A self-management programme to reduce falls and improve safe mobility in people with secondary progressive MS: the BRiMS feasibility RCT

Abstract

Background Balance, mobility impairments and falls are common problems for people with multiple sclerosis (MS). Our ongoing research has led to the development of Balance Right in MS (BRiMS), a 13-week home- and group-based exercise and education programme intended to improve balance and encourage safer mobility. Objective This feasibility trial aimed to obtain the necessary data and operational experience to finalise the planning of a future definitive multicentre randomised controlled trial. Design Randomised controlled feasibility trial. Participants were block randomised 1 : 1. Researcher-blinded assessments were scheduled at baseline and at 15 and 27 weeks post randomisation. As is appropriate in a feasibility trial, statistical analyses were descriptive rather than involving formal/inferential comparisons. The qualitative elements utilised template analysis as the chosen analytical framework. Setting Four sites across the UK. Participants Eligibility criteria included having a diagnosis of secondary progressive MS, an Expanded Disability Status Scale (EDSS) score of between ≥ 4.0 and ≤ 7.0 points and a self-report of two or more falls in the preceding 6 months. Interventions Intervention – manualised 13-week education and exercise programme (BRiMS) plus usual care. Comparator – usual care alone. Main outcome measures Trial feasibility, proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls), feasibility of the BRiMS programme (via process evaluation) and economic data. Results A total of 56 participants (mean age 59.7 years, standard deviation 9.7 years; 66% female; median EDSS score of 6.0 points, interquartile range 6.0–6.5 points) were recruited in 5 months; 30 were block randomised to the intervention group. The demographic and clinical data were broadly comparable at baseline; however, the intervention group scored worse on the majority of baseline outcome measures. Eleven participants (19.6%) withdrew or were lost to follow-up. Worsening of MS-related symptoms unrelated to the trial was the most common reason (n = 5) for withdrawal. Potential primary and secondary outcomes and economic data had completion rates of > 98% for all those assessed. However, the overall return rate for the patient-reported falls diary was 62%. After adjusting for baseline score, the differences between the groups (intervention compared with usual care) at week 27 for the potential primary outcomes were MS Walking Scale (12-item) version 2 –7.7 [95% confidence interval (CI) –17.2 to 1.8], MS Impact Scale (29-item) version 2 (MSIS-29vs2) physical 0.6 (95% CI –7.8 to 9) and MSIS-29vs2 psychological –0.4 (95% CI –9.9 to 9) (negative score indicates improvement). After the removal of one outlier, a total of 715 falls were self-reported over the 27-week trial period, with substantial variation between individuals (range 0–93 falls). Of these 715 falls, 101 (14%) were reported as injurious. Qualitative feedback indicated that trial processes and participant burden were acceptable, and participants highlighted physical and behavioural changes that they perceived to result from undertaking BRiMS. Engagement varied, influenced by a range of condition- and context-related factors. Suggestions to improve the utility and accessibility of BRiMS were highlighted. Conclusions The results suggest that the trial procedures are feasible and acceptable, and retention, programme engagement and outcome completion rates were sufficient to satisfy the a priori progression criteria. Challenges were experienced in some areas of data collection, such as completion of daily diaries. Future work Further development of BRiMS is required to address logistical issues and enhance user-satisfaction and adherence. Following this, a definitive trial to assess the clinical effectiveness and cost-effectiveness of the BRiMS intervention is warranted. Trial registration Current Controlled Trials ISRCTN13587999. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 27. See the NIHR Journals Library website for further project information.

Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial

“…Whilst there are no recommendations as to what comprises effective training associated with delivery of a RCT, commonality exists in the barriers to trial success, such as clinical and personal equipoise, gatekeeping, the impact of clinicians’ beliefs and attitudes and unconscious bias [ 59 , 60 ]. Web-based training for treating therapists, with multi-modal learning formats, has been used successfully in other rehabilitation trials [ 61 , 62 ]. An advantage of web-based training is that it could keep training costs to a minimum without compromising quality and effectiveness.…”

“…An advantage of web-based training is that it could keep training costs to a minimum without compromising quality and effectiveness. Peer support can be effective in clinical practice [ 61 , 63 ] and might also translate into the research arena, although this has yet to be investigated. Development of a core set of standards for training in stroke rehabilitation trials could help optimise successful delivery.…”

Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial

“…[9][10][11] The importance of targeting a variety of modifiable risk factors through fall prevention programmes for PwMS has been highlighted. 12 The need for comprehensive approaches to fall prevention that address physical, environmental and behavioural aspects of falls management has been echoed by Gunn et al 13 Despite the recognition of the value of attention to diverse influences on fall risk, most fall prevention interventions for PwMS focus only on addressing physical impairments, such as compromised balance. 14 For PwMS, who live with an unpredictable disease and daily fluctuations in functioning, the benefits of self-management 15 16 of the multifactorial fall risks have been highlighted.…”

“… 17 18 Nevertheless, research on self-management interventions to prevent falls in PwMS is in its infancy. The delivery and settings of previous interventions have been face to face in physical locations 19 20 supported by online resources 13 21 22 or web-based without any in real time interactions. 23 Self-management interventions can be enhanced by digital health technologies such as in real time digital meetings and online learning platforms.…”

Physiotherapy for Multiple Sclerosis Patients From Early to Transition Phase: A Scoping Review

“…Generally, interventions have been resource-demanding, requiring regular monitored sessions with a physical therapist or sports therapist in outpatient or clinical settings, as well as the use of costly equipment that cannot be utilized at home [ 28 ]. The value of healthcare provision has been found to rise significantly when condition severity/immobility rises [ 29 ]. People with significant physical limitations ensure efficient self-management approaches that are cost-effective and feasible to apply to maximize their physical activity participation [ 28 ].…”