School of Health Professions, Faculty of Health and Human Sciences, Peninsula Allied Health Centre, University of Plymouth, Plymouth, UK.
School of Psychology, Faculty of Health and Human Sciences, University of Plymouth, Plymouth, UK.
Health Technol Assess. 2019 Jun;23(27):1-166. doi: 10.3310/hta23270.
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 ( = 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 ; Vol. 23, No. 27. See the NIHR Journals Library website for further project information.
背景:平衡、移动障碍和跌倒在多发性硬化症(MS)患者中很常见。我们正在进行的研究导致了平衡纠正多发性硬化症(BRiMS)的发展,这是一个为期 13 周的家庭和小组为基础的锻炼和教育计划,旨在改善平衡并鼓励更安全的移动。 目的:这项可行性试验旨在获得必要的数据和操作经验,最终规划未来的多中心随机对照试验。 设计:随机对照可行性试验。参与者按 1:1 进行分组随机化。研究人员在基线和随机分组后 15 和 27 周进行盲法评估。在可行性试验中,统计分析是描述性的,而不是涉及正式/推断性比较。定性元素使用模板分析作为选择的分析框架。 地点:英国的四个地点。 参与者:符合条件的参与者包括患有继发性进展性 MS、扩展残疾状况量表(EDSS)评分在 4.0 到 7.0 分之间以及在前 6 个月报告有两次或更多次跌倒的自我报告。 干预措施:干预措施-手册化的 13 周教育和锻炼计划(BRiMS)加常规护理。对照组-仅常规护理。 主要观察指标:试验可行性、拟议的最终试验结果(包括 MS、移动性、生活质量和跌倒的影响)、BRiMS 计划的可行性(通过过程评估)和经济数据。 结果:在 5 个月内招募了 56 名参与者(平均年龄 59.7 岁,标准差 9.7 岁;66%为女性;中位数 EDSS 评分为 6.0 分,四分位间距为 6.0-6.5 分);30 名被随机分组到干预组。基线时两组的人口统计学和临床数据基本相似;然而,干预组在大多数基线结果测量中得分较差。11 名参与者(19.6%)退出或失访。与试验无关的 MS 相关症状恶化是退出的最常见原因(5 人)。潜在的主要和次要结局以及经济数据的所有评估对象的完成率均>98%。然而,患者报告跌倒日记的总回复率为 62%。调整基线评分后,潜在主要结局的组间差异(干预组与常规护理组)在第 27 周为:多发性硬化症行走量表(12 项)版本 2-7.7[95%置信区间(CI)-17.2 至 1.8],多发性硬化症影响量表(29 项)版本 2(MSIS-29vs2)身体-0.6(95%CI-7.8 至 9)和 MSIS-29vs2 心理-0.4(95%CI-9.9 至 9)(负分表示改善)。在排除一个异常值后,在 27 周的试验期间共报告了 715 次跌倒,个体之间存在很大差异(范围为 0-93 次跌倒)。在这 715 次跌倒中,101 次(14%)报告为受伤。定性反馈表明试验过程和参与者负担是可以接受的,参与者强调了他们认为由于进行 BRiMS 而导致的身体和行为变化。参与度各不相同,受到一系列与病情和环境相关的因素的影响。突出了提高 BRiMS 的实用性和可及性的建议。 结论:结果表明,试验程序是可行和可接受的,保留率、计划参与度和结果完成率足以满足预先设定的进展标准。在一些数据收集领域,如日常日记的完成,遇到了挑战。 未来工作:需要进一步开发 BRiMS 以解决后勤问题,并提高用户满意度和依从性。在此之后,需要进行一项评估 BRiMS 干预措施的临床有效性和成本效益的确定性试验。 试验注册:当前对照试验 ISRCTN85143207。 资金:该项目由英国国家卫生研究院(NIHR)健康技术评估计划资助,将在;第 23 卷,第 27 期。请访问 NIHR 期刊库网站以获取更多项目信息。
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