Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke: FeSTivaLS trial

Mares, Kathryn, Cross, Jane, Clark, Allan, Vaughan, Susan, Barton, Garry R, Poland, Fiona, Mcglashan, Kate, Watson, Martin, Myint, Phyo K, O’driscoll, Marie-luce and Pomeroy, Valerie M (2014) Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke: FeSTivaLS trial. Trials, 15. ISSN 1745-6215

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Abstract

Background Functional Strength Training (FST) could enhance recovery late after stroke. The aim of this study was to evaluate the feasibility of a subsequent fully powered, randomized controlled trial. Methods The study was designed as a randomized, observer-blind trial. Both interventions were provided for up to one hour a day, four days a week, for six weeks. Evaluation points were before randomization (baseline), after six weeks intervention (outcome), and six weeks thereafter (follow-up). The study took place in participants’ own homes. Participants (n = 52) were a mean of 24.4 months after stroke with a mean age of 68.3 years with 67.3% male. All had difficulty using their paretic upper (UL) and lower limb (LL). Participants were allocated to FST-UL or FST-LL by an independent randomization service. The outcome measures were recruitment rate, attrition rate, practicality of recruitment strategies, occurrence of adverse reactions, acceptability of FST, and estimation of sample size for a subsequent trial. Primary clinical efficacy outcomes were the Action Research Arm Test (ARAT) and the Functional Ambulation Categories (FAC). Analysis was conducted using descriptive statistics and thematic analysis of participants’ views of FST. A power calculation used estimates of clinical efficacy variance to estimate sample size for a subsequent trial. Results The screening process identified 1,127 stroke survivors of whom 52 (4.6%) were recruited. The recruitment rate was higher for referral from community therapists than for systematic identification of people discharged from an acute stroke unit. The attrition rate was 15.5% at the outcome and follow-up time-points. None of the participants experienced an adverse reaction. The participants who remained in the study at outcome had received 68% of the total possible amount of therapy. Participants reported that their experience of FST provided a sense of purpose and involvement and increased their confidence in performing activities. The power calculation provides estimation that 150 participants in each group will be required for a subsequent clinical trial. Conclusions This study found that a subsequent clinical trial was feasible with modifications to the recruitment strategy to be used.

Item Type: Article
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Faculty of Medicine and Health Sciences > Norwich Medical School
Faculty of Medicine and Health Sciences > School of Rehabilitation Sciences
Depositing User: Pure Connector
Date Deposited: 08 Oct 2014 08:50
Last Modified: 22 Aug 2020 23:38
URI: https://ueaeprints.uea.ac.uk/id/eprint/50202
DOI: 10.1186/1745-6215-15-322

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