Clinical Research into ARNI Approach

Research concerning the ARNI approach 2010-2016

 

1. Stroke Research Network  stroke research network

Statement from Jacqueline Briggs (South West Stroke Research Network Manager) and Dr Sarah Dean (Peninsula College of Medicine) (January 2011):

‘The Peninsula Collaboration for Leadership in Applied Health Research and Care (PenCLAHRC) and the South West Stroke Research Network, have developed a research funding proposal to evaluate the effect of the ARNI rehabilitation strategies.

ReTrain

: evaluating the effectiveness and cost-effectiveness of a physical REhabilitation TRAINing programme for people six to twelve months post acute stroke.

stroke training therapyThis research will compare the clinical effectiveness and cost-effectiveness of a physical rehabilitation intervention (in addition to usual care) with treatment as usual, for people six to 12 months on from stroke. Action for Rehabilitation from Neurological Injury (ARNI) is a manual-based, exercise programme designed for use at least six months after stroke when very few stroke survivors will be receiving further rehabilitative therapy.

The programme addresses activity restriction in daily life through exercise tasks that are based on functional activities, strength and cardiovascular fitness training and could be plausibly delivered across the UK. We are working with our colleagues in other research and clinical Networks across the region and nationally so that if the project is funded we can study the technique over a large number of people in different regions.

The clinical effectiveness and cost effectiveness of ARNI was the focus of an application for a national multi-centre RCT (£1.79 million) by PenCLAHRC in June 2010 and the research team ran a clinical trial development research programme in 2011 culminating in a research grant bid in July 2012.

A full-time research fellow, Leon Poltawski, has been employed on ReTrain.

Sarah Dean, Senior Lecturer in Health Services Research, Peninsula Medical School, explains what the ReTrain Project is and how it became a PenCLAHRC project through the influence of patient involvement. Press here to get a copy of the PenCLAHRC Post-Issue 4.

LIVE PROJECT: Press here to view the latest on Retrain Project.

stroke exercise research projectAnticipated impacts of the development phase of the project

  • We will publish case studies about of the experiences of stroke survivors participating in the ARNI programme and of instructors delivering it, in order to describe the value of the programme
  • We will publish a ‘map’ of the ARNI intervention manual, detailing ways in which survivors’ lifestyles can be improved.
  • Work with professionals and collaborators will allow us to identify the cost and complexity of implanting ARNI into the NHS: determining whether this is acceptable and feasible.

Project News: July 2012: a funding application for ReTrain has been submitted.

The PenCLAHRC team have now joined up with collaborators from the University of Brunel and together with Anne Forster from the University of Leeds a joint application for funding a full clinical trial has been submitted to the NIHR funding programme called Efficacy, Mechanism and Evaluation (EME). The team should hear this Autumn if the application has been short listed.

The case series has been presented as a poster at the Society of Research in Rehabilitation meeting, Leeds, July 2012 @ results to be presented at Harrogate Stroke Conference and shortly to be published.

Paper published 13th August 2013 in British Medical Council Research Notes:

Informing the design of a randomised controlled trial of an exercise-based programme for long term stroke survivors: lessons from a before-and-after case series study: Leon Poltawski, Jacqueline Briggs, Anne Forster, Victoria A Goodwin, Martin James, Rod S Taylor and Sarah Dean.

Qualitative interviews: All completers were interviewed at all time points. Of the non-completers, one consented to a post-programme interview but the other preferred only a brief telephone discussion. Follow-up interviews were not conducted in either case. A number of themes relating to outcomes were identified in the analysis of interviews:

1. Individual physical benefits. All completers reported a range of physical improvements. These included increased upper limb and core strength, greater range and control of upper limb movement, better balance and overall fitness. Improvements in functional capacities and activities included ability to transfer, being able to turn over in bed, better walking quality, and easier lifting and manipulation of kitchen equipment.

