针对多发性硬化症患者的运动加行为改变干预的随机对照试验性研究：“行动起来”研究
Randomised controlled pilot trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the Step it Up study.
作者信息
Hayes Sara, Uszynski Marcin Kacper, Motl Robert W, Gallagher Stephen, Larkin Aidan, Newell John, Scarrott Carl, Coote Susan
机构信息
Department of Clinical Therapies, Faculty of Education and Health Sciences, Health Research Institute, University of Limerick, Limerick, Ireland.
Western Region, Multiple Sclerosis Society of Ireland, Dublin, Ireland.
出版信息
BMJ Open. 2017 Oct 12;7(10):e016336. doi: 10.1136/bmjopen-2017-016336.
OBJECTIVE
To investigate feasibility of multiple sclerosis (MS) exercise guidelines for inactive people with MS (PwMS) and to examine preliminary efficacy for walking. To investigate effect of augmenting that intervention with education based on social cognitive theory (SCT).
DESIGN
Pilot multicentre, double-blind, randomised, parallel, controlled trial.
SETTING
Community-delivered programme.
PARTICIPANTS
Sixty-five physically inactive PwMS walked independently, scored 0-3 on the Patient Determined Disease Steps Scale, had no MS relapse or change in MS medication in 12 weeks.
INTERVENTIONS
10-week exercise plus SCT education (SCT) compared with exercise plus attention control education (CON).
OUTCOME MEASURES
Six-Minute Walk Test (6MWT), Timed Up and Go (TUG) test and Multiple Sclerosis Walking Scale-12 (MSWS-12).
RESULTS
174 expressed interest, 92 were eligible and 65 enrolled (SCT, n=32; CON, n=33). The intervention was feasible and delivered as intended. 68% of SCT group and 50% of control group met the exercise guidelines after intervention. Using linear mixed effects models, intention-to-treat basis, there was insufficient evidence for difference between the groups over the trial (6MWT, p=0.30; TUG, p=0.4; MSWS-12, p=0.8). Using secondary analysis of a cohort with data for≥3 assessments (SCT, n=21; CON, n=20), there was significant treatment effect favouring the intervention group (p=0.04) with mean effect for 6MWT 39.0 m (95% CI 2.26 to 75.73) at 12 weeks and 40.0 m (95% CI 2.3 to 77.8) at 36 weeks. Both groups improved significantly in 6MWT following 10-week intervention (SCT, mean ∆=83.02, SD=60.1, p≤0.01; CON, mean ∆=56.92, SD=73.5, p≤0.01), TUG (SCT, ∆=-0.70, SD=1.25, p≤0.01; CON, ∆=-0.54, SD=0.95, p≤0.01) and MSWS-12 (SCT, ∆=-8.03, SD=16.18, p=0.02; CON, ∆=-0.86, SD=18.74, p=0.81).
CONCLUSIONS
A 10-week exercise programme based on the MS exercise guidelines for improving walking in previously inactive PwMS was feasible. There is marginal evidence of a treatment effect in favour of the exercise plus SCT intervention at 12 and 36 weeks.
TRIAL REGISTRATION NUMBER
NCT02301442; Results.
目的
探讨针对非活动型多发性硬化症患者（PwMS）的多发性硬化症运动指南的可行性，并研究其对步行的初步疗效。研究基于社会认知理论（SCT）的教育对该干预措施的增强效果。
设计
试点多中心、双盲、随机、平行对照试验。
地点
社区实施项目。
参与者
65名身体不活动的PwMS患者，能独立行走，在患者确定疾病阶段量表上得分为0 - 3分，在12周内无MS复发或MS药物变化。
干预措施
10周运动加SCT教育（SCT组）与运动加注意力控制教育（CON组）进行比较。
观察指标
六分钟步行试验（6MWT）、起立行走试验（TUG）和多发性硬化症步行量表 - 12（MSWS - 12）。
结果
174人表示感兴趣，92人符合条件，65人入组（SCT组，n = 32；CON组，n = 33）。干预措施可行且按计划实施。干预后，SCT组68%和对照组50%的患者达到运动指南要求。采用线性混合效应模型，意向性分析，在整个试验过程中两组间差异无充分证据（6MWT，p = 0.30；TUG，p = 0.4；MSWS - 12，p = 0.8）。对有≥3次评估数据的队列进行二次分析（SCT组，n = 21；CON组，n = 20），有显著治疗效果，支持干预组（p = 0.04），12周时6MWT平均效应为39.0米（95%可信区间2.26至75.73），36周时为40.0米（95%可信区间2.3至77.8）。两组在10周干预后6MWT均显著改善（SCT组，平均变化量 = 83.02，标准差 = 60.1，p≤0.01；CON组，平均变化量 = 56.92，标准差 = 73.5，p≤0.01），TUG（SCT组，变化量 = -0.70，标准差 = 1.25，p≤0.01；CON组，变化量 = -0.54，标准差 = 0.95，p≤0.01）和MSWS - 12（SCT组，变化量 = -8.03，标准差 = 16.18，p = 0.02；CON组，变化量 = -0.86，标准差 = 18.74，p = 0.81）。
结论
基于MS运动指南的为期10周的运动计划对改善先前不活动的PwMS患者的步行能力是可行的。在12周和36周时有少量证据表明运动加SCT干预有治疗效果。
试验注册号
NCT02301442；结果
Zotero 插件