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一项为期 18 个月的预防痴呆多模式干预试验:J-MINT PRIME Tamba。

An 18-month multimodal intervention trial for preventing dementia: J-MINT PRIME Tamba.

机构信息

Department of Public Health, Kobe University Graduate School of Health Sciences, Kobe University Graduate School of Health Sciences, Kobe, Hyogo, Japan.

Department of Rehabilitation Science, Kobe University Graduate School of Health Sciences, Kobe, Hyogo, Japan.

出版信息

Alzheimers Dement. 2024 Oct;20(10):6972-6983. doi: 10.1002/alz.14170. Epub 2024 Sep 4.

Abstract

BACKGROUND

The number of people with dementia is increasing in Japan, and establishing evidence for preventing dementia is necessary.

METHODS

This study was a randomized controlled trial in cognitively normal community-dwelling older adults aged 65 to 85 with diabetes and/or hypertension. Participants were randomly assigned in a 1:1 ratio. The intervention group underwent 90 min of group-based weekly physical exercise, cognitive training, nutritional counseling, and vascular risk management for 18 months. The primary endpoint was the change in a cognitive composite score calculated by averaging the z-scores of seven neuropsychological tests from baseline to 18 months.

RESULTS

We randomly assigned 203 participants to two groups, and 178 (87.7%) completed the 18-month follow-up. There was a significant group difference in the cognitive composite score change at 18 months (mean difference 0.16, 95% confidence interval: 0.04 to 0.27; p = 0.009).

DISCUSSION

An 18-month multimodal intervention for older adults at risk of dementia could improve their cognitive function. The trial was registered in the Clinical Trial Registration System (UMIN000041938).

HIGHLIGHTS

Japan-Multimodal Intervention Trial for Prevention of Dementia (J-MINT) PRIME Tamba was a randomized controlled trial to prevent dementia. We provided a multifactorial intervention based on the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) trial methodology. The primary outcome, the cognitive composite score, improved with our intervention. Executive function/processing speed and memory improved in the intervention group. Intervention adherence was high, and no serious adverse events occurred.

摘要

背景

日本痴呆症患者人数不断增加,因此有必要建立预防痴呆症的证据。

方法

这是一项针对认知正常的社区居住的 65 至 85 岁糖尿病和/或高血压老年人的随机对照试验。参与者以 1:1 的比例随机分组。干预组接受每周 90 分钟的团体基础身体锻炼、认知训练、营养咨询和血管风险管理,为期 18 个月。主要终点是从基线到 18 个月时计算的认知综合评分变化,该评分通过平均七项神经心理学测试的 z 分数得出。

结果

我们将 203 名参与者随机分为两组,其中 178 名(87.7%)完成了 18 个月的随访。18 个月时认知综合评分变化存在显著的组间差异(平均差异 0.16,95%置信区间:0.04 至 0.27;p=0.009)。

讨论

针对有痴呆症风险的老年人进行 18 个月的多模式干预可能会改善他们的认知功能。该试验已在临床试验注册系统(UMIN000041938)中注册。

重点

日本多模式干预预防痴呆症试验(J-MINT)是一项预防痴呆症的随机对照试验。我们提供了一种基于芬兰老年干预研究预防认知障碍和残疾(FINGER)试验方法的多因素干预措施。主要结局指标,认知综合评分,随着我们的干预而改善。干预组的执行功能/处理速度和记忆力得到改善。干预依从性高,没有发生严重不良事件。

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