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Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial.
Pilot Feasibility Stud. 2018; 4:26.PF

Abstract

BACKGROUND

Impaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed 'Balance Right in MS' (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial.

METHODS/DESIGN

This is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation. The outcomes of this feasibility trial include:Feasibility outcomes, including trial recruitment, retention and completionAssessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)Measures of adherence to the BRiMS programmeData to inform the economic evaluation in a future trialProcess evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience).

DISCUSSION

The BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial.

TRIAL REGISTRATION

ISRCTN13587999.

Authors+Show Affiliations

Faculty of Health and Human Sciences, School of Health Professions, Plymouth University, Peninsula Allied Health Centre, Derriford Rd, Plymouth, PL6 8BH UK.Faculty of Health and Human Sciences, School of Psychology, Portland Square Building, Drake Circus Campus, Plymouth, PL4 8AA UK.School of Health & Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA UK.School of Health & Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA UK. Douglas Grant Rehabilitation Unit, Ayrshire Central Hospital, Kilwinning Road, Irvine, KA12 8SS UK.Peninsula Schools of Medicine and Dentistry, Peninsula Clinical Trials Unit at Plymouth University (PenCTU), Room N16, Plymouth Science Park, Plymouth, PL6 8BX UK. Medical Statistics, Peninsula Schools of Medicine and Dentistry, Room N15, Plymouth Science Park, Plymouth, PL6 8BX UK.University of Exeter Medical School, Health Economics Group, University of Exeter, St Luke's Campus, Exeter, EX1 2 LU UK.Faculty of Health and Human Sciences, School of Health Professions, Plymouth University, Peninsula Allied Health Centre, Derriford Rd, Plymouth, PL6 8BH UK.NIHR Research Design Service (South West), Musgrove Park Hospital, Taunton, TA1 5DA UK.Peninsula Schools of Medicine and Dentistry, Peninsula Clinical Trials Unit at Plymouth University (PenCTU), Room N16, Plymouth Science Park, Plymouth, PL6 8BX UK.Peninsula Schools of Medicine and Dentistry, Peninsula Clinical Trials Unit at Plymouth University (PenCTU), Room N16, Plymouth Science Park, Plymouth, PL6 8BX UK.NIHR Research Design Service, Peninsula Schools of Medicine and Dentistry, ITTC Building, Plymouth Science Park, Plymouth, PL6 8BX UK.Cornwall, UK.School of Medicine, Medical and Biological Sciences, University of St Andrews, North Haugh, St Andrews, KY16 9TF UK.Faculty of Health and Human Sciences, School of Health Professions, Plymouth University, Peninsula Allied Health Centre, Derriford Rd, Plymouth, PL6 8BH UK.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28770099

Citation

Gunn, H, et al. "Balance Right in Multiple Sclerosis (BRiMS): a Guided Self-management Programme to Reduce Falls and Improve Quality of Life, Balance and Mobility in People With Secondary Progressive Multiple Sclerosis: a Protocol for a Feasibility Randomised Controlled Trial." Pilot and Feasibility Studies, vol. 4, 2018, p. 26.
Gunn H, Andrade J, Paul L, et al. Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial. Pilot Feasibility Stud. 2018;4:26.
Gunn, H., Andrade, J., Paul, L., Miller, L., Creanor, S., Green, C., Marsden, J., Ewings, P., Berrow, M., Vickery, J., Barton, A., Marshall, B., Zajicek, J., & Freeman, J. A. (2018). Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial. Pilot and Feasibility Studies, 4, 26. https://doi.org/10.1186/s40814-017-0168-1
Gunn H, et al. Balance Right in Multiple Sclerosis (BRiMS): a Guided Self-management Programme to Reduce Falls and Improve Quality of Life, Balance and Mobility in People With Secondary Progressive Multiple Sclerosis: a Protocol for a Feasibility Randomised Controlled Trial. Pilot Feasibility Stud. 2018;4:26. PubMed PMID: 28770099.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial. AU - Gunn,H, AU - Andrade,J, AU - Paul,L, AU - Miller,L, AU - Creanor,S, AU - Green,C, AU - Marsden,J, AU - Ewings,P, AU - Berrow,M, AU - Vickery,J, AU - Barton,A, AU - Marshall,B, AU - Zajicek,J, AU - Freeman,J A, Y1 - 2017/07/27/ PY - 2017/01/17/received PY - 2017/07/03/accepted PY - 2017/8/4/entrez PY - 2017/8/5/pubmed PY - 2017/8/5/medline KW - Accidental falls KW - Balance KW - Exercise KW - Feasibility randomised controlled trial KW - Mobility KW - Quality of life KW - Secondary progressive multiple sclerosis KW - Self-management SP - 26 EP - 26 JF - Pilot and feasibility studies JO - Pilot Feasibility Stud VL - 4 N2 - BACKGROUND: Impaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed 'Balance Right in MS' (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial. METHODS/DESIGN: This is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation. The outcomes of this feasibility trial include:Feasibility outcomes, including trial recruitment, retention and completionAssessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)Measures of adherence to the BRiMS programmeData to inform the economic evaluation in a future trialProcess evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience). DISCUSSION: The BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial. TRIAL REGISTRATION: ISRCTN13587999. SN - 2055-5784 UR - https://www.unboundmedicine.com/medline/citation/28770099/Balance_Right_in_Multiple_Sclerosis__BRiMS_:_a_guided_self_management_programme_to_reduce_falls_and_improve_quality_of_life_balance_and_mobility_in_people_with_secondary_progressive_multiple_sclerosis:_a_protocol_for_a_feasibility_randomised_controlled_trial_ L2 - https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-017-0168-1 DB - PRIME DP - Unbound Medicine ER -
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