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, Rhoda Allison, Shirley Stevens, Meriel Norris, Anthony I Shepherd, Raff Calitri, Sarah G Dean, Leon Poltawski, Anne Forster, Rod S Taylor, Anne Spencer, Martin James, 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.

Methods 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.

Trial registration number: NCT02429180; Pre-results.

Keywords: REHABILITATION MEDICINE.

Conflict of interest statement

Conflicts of Interest: None declared.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Figures

Figure 1
Figure 1
Study flow chart.
Figure 2
Figure 2
The ReTrain programme. (ARNI, Action for Rehabilitation from Neurological Injury; GP, general practitioner; TM, trial manager).

References

    1. Feigin VL, Barker-Collo S, McNaughton H et al. . Long-term neuropsychological and functional outcomes in stroke survivors: current evidence and perspectives for new research. Int J Stroke 2008;3:33–40. 10.1111/j.1747-4949.2008.00177.x
    1. Townsend N, Wickramasinghe K, Bhatnagar P et al. . Coronary heart disease statistics: 2012 edition. London: British Heart Foundation, 2012.
    1. Teasell R, Mehta S, Pereira S et al. . Time to rethink long-term rehabilitation management of stroke patients. Top Stroke Rehabil 2012;19:457–62. 10.1310/tsr1906-457
    1. McKevitt C, Fudge N, Redfern J et al. . Self-reported long-term needs after stroke. Stroke 2011;42:1398–403. 10.1161/STROKEAHA.110.598839
    1. Department of Health. National stroke strategy. London: Department of Health, 2007.
    1. Mehta S, Pereira S, Janzen S et al. . Effectiveness of psychological interventions in chronic stage of stroke: a systematic review. Top Stroke Rehabil 2012;19:536–44. 10.1310/tsr1906-536
    1. Hankey GJ, Jamrozik K, Broadhurst RJ et al. . Long-term disability after first-ever stroke and related prognostic factors in the Perth Community Stroke Study, 1989–1990. Stroke 2002;33:1034–40.
    1. Intercollegiate Stroke Working Party. National clinical guideline for stroke. 4th edn London: Royal College of Physicians, 2012.
    1. Poltawski L, Abraham C, Forster A et al. . Synthesising practice guidelines for the development of community-based exercise programmes after stroke. Implement Sci 2013;8:115 10.1186/1748-5908-8-115
    1. Rand D, Eng JJ, Tang PF et al. . How active are people with stroke? Use of accelerometers to assess physical activity. Stroke 2009;40:163–8. 10.1161/STROKEAHA.108.523621
    1. Stroke Association. Stroke statistics. London: Stroke Association, 2013.
    1. Best C, van Wijck F, Dennis J et al. . A survey of community exercise programmes for stroke survivors in Scotland. Health Soc Care Community 2012;20:400–11. 10.1111/j.1365-2524.2011.01043.x
    1. NHS Stroke Improvement Programme. Life after stroke: Participating in community exercise and fitness, (accessed 26 Sept 2016).
    1. Harrington R, Taylor G, Hollinghurst S et al. . A community-based exercise and education scheme for stroke survivors: a randomized controlled trial and economic evaluation. Clin Rehabil 2010;24:3–15. 10.1177/0269215509347437
    1. French B, Thomas LH, Leathley MJ et al. . Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev 2007;(4):CD006073 10.1002/14651858.CD006073.pub2
    1. Lennon S, McKenna S, Jones F. Self-management programmes for people post stroke: a systematic review. Clin Rehabil 2013;27:867–78. 10.1177/0269215513481045
    1. Saunders DH, Sanderson M, Hayes S et al. . Physical fitness training for stroke patients. Cochrane Database Syst Rev 2016;(3):CD003316 10.1002/14651858.CD003316.pub6
    1. Balchin T. The Successful Stroke Survivor: a new guide to functional recovery from stroke. Lingfield, UK: ARNI Trust, 2011.
    1. McCrum R. Andrew Marr, after the stroke: ‘I'm going to be sweeter all round’. London: The Observer, 2013.
    1. Craig P, Dieppe P, Macintyre S et al. . Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008;337:a1655.
    1. Kilbride C, Norris M, Theis N et al. . Action for Rehabilitation from Neurological Injury (ARNI): a pragmatic study of functional training for stroke survivors. Open J Ther Rehabil 2013;1:40–51.
    1. Poltawski L, Briggs J, Forster A et al. . 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. BMC Res Notes 2013;6:324 10.1186/1756-0500-6-324
    1. Norris M, Kilbride C, Mohagheghi A et al. . A qualitative exploration of participation in an exercise instructor led functional training programme for community dwelling stroke survivors. Int J Ther Rehab 2013;20:597–605.
    1. Stroke Association. Exercise and stroke. London: Stroke Association Resources 7, version 1, 2013.
    1. University of Michigan. Geriatric Functional Assessment 2003 volume 2014, 2003. (accessed 27 Sept 2016).
