Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training (ACT) in MCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 8
- 主要终点
- Executive function
研究概览
简要总结
This multi-site clinical trial occurs at the University of Minnesota and University of Rochester. It tests the efficacy and additive/synergistic effects of an ACT intervention on cognition and relevant mechanisms (aerobic fitness, Alzheimer's disease [AD] signature cortical thickness, and default mode network [DMN]) in older adults with amnestic MCI (aMCI).
详细描述
Because almost all drug trials for Alzheimer's disease (AD) have failed, developing non-pharmacological interventions with strong potential to prevent or delay the onset of AD in high-risk populations (e.g., those with mild cognitive impairment [MCI]) is critically important. Aerobic exercise and cognitive training are 2 promising interventions for preventing AD. Aerobic exercise increases aerobic fitness, which in turn improves brain structure and function, while cognitive training improves selective neural function intensively. Hence, combined Aerobic exercise and Cognitive Training (ACT) may very well have an additive or synergistic effect on cognition by complementary strengthening of different neural functions. Few studies have tested ACT's effects, and those studies have reported discrepant findings, largely due to varying ACT programs. 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of MCI
- •Community-dwelling
- •Age 65 years and older
- •English-speaking
- •Adequate visual acuity
- •Verified exercise safety by medical provider
- •Stable on drugs affecting cognitive and psychological status
- •Verified MRI safety
- •Capacity to consent
排除标准
- •Geriatric Depression Scale < 5
- •Resting heart rate (HR) ≤50 due to arrhythmia or ≥100 beats/min
- •Neurological (e.g., dementia, head trauma), psychiatric (e.g., bipolar, schizophrenia, or depression), or substance dependency (alcohol or chemical dependency) in the past 5 years that are the main contributor to MCI
- •Contraindications to exercise, e.g. unstable angina, recent surgery
- •New symptoms or diseases that have not been evaluated by a health care provider
- •Current enrollment in another intervention study related to cognitive improvement (reduce confounding effects on outcomes)
- •Abnormal MRI findings
结局指标
主要结局
Executive function
时间窗: Change from baseline to 3, 6, 12, and 18 months
EXAMINER
Episodic memory
时间窗: Change from baseline to 3, 6, 12, and 18 months
RAVLT and BVMTR
AD-signature cortical thickness
时间窗: Change from baseline to 6, 12, and 18 months
Magnetic Resonance Imaging (MRI)
Functional connectivity in DMN
时间窗: Change from baseline to 6, 12, and 18 months
Functional MRI for Default Mode Network
Aerobic fitness
时间窗: Change from baseline to 3, 6, 12, and 18 months
VO2peak from symptom-limited peak cycle-ergometer test, and 10-m Incremental Shuttle Walk Test
Conversion to Alzheimer's disease
时间窗: Change from baseline to 6, 12, and 18 months
Clinical adjudication of Alzheimer's disease dementia
次要结局
未报告次要终点