Aerobic Exercise in Alzheimer's Disease: Cognition and Hippocampal Volume Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change in cognition from baseline to 6 months as measured by the Alzheimer's Disease Assessment Scale - Cognitive Subscale
研究概览
简要总结
This randomized controlled trial (RCT) will investigate the effects of a 6-month, individualized, moderate-intensity cycling intervention on cognition and hippocampal volume in AD with three aims:
- Determine the immediate effect of the cycling intervention on cognition in AD.
- Examine if the cycling intervention slows cognitive decline in AD from baseline to 12 months.
- Assess the effect of aerobic exercise on hippocampal volume in AD over 12 months using MRI.
The investigators will randomize 90 participants to the 6-month cycling or stretching/range of motion exercise (20-50-minute, 3 times a week). Participants will then be followed for another 6 months. Cognition will be assessed at baseline, 3, 6, 9, and 12 months and hippocampal volume will be measured using magnetic resonance imaging (MRI) at baseline, 6, and 12 months.
详细描述
Aerobic exercise holds great promise for treating cognitive impairment, the hallmark symptom of Alzheimer's disease (AD), because it may attenuate brain atrophy. AD currently affects more than 5 million Americans, costing $203 billion in 2013 and causing poor outcomes such as loss of independence, low quality of life, and nursing home placement. Available drugs have only modest short-term effects on reducing or slowing cognitive impairment in AD. Hence, there is a pressing need to develop and test aerobic exercise interventions for AD. This randomized controlled trial (RCT) will investigate the effects of a 6-month, individualized, moderate-intensity cycling intervention on cognition and hippocampal volume in AD with three aims:
- Determine the immediate effect of the cycling intervention on cognition in AD.
- Examine if the cycling intervention slows cognitive decline in AD from baseline to 12 months.
- Assess the effect of aerobic exercise on hippocampal volume in AD over 12 months using MRI.
The investigators will randomize 90 participants to the 6-month cycling or stretching/range of motion exercise (20-50-minute, 3 times a week). Participants will then be followed for another 6 months. Cognition will be assessed at baseline, 3, 6, 9, and 12 months and hippocampal volume will be measured using magnetic resonance imaging (MRI) at baseline, 6, and 12 months. Transportation will be provided to participants for all study-related activities including exercises. Participants who could not undergo MRI can still participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 66 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable or possible Alzheimer's disease (AD);
- •15≤ Mini-Mental State Examination (MMSE) score ≤26;
- •Clinical Dementia Rating score 0.5-2;
- •Community-dwelling, e.g., homes and assisted living;
- •Age 66 years and older;
- •English-speaking;
- •Verified exercise safety by the primary care providers and the cardiologists if subjects have significant cardiac history;
- •Stable on AD drugs >1 month if AD drugs are prescribed.
排除标准
- •Resting heart rate (HR) ≤50 or ≥100 beats/min;
- •Neurological disorders in the past 5 years;
- •Psychiatric disorders in the past 5 years;
- •Alcohol or chemical dependency in the past 5 years;
- •Contraindications to exercise;
- •New symptoms or diseases that have not been evaluated by a health care provider, e.g., hip fracture, ongoing and unplanned weight loss, severe shortness of breath, deep vein thrombosis, hernia, unhealed sores, joint swelling, pain or trouble walking;
- •Cardiac ischemia or serious arrhythmia on the electrocardiograph during the screening exercise test.
结局指标
主要结局
Change in cognition from baseline to 6 months as measured by the Alzheimer's Disease Assessment Scale - Cognitive Subscale
时间窗: Baseline, 3 months, 6 months, 9 months, and 12 months
This outcome measure will be given to all study participants.
次要结局
- Change in hippocampal volume as measured by Magnetic Resonance Imaging (MRI)(Baseline, 6 months, and 12 months)