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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.

ABSTRACT: 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.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).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.ISRCTN13587999.

SUBMITTER: Gunn H

PROVIDER: S-EPMC5530568 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Project description: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 registrationISRCTN13587999 Date of registration: 29 September 2016.

Project description:IntroductionIndividuals with minimal disability from multiple sclerosis (MS) requested advice on finding the right balance, between too much and too little exercise, when participating in their choice of sport or exercise. To optimise exercise participation during the early stages of the disease, a flexible exercise participation programme (FEPP) has been developed. The FEPP is novel because it provides guidance and support for individuals with MS to participate and progress in their preferred sport or exercise. The primary objective was to assess the feasibility of the FEPP. The secondary objective was to assess the feasibility of a larger trial to demonstrate the efficacy of the FEPP.Methods and analysisA stage I feasibility study of the FEPP, using a single group preintervention/post-intervention design, will be conducted with 16 participants with minimal disability from MS (Expanded Disability Status Scale level of 0-3.5). The 12-week FEPP will guide participants to independently participate in their preferred sport or exercise at a location of their choice. Exercise progression will be guided by individual energy levels and a weekly telephone coaching session with a physiotherapist. Participation in exercise or sport will be recorded in parallel with assessment of disease biomarkers (plasma cytokines interleukin (IL)-2, IL-4, IL-6, IL-10, interferon (IFN)-γ and tumour necrosis factor (TNF)), subjective vitality and high-level mobility. Acceptability of the FEPP will be assessed using a sequential explanatory mixed methods design where the findings of a participant survey will inform the interview guide for a series of focus groups.Feasibility of a larger trial will be assessed via process, resources, management and scientific metrics. Progression to a larger trial will depend on the achievement of specified minimum success criteria.Ethics and disseminationEthical approval has been obtained for this study from the James Cook University Human Research Ethics Committee (H7956). Dissemination of findings is planned via peer-reviewed journals, conference presentations and media releases. The protocol date was 21 December 2019, V.1.Trial registration numberThe trial is registered with Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000076976.

Project description:Background:Disability accumulation in progressive multiple sclerosis (MS) results from inflammatory and neurodegenerative mechanisms. In animal models of MS, lithium acts to reduce inflammatory demyelination, and in models of neurodegenerative diseases, lithium also slows neuronal death. Prospective studies of lithium in MS patients have not been previously undertaken. Objective:To determine the tolerance and feasibility of using low-dose (150-300 mg/daily) lithium as a pharmaceutical intervention in a cohort of subjects with progressive MS, and to gauge preliminary effects of lithium on change in brain volume over time. Methods:Patients with primary or secondary progressive MS were recruited into a 2-year, single-blind crossover trial in which subjects were randomly assigned to take lithium in year 1 or 2. The primary outcomes of interest were tolerance of lithium and percentage brain volume change (PBVC) on vs. off lithium. Secondary outcomes included relapse rates, disability changes, and self-report scales assessing fatigue, mood, and quality of life (QOL). Results:Of 24 screened patients, 23 were randomized to take lithium during year 1 (n = 11) or 2 (n = 12). Two subjects discontinued the trial due to lithium side effects. Other reasons for discontinuation included personal reasons (n = 2), worsening MS (n = 1), and development of multiple myeloma (n = 1). For the 17 who completed the trial, change in PBVC on lithium (+0.107) did not significantly differ from the observation period (-0.355, p = 0.346). Disability measured by Expanded Disability Status Scale and MS Functional Composite did not differ by lithium treatment status. On patient reported measures of mental well-being, subjects reported fewer depressive symptoms on the Beck Depression Inventory (12.3 vs. 15.8, p = 0.016) and more favorably on the mental domains of the MSQOL inventory (56.7 vs. 52.4, p = 0.028). Conclusions:Low-dose lithium is well tolerated in persons with MS. Taking lithium did not result in differences in PBVC, relapses, or disability, but conclusions were limited by study design and sample size. Despite concern for lithium-associated neurological side effects, subjects taking lithium did not report worsened fatigue or physical well-being. On measures of mood and mental health QOL, subjects scored more favorably while taking lithium. Clinicaltrialsgov identifier:NCT01259388.

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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.

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