2. Small changes and their personal significance. Benefits that might have been missed or seen as minor by others, were reported as personally important by the individual. For instance, one person was delighted to be able to move his fingers on a previously inert hand, even though this did not produce any functional improvement. Another felt more in control and comfortable after gaining sufficient core strength to stay upright in a cornering vehicle. The significance of such benefits appeared to rest on their psychological value to the individual, which was apparent in several dimensions, described below.

3. Awakening to personal potential. All participants were long term stroke survivors who had been discharged from clinical rehabilitation with the message that little further improvement was likely. Participation in the programme convinced the completers, sometimes to their surprise, that they were capable of further progress. This was said to engender hope, help build self-esteem, self-belief and a sense of continuing on an improving trajectory. However, confidence may have been undermined for those who did not complete the programme. One spoke of frustration and disappointment on not being able to cope with its demands.

4. Self-management and support. Completion of the programme was reported to enhance self-management capacity by increasing the personal repertoire of exercises and activities, and knowledge of training principles and their application after stroke. However, intentions to self-develop exercise programmes that were expressed just after the programme were often not carried through by follow-up interview: there was an admission that motivation was hard to sustain once supervision had ended, and one completer reported working hard within sessions but doing virtually no exercise outside them.

Several issues relating to programme delivery were also identified in the analysis:

(i) The high demand, intensive approach was seen as key to becoming aware of personal potential by those who completed the programme. However it was also a source of fatigue, and was cited as a reason for leaving the programme by those who withdrew.

(ii) Whilst health professionals were often felt to be risk-averse and having low expectations of their patients, the high expectation, can-do attitude of the EPs was valued and cited as a strong motivational factor by the completers. Conversely, it was seen as sometimes unrealistic by the non-completers.

(iii)  For several participants, being treated as a client to be coached and trained, rather than a patient to be made well, helped create a sense of normalisation which contributed to self-confidence and self-image. The primary reason given by the two participants who did not complete the programme was an inability to cope with its demands. Both felt that the EP had unreasonable expectations of what they could achieve, and CS1 complained of substantial post-exercise soreness. Other factors may also have been involved. CS1 had a range of co-morbidities and CS4 identified increasing levels of fatigue that preceded enrolment in the study. Neither reported exercising regularly before the programme, and – in contrast to the completers – neither lived with a partner who supported their involvement in the programme.

Paper published 3rd October 2016 in British Medical Journal:  Volume 6, Issue 10

BMJ Open 6:e012375 doi:10.1136/bmjopen-2016-012375
  • Rehabilitation medicine

Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain) Sarah G Dean, Leon Poltawski, Anne Forster, Rod S Taylor, Anne Spencer, Martin James,3, Rhoda Allison, Shirley Stevens, Meriel Norris, Anthony I Shepherd, Raff Calitri

Abstract

Introduction The Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.

f1-largeMethods and analysis A 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9 months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.

Ethics and dissemination National Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised Trainer and Intervention Delivery manuals for multicentre replication of ReTrain; presentations at conferences, public involvement events; internationally recognised peer-reviewed journal publications, open access sources and media releases.

2. The Independently Getting up Off the floor (IGO) Study

stroke research study

ongoing stroke research

A group of researchers from PenCLAHRC and the Peninsula College of Medicine & Dentistry, in collaboration with University of Exeter, South West Stroke Research Network and local stroke services, have successfully obtained funding from the small grants scheme at the Royal Devon and Exeter Hospital to undertake the IGO study.

Background:
Falls are common among stroke survivors, and fear of falls or the inability to get up from the floor may discourage individuals from participating in everyday life – for instance by leaving the house or playing with children on the floor. Many stroke survivors are not taught how to rise from the floor, or think they do not have the ability to do so because of one-sided weakness. Some are able to rise by “furniture climbing” but could not do so outside, where there may be no nearby supports. Learning a technique to independently get up without aids may enhance confidence, encourage participation, and reduce calls on emergency services.

