Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE): Protocol
Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE): Protocol
复制标题
DOI：
10.1016/j.cct.2019.105832
复制
发表时间：
2019-10-01
影响因子：
2.2
通讯作者：
Wollam, Mariegold E.
中科院分区：
文献类型：
--
作者：
Erickson, Kirk I.;Grove, George A.;Wollam, Mariegold E.
尽管普遍存在与年龄相关的正常认知能力下降，但缺乏有效的方法来改善神经认知健康。幸运的是，中等强度的运动是一种很有希望改善晚年大脑和认知健康的方法，但由于缺乏大规模、全面的III期临床试验，它的有效性仍然是一个怀疑和争论的问题。在这里，我们描述了这样一个随机临床试验的方案，该试验被称为IGNITE（在运动干预试验中调查神经认知的增益），这项研究能够更明确地解决运动是否影响认知正常老年人的认知和大脑健康。我们正在进行一项为期12个月，多地点，随机剂量反应运动试验，在639名65至80岁认知正常的成年人中进行。参与者被随机分为(1)中等强度有氧运动150分钟/周（N = 213），(2)中等强度有氧运动225分钟/周（N = 213），或(3)低强度拉伸和调节控制150分钟/周（N = 213）。参与者每周进行3天有监督的锻炼，每周进行2天无监督的锻炼，持续12个月。在基线、6个月和12个月时评估全面的认知能力、血液生物标志物和社会心理问卷。此外，在基线和12个月的随访中评估脑磁共振成像、生理生物标志物、心肺健康、身体功能和淀粉样蛋白沉积的正电子发射断层扫描。这项试验的结果可以改变以科学为基础的政策和卫生保健建议，以改善认知正常老年人的认知功能。
Despite the ubiquity of normal age-related cognitive decline there is an absence of effective approaches for improving neurocognitive health. Fortunately, moderate intensity exercise is a promising method for improving brain and cognitive health in late life, but its effectiveness remains a matter of skepticism and debate because of the absence of large, comprehensive, Phase III clinical trials. Here we describe the protocol for such a randomized clinical trial called IGNITE (Investigating Gains in Neurocognition in an Intervention Trial of Exercise), a study capable of more definitively addressing whether exercise influences cognitive and brain health in cognitively normal older adults. We are conducting a 12-month, multi-site, randomized dose-response exercise trial in 639 cognitively normal adults between 65 and 80 years of age. Participants are randomized to (1) a moderate intensity aerobic exercise condition of 150 min/week (N = 213), (2) a moderate intensity aerobic exercise condition at 225 min/week (N = 213), or (3) a light intensity stretching-and-toning control condition for 150 min/week (N = 213). Participants are engaging in 3 days/week of supervised exercise and two more days per week of unsupervised exercise for 12 months. A comprehensive cognitive battery, blood biomarkers and battery of psychosocial questionnaires is assessed at baseline, 6 and 12-months. In addition, brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and positron emission tomography of amyloid deposition are assessed at baseline and at the 12-month follow-up. The results from this trial could transform scientific-based policy and health care recommendations for approaches to improve cognitive function in cognitively normal older adults.