A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial
A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial
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DOI：
10.1016/s0140-6736(15)60461-5
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发表时间：
2015-06-06
期刊：
影响因子：
168.9
通讯作者：
Kivipelto, Miia
中科院分区：
文献类型：
--
作者：
Ngandu, Tiia;Lehtisalo, Jenni;Kivipelto, Miia
背景在观察性研究中，可改变的血管和生活方式相关的危险因素与痴呆症风险相关。在芬兰老年干预研究预防认知损害和残疾(Finger)，这是一项概念验证随机对照试验，我们的目标是评估一种多领域方法来预防普通人群中高危老年人的认知衰退。方法在一项双盲随机对照试验中，我们招募了从以前的国家调查中招募的60-77岁的个体。纳入标准为CAIDE(心血管危险因素、老龄化和痴呆)痴呆症风险评分至少6分，认知水平平均或略低于预期年龄。我们以1：1的比例随机将参与者分配到为期两年的多领域干预(饮食、运动、认知训练、血管风险监测)或对照组(一般健康建议)。计算机生成的分配是在每个地点以四人为一组(每组随机分配两个人)进行的。小组分配没有主动向参与者披露，结果评估员对小组分配遮盖了。主要结果是认知功能的改变，通过综合神经心理测试组合(NTB)Z评分来衡量。分析采用改良的治疗意向(所有参与者至少有一次基线后观察)。这项试验在ClinicalTrials.gov上注册，编号NCT01041989。结果在2009年9月7日至2011年11月24日期间，我们筛选了2654人，并将1260人随机分配到干预组(n=631)或对照组(n=629)。干预组中有591人(94%)和对照组中有599人(95%)至少有一次基线后评估，并纳入了修改后的意向治疗分析。两年后，干预组NTB总Z评分的平均变化为0.20(SE 0.02，SD 0.51)，对照组为0.16(0.01，0.51)。NTB总分每年变化的组间差异为0.022(95%CI为0.002~0.042，p=0.030)。153人(12%)整体退学。在干预组中，46名(7%)参与者发生了不良事件，而对照组中只有6名(1%)参与者发生了不良事件；最常见的不良事件是肌肉骨骼疼痛(32名接受干预的人[5%]，没有接受干预的人)。这项大型、长期、随机对照试验的解释结果表明，多领域干预可以改善或维持普通人群中高危老年人的认知功能。
Background Modifiable vascular and lifestyle-related risk factors have been associated with dementia risk in observational studies. In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a proof-of-concept randomised controlled trial, we aimed to assess a multidomain approach to prevent cognitive decline in at-risk elderly people from the general population.Methods In a double-blind randomised controlled trial we enrolled individuals aged 60-77 years recruited from previous national surveys. Inclusion criteria were CAIDE (Cardiovascular Risk Factors, Aging and Dementia) Dementia Risk Score of at least 6 points and cognition at mean level or slightly lower than expected for age. We randomly assigned participants in a 1: 1 ratio to a 2 year multidomain intervention (diet, exercise, cognitive training, vascular risk monitoring), or a control group (general health advice). Computer-generated allocation was done in blocks of four (two individuals randomly allocated to each group) at each site. Group allocation was not actively disclosed to participants and outcome assessors were masked to group allocation. The primary outcome was change in cognition as measured through comprehensive neuropsychological test battery (NTB) Z score. Analysis was by modified intention to treat (all participants with at least one post-baseline observation). This trial is registered at ClinicalTrials.gov, number NCT01041989.Findings Between Sept 7, 2009, and Nov 24, 2011, we screened 2654 individuals and randomly assigned 1260 to the intervention group (n=631) or control group (n=629). 591 (94%) participants in the intervention group and 599 (95%) in the control group had at least one post-baseline assessment and were included in the modified intention-to-treat analysis. Estimated mean change in NTB total Z score at 2 years was 0.20 (SE 0.02, SD 0.51) in the intervention group and 0.16 (0.01, 0.51) in the control group. Between-group difference in the change of NTB total score per year was 0.022 (95% CI 0.002-0.042, p=0.030). 153 (12%) individuals dropped out overall. Adverse events occurred in 46 (7%) participants in the intervention group compared with six (1%) participants in the control group; the most common adverse event was musculoskeletal pain (32 [5%] individuals for intervention vs no individuals for control).Interpretation Findings from this large, long-term, randomised controlled trial suggest that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population.