IGO has been designed to:
• Assess the safety and potential efficacy of a technique to enable a stroke survivor with hemiplegia to transfer from floor to standing without supports or assistance.
• Assess the feasibility and acceptability of teaching and learning the technique.
• Identify potential secondary benefits of learning the technique.

Jan 2013: IGO Research Ongoing

3. Brunel University Feasibility Study stroke exercise study

national stroke conferenceA 48-week feasibility study started in August 2010, with 4 groups of 8 stroke survivors, performed in collaboration with Hillingdon Hospital. Dr Cherry Kilbride (Chair of ACPIN) and colleagues from Brunel University are carrying out the research.

Study Participants reported: improved mobility, range of movement, action control, strength, confidence and reduced fear of the consequences of exercise.

Jan 2013 update: Brunel University Results presented at National UKSF Stroke Conference December 2012 – READ PUBLISHED DEC 2013 PAPER HERE (International Journal of Therapy and Rehabilitation, December 2013, Vol 20, No 12)

4. MILTON KEYNES REPORT – 2014 – a sample of small scale local report

Different Strokes Milton Keynes Group, in partnership with Shenley Leisure Centre, Central and North West London NHS Foundation Trust, and Action for Rehabilitation from Neurological Injury (ARNI) set up a series of pilot group sessions for stroke survivors using the ARNI approach. Six participants, volunteers from the Different Strokes Group, took part in the sessions which took place weekly for six weeks. Monthly follow up sessions have alsobeen arranged for November and December 2013 to give participants an opportunity to refresh their programmes, report on progress and boost their motivation. The main aims for the pilot from the ARNI perspective were that participants would: have information about suitable ARNI techniques for their individual situation; establish, or add to existing independent training outside the sessions using ARNI techniques; and have the tools and motivation to continue with their training after the pilot sessions ceased.

stroke health services

Participants ranged in age from 52 to 72, two are in their 50s, two in their 60s and two in their 70s. Time since stroke was from 2 to 10 years and levels of mobility varied widely from ability to walk independently, to use of wheelchair and hoist. Movement and control in affected arm and hand ranged from gross arm movement with little or no discernible hand movement to virtually full function of arm and hand.

Each week, the participants were given a tailored programme of exercises, designed around their own goals with encouragement to aim for daily practice with one or two rest days per week. All six participants completed the programme and only one missed a session because of a prior commitment.

Blood pressure did not appear to be adversely affected by the exercise class. Some individuals showed a small decrease in blood pressure. Ambulant participants all decreased their time on Timed Up and Go, and one participant who was unable to walk without the stick at all at the beginning of the trial completed the task without a stick at the end of the sessions. Berg Balance Tests for three of the four were improved. The majority noticed small improvements in their upper limb function. 3 of the 4 ambulant participants said their level of mobility had improved in some way. Participants also mentioned being able to return to activities, such as dancing, which they had not done since before their stroke.

Five out of six participants have become more independent or effective in daily activities such as preparing food, eating, getting dressed, or mobility. These participants did home training between sessions, some of them a substantial amount. All of the 4 who are ambulant practiced getting down to the floor and up again from standing in the group sessions, some for the first time. All participants had experimented with attempting new things and tasks they thought they could not do. Five out of six participants said they felt they had made progress towards the goals they set at the beginning of the programme. Confidence increased for the majority of participants both in doing particular tasks, such as walking, and more generally in social situations.

All felt the programme could have been longer than 6 weeks although most said that the time had been effective in getting them started on the ARNI techniques and that they were looking forward to the monthly follow up sessions. All made positive comments about the programme and were keen for ARNI in Milton Keynes to be expanded to provide longer programmes, and that ARNI techniques be made available to a wider audience.

It is recommended that ARNI Instruction be provided in group sessions in Milton Keynes, through the AMKERS referral scheme and that existing AMKERS personal trainers be trained to Qualified Instructor status in the ARNI techniques.

download full report HERE