Exercise for Brain Health in the Fight Against Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Change from Baseline to 6 months in Resting Cerebral Blood Flow
研究概览
简要总结
The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80). Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD). Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC). The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus. The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and outcomes assessors are masked to APOE genotype. We do not share any data with care providers.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 to 80 years old
- •Fluent in English
- •Willingness to make the time commitment to participate in the project, including randomization to treatments
- •Physically inactive (physical activity not more than 2 days per week for the past 6 months)
- •Physician consent to undergo an exercise stress test and engage in moderate intensity exercise
- •Determined to be safe for MRI
排除标准
- •Neurological illnesses/conditions such as cerebral palsy, epi¬lepsy, brain tumor, chronic meningitis, multiple scle¬rosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease
- •Untreated hypertension, glaucoma, and chronic obstructive pul¬monary disease
- •Untreated severe major depression
- •Substance abuse or dependence
- •Current use of psychoactive medications, except selective serotonin/norepinephrine reuptake inhibitor antidepressants
- •Use of acetylcholinesterase inhibitors (e.g., Aricept)
- •Unstable or severe cardiovascular disease or asthmatic condition
- •History of transient ischemic attack, cerebral ischemia, or clinically diagnosed stroke
- •Diagnosis of mild cognitive impairment or dementia, or objective evidence of cognitive impairment
研究组 & 干预措施
Exercise Training
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.
干预措施: Exercise Training (Other)
Flexibility Control
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.
干预措施: Flexibility Control (Other)
结局指标
主要结局
Change from Baseline to 6 months in Resting Cerebral Blood Flow
时间窗: Baseline and 6 months
Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5
时间窗: Baseline and 6 months
Rey Auditory Verbal Learning Test Sum of Trials 1-5
时间窗: Baseline and 6 months
Rey Auditory Verbal Learning Test Sum of Trials 1-5. Fifteen words are presented verbally, and participant is asked to recall as many as possible after each trial. The total sum of the words correctly recalled across trials 1 to 5 is recorded.
Famous Name Discrimination fMRI Activation
时间窗: Baseline and 6 months
Famous minus Not Famous Name Discrimination activation using event-related fMRI (correct trials only), derived from standard preprocessing and control of family-wise error rate. The primary outcome reflects the mean activation intensity from all brain regions that were shown to be activated by the task in both the Exercise Training and Flexibility Control conditions.
次要结局
- Change from Baseline to 6 months in VO2peak(Baseline and 6 months)
- Change from Baseline to 6 months in 6 Minute Walk Test(Baseline and 6 months)
- Peak Rate of Oxygen Consumption (VO2peak)(Baseline and 6 months)
- 6 Minute Walk Test(Baseline and 6 months)