Nakagawa Satoshi, Kowa Hisatomo, Takagi Yumi, Kakei Yasumasa, Kagimura Tatsuo, Sanada Shoji, Nagai Yoji
Division of Translational Science, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan.
Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Hyogo, Japan.
Contemp Clin Trials Commun. 2024 Jun 14;40:101326. doi: 10.1016/j.conctc.2024.101326. eCollection 2024 Aug.
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).
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.
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.
A non-pharmaceutical multimodal intervention program could contribute to slowing cognitive decline in patients with MCI.
本研究旨在评估一项非药物多模式干预计划的疗效，该计划包括在团体环境中进行体育锻炼、认知刺激和健康教育，以减缓轻度认知障碍（MCI）的进展。
对27例MCI患者进行了单臂干预研究。为评估干预计划的疗效，在8个月干预前后使用欧洲五维健康量表（EQ-5D）、简易精神状态检查表（MMSE）、认知功能量表（CFI）、5项认知测试、抑郁量表和身体机能进行前后分析。此外，利用外部对照患者的MMSE评分数据，进行倾向评分和半贝叶斯分析，以将干预计划与标准医疗护理进行比较。
24例患者完成了干预计划。在研究期间，尽管EQ-5D和MMSE评分保持不变（平均变化0.02 [95%置信区间（CI）：-0.004，0.04]，0.5 [-0.2，1.3]），但CFI和5项认知测试的子类别（注意力和推理）有所改善（平均变化-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下降幅度小于外部对照患者（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]，倾向评分调整后的差异为2.26 [1.46，3.05]。半贝叶斯方法也表明干预减缓了MCI的进展。
一项非药物多模式干预计划可能有助于减缓MCI患者的认知衰退。
