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 studyReport as inadecuate




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BMC Research Notes

, 6:324

First Online: 13 August 2013Received: 21 November 2012Accepted: 12 August 2013DOI: 10.1186-1756-0500-6-324

Cite this article as: Poltawski, L., Briggs, J., Forster, A. et al. BMC Res Notes 2013 6: 324. doi:10.1186-1756-0500-6-324

Abstract

BackgroundTo inform the design of a randomised controlled trial RCT of an exercise-based programme for long term stroke survivors, we conducted a mixed methods before-and-after case series with assessment at three time points. We evaluated Action for Rehabilitation from Neurological Injury ARNI, a personalised, functionally-focussed programme. It was delivered through 24 hours of one-to-one training by an Exercise Professional EP, plus at least 2 hours weekly unsupervised exercise, over 12- 14 weeks. Assessment was by patient-rated questionnaires addressing function, physical activity, confidence, fatigue and health-related quality of life; objective assessment of gait quality and speed; qualitative individual interviews conducted with participants. Data were collected at baseline, 3 months and 6 months. Fidelity and acceptability was assessed by participant interviews, audit of participant and EP records, and observation of training.

FindingsFour of six enrolled participants completed the exercise programme. Quantitative data demonstrated little change across the sample, but marked changes on some measures for some individuals. Qualitative interviews suggested that small benefits in physical outcomes could be of great psychological significance to participants. Participant-reported fatigue levels commonly increased, and non-completers said they found the programme too demanding. Most key components of the intervention were delivered, but there were several potentially important departures from intervention fidelity.

DiscussionThe study provided data and experience that are helping to inform the design of an RCT of this intervention. It suggested the need for a broader recruitment strategy; indicated areas that could be explored in more depth in the qualitative component of the trial; and highlighted issues that should be addressed to enhance and evaluate fidelity, particularly in the preparation and monitoring of intervention providers. The experience illustrates the value of even small sample before-and-after studies in the development of trials of complex interventions.

KeywordsStroke Exercise Feasibility study Complex interventions AbbreviationsARNIAction for rehabilitation from neurological injury

CSCase

EPExercise professional

mRSModified rankin score

FASFatigue assessment scale

NEADLNottingham extended activities of daily living

MCIDMinimum clinically important difference

MSDMinimum significant difference

POMAPerformance oriented mobility assessment

RCTRandomised controlled trial

RNLIReintegration into normal living index

TUGTimed up and go.

Electronic supplementary materialThe online version of this article doi:10.1186-1756-0500-6-324 contains supplementary material, which is available to authorized users.

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Author: Leon Poltawski - Jacqueline Briggs - Anne Forster - Victoria A Goodwin - Martin James - Rod S Taylor - Sarah Dean

Source: https://link.springer.com/



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