Efficacy of a non-pharmaceutical multimodal intervention program in a group setting for patients with mild cognitive impairment: A single-arm interventional study with pre-post and external control analyses

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-06-14 DOI:10.1016/j.conctc.2024.101326

Satoshi Nakagawa , Hisatomo Kowa , Yumi Takagi , Yasumasa Kakei , Tatsuo Kagimura , Shoji Sanada , Yoji Nagai

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引用次数: 0

Abstract

Aim

This study aimed to evaluate the efficacy of a non-pharmaceutical multimodal intervention program consisting of physical exercise, cognitive stimulation, and health education in a group setting to slow the progression of mild cognitive impairment (MCI).

Methods

A single-arm interventional study was conducted on 27 patients with MCI. To evaluate the efficacy of the intervention program, a pre-post analysis was performed using EuroQol-5 Dimension (EQ-5D), Mini-Mental State Examination (MMSE), Cognitive Function Instrument (CFI), 5 Cog test, depression, and physical performance before and after the 8-month intervention. Additionally, propensity score and the semi-Bayes analyses were performed to compare the intervention program with standard medical care, using the external control patients’ data for MMSE scores.

Results

Twenty-four patients completed the intervention program. During the study period, although EQ-5D and MMSE scores remained unchanged (mean change 0.02 [95 % confidence interval (CI): −0.004, 0.04], 0.5 [-0.2, 1.3]), CFI and the subcategories of 5Cog (attention and reasoning) improved (mean change −1.23 [-2.24, −0.21], 4.3 [0.9, 7.7], 3.0 [0.4, 5.6]). In the additional analysis comparing changes in MMSE scores, patients who underwent the intervention program had less decline than the external control patients (mean change −1.7 [-2.1, −1.3]) with an observed mean difference of 2.25 [1.46, 3.03], and propensity score-adjusted difference of 2.26 [1.46, 3.05]. The semi-Bayesian approach also suggested that the intervention slowed the progression of MCI.

Conclusion

A non-pharmaceutical multimodal intervention program could contribute to slowing cognitive decline in patients with MCI.

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针对轻度认知障碍患者的集体非药物多模式干预计划的疗效：单臂干预研究，前后期和外部对照分析

目的本研究旨在评估由体育锻炼、认知刺激和健康教育组成的非药物多模式干预计划对减缓轻度认知障碍（MCI）进展的疗效。方法对 27 名 MCI 患者进行了单臂干预研究。为了评估干预计划的疗效，研究人员在为期 8 个月的干预前后，使用欧洲量表 5 维度（EQ-5D）、迷你精神状态检查（MMSE）、认知功能测试（CFI）、5 Cog 测试、抑郁和体能表现进行了前后分析。此外，还利用外部对照组患者的 MMSE 评分数据进行了倾向得分和半贝叶斯分析，以比较干预计划和标准医疗护理。在研究期间，虽然 EQ-5D 和 MMSE 分数保持不变（平均变化为 0.02 [95 % 置信区间 (CI)：-0.004, 0.04]、0.5 [-0.2, 1.3]），但 CFI 和 5Cog 的子类别（注意力和推理能力）有所改善（平均变化为-1.23 [-2.24, -0.21], 4.3 [0.9, 7.7]、3.0 [0.4, 5.6]）。在比较 MMSE 评分变化的附加分析中，接受干预计划的患者比外部对照组患者的评分下降幅度要小（平均变化-1.7 [-2.1, -1.3]），观察到的平均差异为 2.25 [1.46, 3.03]，倾向得分调整后的差异为 2.26 [1.46, 3.05]。半贝叶斯方法也表明，干预措施减缓了MCI的进展。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.