Randomised controlled pilot trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the Step it Up study.
Randomised controlled pilot trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the Step it Up study.
复制标题
DOI：
10.1136/bmjopen-2017-016336
复制
发表时间：
2017-10-12
期刊：
影响因子：
2.9
通讯作者：
Coote S
中科院分区：
文献类型：
--
作者：
Hayes S;Uszynski MK;Motl RW;Gallagher S;Larkin A;Newell J;Scarrott C;Coote S
研究多发性硬化症（MS）运动指南对不活动的MS患者（PwMS）的可行性，并检查步行的初步疗效。探讨基于社会认知理论（SCT）的教育干预效果。初步多中心、双盲、随机、平行、对照试验。社区交付的方案。65名身体不活跃的PwMS独立行走，在患者决定的疾病步骤量表上得分为0 - 3，在12周内没有MS复发或MS药物的变化。10-每周运动加SCT教育（SCT）与运动加注意力控制教育（CON）相比。6分钟步行试验（6MWT）、计时起立行走（TUG）试验和多发性硬化症步行量表-12（MSWS-12）。174例患者表示感兴趣，92例合格，65例入组（SCT，n = 32; CON，n = 33）。干预是可行的，并按预期进行。干预后SCT组68%和对照组50%达到运动指南。使用线性混合效应模型，意向治疗基础，试验期间组间差异的证据不足（6MWT，p = 0.30; TUG，p = 0.4; MSWS-12，p = 0.8）。使用具有≥ 3次评估数据的队列的次要分析（SCT，n = 21; CON，n = 20），存在显著的治疗效果，有利于干预组（p = 0.04），第12周时6MWT的平均效果为39.0 m（95% CI 2.26至75.73），第36周时为40.0 m（95% CI 2.3至77.8）。两组在10周的干预后6MWT均显著改善（SCT，平均AUC = 83.02，SD = 60.1，p ≤ 0.01; CON，平均AUC = 56.92，SD = 73.5，p ≤ 0.01），TUG（SCT，λ = − 0.70，SD = 1.25，p ≤ 0.01; CON，λ = − 0.54，SD = 0.95，p ≤ 0.01）和MSWS-12（SCT，λ = − 8.03，SD = 16.18，p = 0.02; CON，λ = − 0.86，SD = 18.74，p = 0.81）。一个为期10周的运动计划的基础上，MS运动指南，以改善步行在以前不活跃的PwMS是可行的。在12周和36周时，有边际证据表明运动加SCT干预的治疗效果有利。NCT 02301442;结果。
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). Pilot multicentre, double-blind, randomised, parallel, controlled trial. Community-delivered programme. 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. 10-week exercise plus SCT education (SCT) compared with exercise plus attention control education (CON). Six-Minute Walk Test (6MWT), Timed Up and Go (TUG) test and Multiple Sclerosis Walking Scale-12 (MSWS-12). 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). 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. NCT02301442; Results.
登录
查看更多内容
DOI：
10.1186/1748-5908-6-42
发表时间：
2011-04-23
期刊：
Implementation science : IS
影响因子：
--
作者：
Michie S;van Stralen MM;West R
通讯作者：
West R
影响因子：
5.8
作者：
Garrett, Maria;Hogan, Neasa;Coote, Susan
通讯作者：
Coote, Susan
影响因子：
7.4
作者：
Hadjimichael, Olympia;Kerns, Robert D.;Vollmer, Timothy
通讯作者：
Vollmer, Timothy
影响因子：
9.9
作者：
Hobart, JC;Riazi, A;Thompson, AJ
通讯作者：
Thompson, AJ
影响因子：
24.3
作者：
Casanova, C.;Celli, B. R.;Aguirre-Jaime, A.
通讯作者：
Aguirre-Jaime, A.