Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI_The ACT Trial COVID Admin Sup

有氧运动和认知训练相结合在 MCI_The ACT Trial COVID Admin Sup 中的功效和机制

• 批准号: 10747055
• 负责人: Feng Vankee Lin
• 金额: $ 40.55万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10747055
• 关键词: Aerobic Exercise; Affect; Alzheimer associated neurodegeneration; Alzheimer disease prevention; Alzheimer' s Disease; American; Brain; Clinical; Cognition; Deterioration; Disease Progression; Educational Intervention; Elderly; Epidemic; Episodic memory; Family member; Future; Goals; Hour; Intention; Intervention; Long-Term Effects; Measures; Mediating; Memory; Modeling; Nervous System; Onset of illness; Participant; Pathologic; Pharmaceutical Preparations; Phase; Prevention Research; Protocols documentation; Randomized; Randomized, Controlled Trials; Rest; Single-Blind Study; Structure; Testing; Thick; Training; amnestic mild cognitive impairment; arm; attentional control; cognitive change; cognitive training; coronavirus disease; design; efficacy evaluation; efficacy testing; executive function; exercise training; improved; prevent; processing speed; programs

Brief Summary of Protocol (5,000 characters max) The purpose of this single-blinded, 2×2 factorial Phase II randomized controlled trial (RCT) is to test the efficacy and additive/synergistic effects of a 6-month combined cycling and speed of processing (SOP) training intervention on cognition and relevant mechanisms (aerobic fitness, AD signature cortical thickness, and functional connectivity in the default mode network [DMN]) in older adults with amnestic MCI (aMCI). Our preliminary studies have shown that enhanced aerobic fitness is associated with better cognition and resting- state functional connectivity in the DMN in AD, and ~20 hours of SOP training improves executive function and maintains functional connectivity in the DMN in aMCI. This RCT will randomize 128 participants equally to 4 arms: ACT, cycling only, SOP training only, or attention control for 6 months, and then follow them for another 12 months. Cognition and aerobic fitness will be assessed at baseline, 3, 6, 12, and 18 months; AD signature cortical thickness and functional connectivity in the DMN at baseline, 6, 12, and 18 months; AD conversion at 3, 6, 12, and 18 months. The specific aims are to: Aim I. Determine the efficacy and additive/synergistic effects of ACT on cognition over 6 months. H1: ACT will have the greatest effects on executive function and episodic memory compared with other groups. Aim II. Examine the underlying mechanisms of ACT over 6 months. H2a: ACT will have the greatest effects on AD signature cortical thickness, functional connectivity in the DMN, and aerobic fitness compared with other groups. H2b: Changes in the mechanistic measures are related to cognitive changes. H2c: Changes in AD signature cortical thickness and DMN mediate aerobic fitness' effects on cognition. Aim III (exploratory). Calculate the long-term effect sizes of ACT on cognition and clinical and pathological AD conversion to inform future Phase III RCTs. Analysis will use intention-to-treat and linear mixed-effect modeling. This trial will be the first to test the synergistic effects on cognition and mechanisms (relevant to AD-associated neurodegeneration) of a uniquely conceptualized and rigorously designed ACT in older adults with aMCI. It will advance AD prevention research by providing precise effect-size estimates of the ACT intervention. Our long-term goal is to delay AD onset and slow AD progression.

协议的简要摘要（最大5,000个字符） 这个单盲2×2阶段II随机对照试验（RCT）的目的是测试 6个月组合循环和加工速度（SOP）训练的有效和添加/协同效应 干预认知和相关机制（有氧运动，AD标志性皮质厚度和 默认MCI（AMCI）的老年人的默认模式网络中的功能连通性[DMN]）。我们的 初步研究表明，增强的有氧健身与更好的认知和静止 - AD中DMN中的状态功能连通性，SOP培训的约20小时可改善执行功能和 在AMCI中保持DMN中的功能连通性。该RCT将随机将128个参与者等于4 武器：ACT，仅骑自行车，仅SOP训练或注意力控制6个月，然后跟随他们进行另一个 12个月。认知和有氧健身将在基线，3、6、12和18个月进行评估；广告签名 基线，6、12和18个月的DMN的皮质厚度和功能连通性；广告转换为 3、6、12和18个月。具体目的是：目标I。确定效率和添加剂/协同作用 在6个月内对认知行为的行为。 H1：ACT对执行功能和情节的影响最大 与其他组相比，记忆。目标II。检查6个月内ACT的潜在机制。 H2A： ACT将对AD标志性皮质厚度，DMN的功能连通性具有最大的影响，并且 有氧健身与其他组相比。 H2B：机械措施的变化与 认知变化。 H2C：AD标志性皮质厚度和DMN的变化介导有氧健身的效果 关于认知。 AIM III（探索性）。计算ACT对认知和临床的长期效应大小以及 病理广告转化以告知未来的III阶段RCT。分析将使用意向治疗和线性 混合效应建模。该试验将是第一个测试对认知和机制的协同影响的试验。 （与广告相关的神经变性有关）独特概念化和严格设计的行为 AMCI的老年人。它将通过提供精确的效应尺寸估计值来推动AD预防研究 ACT干预。我们的长期目标是延迟AD发作并减缓AD的进展。