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

Kathryn Mares, Jane Cross, Allan Clark, Susan Vaughan, Garry R Barton, Fiona Poland, Kate McGlashan, Martin Watson, Phyo K Myint, Marie-Luce O'Driscoll, Valerie M Pomeroy

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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.

TRIAL REGISTRATION: Controlled-trials.com ISCTN71632550, 30 January 2009.

Original languageEnglish
Article number322
JournalTrials
Volume15
DOIs
Publication statusPublished - 12 Aug 2014

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Resistance Training
Randomized Controlled Trials
Stroke
Random Allocation
Sample Size
Lower Extremity
Outcome Assessment (Health Care)
Clinical Trials
Health Services Research
Walking
Survivors
Referral and Consultation

Keywords

  • stroke
  • rehabilitation
  • walking
  • upper extremity
  • physical therapy
  • exercise
  • functional strength training

Cite this

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; Pomeroy, Valerie M.

In: Trials, Vol. 15, 322, 12.08.2014.

Research output: Contribution to journalArticle

Mares, K, Cross, J, Clark, A, Vaughan, S, Barton, GR, Poland, F, McGlashan, K, Watson, M, Myint, PK, O'Driscoll, M-L & Pomeroy, VM 2014, 'Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke: FeSTivaLS trial', Trials, vol. 15, 322. https://doi.org/10.1186/1745-6215-15-322
Mares, Kathryn ; Cross, Jane ; Clark, Allan ; Vaughan, Susan ; Barton, Garry R ; Poland, Fiona ; McGlashan, Kate ; Watson, Martin ; Myint, Phyo K ; O'Driscoll, Marie-Luce ; Pomeroy, Valerie M. / Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke : FeSTivaLS trial. In: Trials. 2014 ; Vol. 15.
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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.TRIAL REGISTRATION: Controlled-trials.com ISCTN71632550, 30 January 2009.",
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T1 - Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke

T2 - FeSTivaLS trial

AU - Mares, Kathryn

AU - Cross, Jane

AU - Clark, Allan

AU - Vaughan, Susan

AU - Barton, Garry R

AU - Poland, Fiona

AU - McGlashan, Kate

AU - Watson, Martin

AU - Myint, Phyo K

AU - O'Driscoll, Marie-Luce

AU - Pomeroy, Valerie M

PY - 2014/8/12

Y1 - 2014/8/12

N2 - 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.TRIAL REGISTRATION: Controlled-trials.com ISCTN71632550, 30 January 2009.

AB - 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.TRIAL REGISTRATION: Controlled-trials.com ISCTN71632550, 30 January 2009.

KW - stroke

KW - rehabilitation

KW - walking

KW - upper extremity

KW - physical therapy

KW - exercise

KW - functional strength training

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DO - 10.1186/1745-6215-15-322

M3 - Article

C2 - 25118156

VL - 15

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 322

ER -