VA San Diego Healthcare System, San Diego, CA, USA.
University of California San Diego, San Diego, CA, USA.
Clin Trials. 2020 Oct;17(5):581-594. doi: 10.1177/1740774520931864. Epub 2020 Jun 27.
BACKGROUND/AIMS: Age-related cognitive decline is a pervasive problem in our aging population. To date, no pharmacological treatments to halt or reverse cognitive decline are available. Behavioral interventions, such as physical exercise and Mindfulness-Based Stress Reduction, may reduce or reverse cognitive decline, but rigorously designed randomized controlled trials are needed to test the efficacy of such interventions.
Here, we describe the design of the Mindfulness, Education, and Exercise study, an 18-month randomized controlled trial that will assess the effect of two interventions-mindfulness training plus moderate-to-vigorous intensity exercise or moderate-to-vigorous intensity exercise alone-compared with a health education control group on cognitive function in older adults. An extensive battery of biobehavioral assessments will be used to understand the mechanisms of cognitive remediation, by using structural and resting state functional magnetic resonance imaging, insulin sensitivity, inflammation, and metabolic and behavioral assessments.
We provide the results from a preliminary study (n = 29) of non-randomized pilot participants who received both the exercise and Mindfulness-Based Stress Reduction interventions. We also provide details on the recruitment and baseline characteristics of the randomized controlled trial sample (n = 585).
When complete, the Mindfulness, Education, and Exercise study will inform the research community on the efficacy of these widely available interventions improve cognitive functioning in older adults.
背景/目的:与年龄相关的认知能力下降是我们老龄化人口中普遍存在的问题。迄今为止,尚无可用于阻止或逆转认知能力下降的药物治疗方法。行为干预措施,如体育锻炼和正念减压,可能会减少或逆转认知能力下降,但需要进行严格设计的随机对照试验来测试这些干预措施的疗效。
在这里,我们描述了正念、教育和锻炼研究的设计,这是一项为期 18 个月的随机对照试验,将评估两种干预措施(正念训练加中等到剧烈强度的运动或中等到剧烈强度的运动)的效果与健康教育对照组相比,对老年人的认知功能。将使用广泛的生物行为评估来了解认知矫正的机制,包括结构和静息状态功能磁共振成像、胰岛素敏感性、炎症以及代谢和行为评估。
我们提供了一项初步研究(n=29)的结果,该研究对接受运动和正念减压干预的非随机试点参与者进行了研究。我们还详细介绍了随机对照试验样本(n=585)的招募和基线特征。
当正念、教育和锻炼研究完成时,它将为研究界提供有关这些广泛可用的干预措施在改善老年人认知功能方面的疗效的信息。