    1. ACSM. American College of Sports Medicine guidelines for exercise testing and prescription. Philadelphia: American College of Sports Medicine, 2005.
    1. Browne RH. On the use of a pilot sample for sample size determination. Stat Med 1995;14:1933–40.
    1. Jorgensen HS, Nakayama H, Raaschou HO et al. . Outcome and time course of recovery in stroke. Part II: time course of recovery. The Copenhagen Stroke Study. Arch Phys Med Rehabil 1995;76:406–12.
    1. Bruno A, Akinwuntan AE, Lin C et al. . Simplified modified rankin scale questionnaire: reproducibility over the telephone and validation with quality of life. Stroke 2011;42:2276–9. 10.1161/STROKEAHA.111.613273
    1. Siemonsma PC, Walker MF. Practical guidelines for independent assessment in randomized controlled trials (RCTs) of rehabilitation. Clin Rehabil 1997;11:273–9.
    1. Simpson LA, Eng JJ, Tawashy AE. Exercise perceptions among people with stroke: barriers and facilitators to participation. Int J Ther Rehab 2011;18:520.
    1. Barker RN, Brauer SG. Upper limb recovery after stroke: the stroke survivors’ perspective. Disabil Rehabil 2005;27:1213–23. 10.1080/09638280500075717
    1. Winward C. Supporting community-based exercise in long-term neurological conditions: experience from the Long-term Individual Fitness Enablement (LIFE) project. Clin Rehabil 2011;25:579–87. 10.1177/0269215510392075
    1. Michie S, Richardson M, Johnston M et al. . The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med 2013;46:81–95. 10.1007/s12160-013-9486-6
    1. Fisher JD, Fisher WA, Williams SS et al. . Empirical tests of an information-motivation-behavioral skills model of AIDS-preventive behavior with gay men and heterosexual university students. Health Psych 1994;13:238–50.
    1. Bartholomew LK. Planning health promotion programs: an intervention mapping approach. San Francisco: Jossey-Bass, 2006.
    1. Green J, Forster A, Young J. A test-retest reliability study of the Barthel Index, the Rivermead Mobility Index, the Nottingham Extended Activities of Daily Living Scale and the Frenchay Activities Index in stroke patients. Disabil Rehabil 2001;23:670–6.
    1. Hsieh CL, Hsueh IP, Mao HF. Validity and responsiveness of the Rivermead mobility index in stroke patients. Scand J Rehabil Med 2000;32:140–2.
    1. Ng SS, Hui-Chan CW. The timed up & go test: its reliability and association with lower-limb impairments and locomotor capacities in people with chronic stroke. Arch Phys Med Rehabil 2005;86:1641–7. 10.1016/j.apmr.2005.01.011
    1. Stratford P, Gill C, Westaway M et al. . Assessing disability and change on individual patients: a report of a patient specific measure. Physiother Can 1995;47:258–63.
    1. Gebruers N, Vanroy C, Truijen S et al. . Monitoring of physical activity after stroke: a systematic review of accelerometry-based measures. Arch Phys Med Rehabil 2010;91:288–97. 10.1016/j.apmr.2009.10.025
    1. Jones F, Partridge C, Reid F. The stroke self-efficacy questionnaire: measuring individual confidence in functional performance after stroke. J Clin Nurs 2008;17:244–52. 10.1111/j.1365-2702.2008.02333.x
    1. Michielsen HJ, De Vries J, Van Heck GL. Psychometric qualities of a brief self-rated fatigue measure: the Fatigue Assessment Scale. J Psychosom Res 2003;54:345–52.
    1. Mead G, Lynch J, Greig C et al. . Evaluation of fatigue scales in stroke patients. Stroke 2007;38:2090–5. 10.1161/STROKEAHA.106.478941
    1. Shaughnessy M, Resnick BM, Macko RF. Reliability and validity testing of the short self-efficacy and outcome expectation for exercise scales in stroke survivors. J Stroke Cerebrovasc Dis 2004;13:214–19. 10.1016/j.jstrokecerebrovasdis.2004.07.002
    1. Bohannon RW, Maljanian R, Lee N et al. . Measurement properties of the short form (SF)-12 applied to patients with stroke. Int J Rehabil Res 2004;27:151–4.
    1. Herdman M, Gudex C, Lloyd A et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x
    1. Williams LS, Weinberger M, Harris LE et al. . Development of a stroke-specific quality of life scale. Stroke 1999;30:1362–9.
    1. University of Leeds. Stroke quality of life questionnaire. University of Leeds, 2011.
    1. Thornton M, Travis SS. Analysis of the reliability of the modified caregiver strain index. J Gerontol B Psychol Sci Soc Sci 2003;58:S127–32.
    1. Craig LE, Wu O, Bernhardt J et al. . Approaches to economic evaluations of stroke rehabilitation. Int J Stroke 2014;9:88–100. 10.1111/ijs.12041
    1. Carnes D, Mullinger B, Underwood M. Defining adverse events in manual therapies: a modified Delphi consensus study. Man Ther 2010;15:2–6. 10.1016/j.math.2009.02.003
    1. European Medicines Agency. Guideline for good clinical practice. London, 2002.
    1. Health Do. Research governance framework for health and social care. 2nd edn London, 2005.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe