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.

方案摘要（最多5，000个字符） 这项单盲、2×2析因II期随机对照试验（RCT）的目的是检验 为期6个月的循环和处理速度（SOP）培训的功效和附加/协同效应 干预认知和相关机制（有氧健身，AD签名皮质厚度， 默认模式网络[DMN]中的功能连接）。我们 初步研究表明，增强有氧健身与更好的认知和休息有关， AD患者DMN中的状态功能连接，约20小时的SOP培训可改善执行功能， 在aMCI中保持DMN中的功能连接。该RCT将随机分配128名参与者，平均分配4名 手臂：ACT，仅循环，仅SOP培训或注意力控制6个月，然后再随访一个月 12个月将在基线、3、6、12和18个月时评估认知和有氧健身; AD特征 基线、6、12和18个月时DMN的皮质厚度和功能连接; 3、6、12和18个月。具体目标是：确定效力和累加/协同效应 对认知能力的影响。H1：ACT将对执行功能和情节产生最大影响 与其他群体相比。Aim II.检查ACT的潜在机制超过6个月。H2a： ACT将对AD特征皮质厚度、DMN中的功能连接性以及 有氧健身与其他组相比。H2 b：机制措施的变化与以下方面有关： 认知变化H2 c：AD特征皮质厚度和DMN的变化介导有氧健身的影响 关于认知。目标三（探索性）。计算ACT对认知和临床的长期效应量， 病理性AD转化，为未来的III期RCT提供信息。分析将使用意向治疗和线性 混合效果建模这项试验将是第一次测试对认知和机制的协同作用 （与AD相关的神经退行性变相关）的独特概念化和严格设计的ACT， 老年人aMCI它将通过提供精确的效应大小估计来推进AD预防研究。 ACT干预。我们的长期目标是延迟AD发作和减缓AD进展。