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Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme

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Balance Right in Multiple Sclerosis (BRiMS) : a feasibility randomised controlled trial of a falls prevention programme. / Gunn, H.; Stevens, K. N.; Creanor, S.; Andrade, J.; Paul, L.; Miller, L.; Green, C.; Ewings, P.; Barton, A.; Berrow, M.; Vickery, J.; Marshall, B.; Zajicek, J.; Freeman, J. A.

In: Pilot and Feasibility Studies, Vol. 7, No. 1, 2, 04.01.2021.

Research output: Contribution to journalArticlepeer-review

Harvard

Gunn, H, Stevens, KN, Creanor, S, Andrade, J, Paul, L, Miller, L, Green, C, Ewings, P, Barton, A, Berrow, M, Vickery, J, Marshall, B, Zajicek, J & Freeman, JA 2021, 'Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme', Pilot and Feasibility Studies, vol. 7, no. 1, 2. https://doi.org/10.1186/s40814-020-00732-9

APA

Gunn, H., Stevens, K. N., Creanor, S., Andrade, J., Paul, L., Miller, L., Green, C., Ewings, P., Barton, A., Berrow, M., Vickery, J., Marshall, B., Zajicek, J., & Freeman, J. A. (2021). Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme. Pilot and Feasibility Studies, 7(1), [2]. https://doi.org/10.1186/s40814-020-00732-9

Vancouver

Gunn H, Stevens KN, Creanor S, Andrade J, Paul L, Miller L et al. Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme. Pilot and Feasibility Studies. 2021 Jan 4;7(1). 2. https://doi.org/10.1186/s40814-020-00732-9

Author

Gunn, H. ; Stevens, K. N. ; Creanor, S. ; Andrade, J. ; Paul, L. ; Miller, L. ; Green, C. ; Ewings, P. ; Barton, A. ; Berrow, M. ; Vickery, J. ; Marshall, B. ; Zajicek, J. ; Freeman, J. A. / Balance Right in Multiple Sclerosis (BRiMS) : a feasibility randomised controlled trial of a falls prevention programme. In: Pilot and Feasibility Studies. 2021 ; Vol. 7, No. 1.

Bibtex - Download

@article{7bfdc66592f4429abfb18694869fc53f,
title = "Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme",
abstract = "BackgroundBalance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The “Balance Right in MS (BRiMS)” intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial.MethodsThis randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone.Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries.ResultsFifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were > 98% for all outcomes apart from the falls diary (return rate 62%).After adjusting for baseline score, mean intervention—usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: − 7.7 (95% confidence interval [CI] − 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI − 7.8 to 9), psychological − 0.4 (CI − 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23).ConclusionsProcedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible.Trial registration ISRCTN13587999 ",
keywords = "Secondary progressive multiple sclerosis, Exercise, Self-management, Mobility, Accidental falls, Balance, Quality of life, Feasibility randomised controlled trial",
author = "H. Gunn and Stevens, {K. N.} and S. Creanor and J. Andrade and L. Paul and L. Miller and C. Green and P. Ewings and A. Barton and M. Berrow and J. Vickery and B. Marshall and J. Zajicek and Freeman, {J. A.}",
note = "This study was funded by the NIHR Health Technology Assessment Programme (14/176/12), United Kingdom. ",
year = "2021",
month = jan,
day = "4",
doi = "10.1186/s40814-020-00732-9",
language = "English",
volume = "7",
journal = "Pilot and Feasibility Studies",
issn = "2055-5784",
publisher = "BioMed Central",
number = "1",

}

RIS (suitable for import to EndNote) - Download

TY - JOUR

T1 - Balance Right in Multiple Sclerosis (BRiMS)

T2 - a feasibility randomised controlled trial of a falls prevention programme

AU - Gunn, H.

AU - Stevens, K. N.

AU - Creanor, S.

AU - Andrade, J.

AU - Paul, L.

AU - Miller, L.

AU - Green, C.

AU - Ewings, P.

AU - Barton, A.

AU - Berrow, M.

AU - Vickery, J.

AU - Marshall, B.

AU - Zajicek, J.

AU - Freeman, J. A.

N1 - This study was funded by the NIHR Health Technology Assessment Programme (14/176/12), United Kingdom.

PY - 2021/1/4

Y1 - 2021/1/4

N2 - BackgroundBalance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The “Balance Right in MS (BRiMS)” intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial.MethodsThis randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone.Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries.ResultsFifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were > 98% for all outcomes apart from the falls diary (return rate 62%).After adjusting for baseline score, mean intervention—usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: − 7.7 (95% confidence interval [CI] − 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI − 7.8 to 9), psychological − 0.4 (CI − 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23).ConclusionsProcedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible.Trial registration ISRCTN13587999

AB - BackgroundBalance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The “Balance Right in MS (BRiMS)” intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial.MethodsThis randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone.Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries.ResultsFifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were > 98% for all outcomes apart from the falls diary (return rate 62%).After adjusting for baseline score, mean intervention—usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: − 7.7 (95% confidence interval [CI] − 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI − 7.8 to 9), psychological − 0.4 (CI − 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23).ConclusionsProcedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible.Trial registration ISRCTN13587999

KW - Secondary progressive multiple sclerosis

KW - Exercise

KW - Self-management

KW - Mobility

KW - Accidental falls

KW - Balance

KW - Quality of life

KW - Feasibility randomised controlled trial

U2 - 10.1186/s40814-020-00732-9

DO - 10.1186/s40814-020-00732-9

M3 - Article

VL - 7

JO - Pilot and Feasibility Studies

JF - Pilot and Feasibility Studies

SN - 2055-5784

IS - 1

M1 - 2

ER -

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