blood pressure
* Systolic blood pressure \> 160
* Diastolic blood pressure \> 100
* Acute systemic infection
* Uncontrolled diabetes
18 Years
ALL
No
Sponsors
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The Stroke Association, United Kingdom
OTHER
University of Exeter
OTHER
Responsible Party
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Principal Investigators
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Sarah Dean, PhD
Role: STUDY_CHAIR
University of Exeter Medical School
Rod Taylor, Prof
Role: STUDY_DIRECTOR
University of Exeter Medical School
Anne Forster, Prof
Role: STUDY_DIRECTOR
University of Leeds
Anne Spencer, Prof
Role: STUDY_DIRECTOR
University of Exeter Medical School
Martin James, Dr
Role: STUDY_DIRECTOR
Royal Devon and Exeter NHS Foundation Trust
Rhoda Allison, Dr
Role: STUDY_DIRECTOR
Torbay & Southern Devon Health & Care Trust
Shirley Stevens, Mrs
Role: STUDY_DIRECTOR
PenPIG
Meriel Norris, Dr
Role: STUDY_DIRECTOR
Brunel University
Leon Poltawski, Dr
Role: STUDY_DIRECTOR
University of Exeter Medical School
Locations
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University of Exeter Medical School
Exeter, Devon, United Kingdom
Countries
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References
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Hollands L, Calitri R, Warmoth K, Shepherd A, Allison R, Dean S; ReTrain Trial; team. Assessing the fidelity of the independently getting up off the floor (IGO) technique as part of the ReTrain pilot feasibility randomised controlled trial for stroke survivors. Disabil Rehabil. 2022 Dec;44(25):7829-7838. doi: 10.1080/09638288.2021.1998672. Epub 2021 Nov 12.
Norris M, Poltawski L, Calitri R, Shepherd AI, Dean SG; ReTrain Team. Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial. Trials. 2019 Aug 23;20(1):525. doi: 10.1186/s13063-019-3633-8.
Norris M, Poltawski L, Calitri R, Shepherd AI, Dean SG; ReTrain Team. Acceptability and experience of a functional training programme (ReTrain) in community-dwelling stroke survivors in South West England: a qualitative study. BMJ Open. 2018 Jul 25;8(7):e022175. doi: 10.1136/bmjopen-2018-022175.
Dean SG, Poltawski L, Forster A, Taylor RS, Spencer A, James M, Allison R, Stevens S, Norris M, Shepherd AI, Landa P, Pulsford RM, Hollands L, Calitri R. Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility. BMJ Open. 2018 Feb 15;8(2):e018409. doi: 10.1136/bmjopen-2017-018409.
Dean SG, Poltawski L, Forster A, Taylor RS, Spencer A, James M, Allison R, Stevens S, Norris M, Shepherd AI, Calitri R. Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain). BMJ Open. 2016 Oct 3;6(10):e012375. doi: 10.1136/bmjopen-2016-012375.
Related Links
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Action for rehabilitation after neurological injury
PenCLAHRC
Other Identifiers
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CRF192
Identifier Type: -
Identifier Source: org_study_id
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