Clinical trial NCT02429180: Rehabilitation Training After Stroke
Official title: Community-based Rehabilitation Training After Stroke: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: The Stroke Association, United Kingdom
First posted: 2015-04-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Primary clinical diagnosis of stroke (assessed by referring clinician/GP records)
* \>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:

* \<18 years old
* 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

Primary outcomes:
measure: Change in Rivermead Mobility index
timeFrame: Baseline, 6 months, 9 months
measure: Change in Timed Up and Go Test
timeFrame: Baseline, 6 months, 9 months
measure: Change in Modified Patient Specific Functional Scale
timeFrame: Baseline, 6 months, 9 months
measure: Change in Physical Activity Diary
timeFrame: Baseline, 6 months, 9 months
measure: Change in Physical activity - 7-day accelerometry
timeFrame: Baseline, 6 months, 9 months
Secondary outcomes:
measure: Fatigue Assessment Scale
timeFrame: Baseline, 6 months, 9 months
measure: Stroke Self-efficacy Questionnaire
timeFrame: Baseline, 9 months
measure: Exercise beliefs questionnaire
timeFrame: Baseline, 9 months
measure: Exercise self-efficacy questionnaire
timeFrame: Baseline, 9 months
measure: Stroke Quality of Life
timeFrame: Baseline, 9 months
measure: EQ-5D-5L
timeFrame: Baseline, 9 months
measure: SF-12 46
timeFrame: Baseline, 9 months
measure: Service Receipt Inventory
timeFrame: Baseline, 9 months
measure: Carer Burden Index
timeFrame: Baseline, 9 months
measure: Adverse incidents
timeFrame: 6 months, 9 months
Other outcomes:
measure: The type and frequency of health and allied services measured using an adapted Client Service Receipt Inventory based on the TRACS study
timeFrame: 0-9 months
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter Medical School
state: Devon
Study officials:
affiliation: University of Exeter Medical School
name: Sarah Dean, PhD
role: STUDY_CHAIR
affiliation: University of Exeter Medical School
name: Rod Taylor, Prof
role: STUDY_DIRECTOR
affiliation: University of Leeds
name: Anne Forster, Prof
role: STUDY_DIRECTOR
affiliation: University of Exeter Medical School
name: Anne Spencer, Prof
role: STUDY_DIRECTOR
affiliation: Royal Devon and Exeter NHS Foundation Trust
name: Martin James, Dr
role: STUDY_DIRECTOR
affiliation: Torbay & Southern Devon Health & Care Trust
name: Rhoda Allison, Dr
role: STUDY_DIRECTOR
affiliation: PenPIG
name: Shirley Stevens, Mrs
role: STUDY_DIRECTOR
affiliation: Brunel University
name: Meriel Norris, Dr
role: STUDY_DIRECTOR
affiliation: University of Exeter Medical School
name: Leon Poltawski, Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.