Centre for Rehabilitation Research and Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology & Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford OX3 7LD, UK
Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
BMJ. 2018 May 16;361:k1675. doi: 10.1136/bmj.k1675.
To estimate the effect of a moderate to high intensity aerobic and strength exercise training programme on cognitive impairment and other outcomes in people with mild to moderate dementia.
Multicentre, pragmatic, investigator masked, randomised controlled trial.
National Health Service primary care, community and memory services, dementia research registers, and voluntary sector providers in 15 English regions.
494 people with dementia: 329 were assigned to an aerobic and strength exercise programme and 165 were assigned to usual care. Random allocation was 2:1 in favour of the exercise arm.
Usual care plus four months of supervised exercise and support for ongoing physical activity, or usual care only. Interventions were delivered in community gym facilities and NHS premises.
The primary outcome was score on the Alzheimer's disease assessment scale-cognitive subscale (ADAS-cog) at 12 months. Secondary outcomes included activities of daily living, neuropsychiatric symptoms, health related quality of life, and carer quality of life and burden. Physical fitness (including the six minute walk test) was measured in the exercise arm during the intervention.
The average age of participants was 77 (SD 7.9) years and 301/494 (61%) were men. By 12 months the mean ADAS-cog score had increased to 25.2 (SD 12.3) in the exercise arm and 23.8 (SD 10.4) in the usual care arm (adjusted between group difference -1.4, 95% confidence interval -2.6 to -0.2, P=0.03). This indicates greater cognitive impairment in the exercise group, although the average difference is small and clinical relevance uncertain. No differences were found in secondary outcomes or preplanned subgroup analyses by dementia type (Alzheimer's disease or other), severity of cognitive impairment, sex, and mobility. Compliance with exercise was good. Over 65% of participants (214/329) attended more than three quarters of scheduled sessions. Six minute walking distance improved over six weeks (mean change 18.1 m, 95% confidence interval 11.6 m to 24.6 m).
A moderate to high intensity aerobic and strength exercise training programme does not slow cognitive impairment in people with mild to moderate dementia. The exercise training programme improved physical fitness, but there were no noticeable improvements in other clinical outcomes.
Current Controlled Trials ISRCTN10416500.
评估中高强度有氧和力量训练方案对轻度至中度痴呆患者认知障碍及其他结局的影响。
多中心、实用、研究者设盲、随机对照试验。
英国国民保健署初级保健、社区和记忆服务、痴呆症研究登记处以及 15 个英语区域的志愿部门提供者。
494 名痴呆患者:329 名被分配到有氧和力量训练方案,165 名被分配到常规护理。随机分配以 2:1 的比例有利于锻炼组。
常规护理加四个月的监督锻炼和支持持续的身体活动,或仅常规护理。干预措施在社区健身房设施和国民保健署场所提供。
主要结局为 12 个月时阿尔茨海默病评估量表认知分量表(ADAS-cog)的评分。次要结局包括日常生活活动、神经精神症状、健康相关生活质量以及照顾者生活质量和负担。在干预期间,在锻炼组中测量了体能(包括 6 分钟步行测试)。
参与者的平均年龄为 77(SD 7.9)岁,301/494(61%)为男性。12 个月时,锻炼组的 ADAS-cog 评分平均增加到 25.2(SD 12.3),常规护理组增加到 23.8(SD 10.4)(调整后组间差异-1.4,95%置信区间-2.6 至-0.2,P=0.03)。这表明锻炼组的认知障碍更严重,尽管平均差异较小,临床意义不确定。在按痴呆类型(阿尔茨海默病或其他)、认知障碍严重程度、性别和活动能力进行的预先计划的亚组分析中,未发现次要结局或差异。锻炼的依从性良好。超过 65%的参与者(214/329)参加了超过四分之三的预定课程。6 分钟步行距离在 6 周内改善(平均变化 18.1m,95%置信区间 11.6m 至 24.6m)。
中高强度有氧和力量训练方案并不能减缓轻度至中度痴呆患者的认知障碍。锻炼训练方案改善了身体适应性,但在其他临床结局方面没有明显改善。
当前对照试验 ISRCTN8613634。