Exercise Trial for Alzheimer's Disease (EXTRA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Effect of exercise on cognitive decline
研究概览
简要总结
Exercise Trial for Alzheimer's Disease(EXTRA) is a pilot randomized clinical trial involving a physcial activity program versus a healthy lifestyle program, with one year follow-up in 30 non-disabled, community-dwelling persons, age 65 and older.
详细描述
Alzheimer's disease (AD) occurs in 1 in 7 individuals over 65, and 1 in 2 individuals over 85. While the progression of AD is extremely variable, it is generally established that AD subjects will move from having compromised function in socail and work settings, to requiring institutionalization and/or intensive management within 10 years of initial clinical diagnosis. A randomized controlled piot trial is needed to provide information regarding exercies effects on individuals with mild to moderate Alzheimer's disease.
Exercise Trial for Alzheimer's Disease (EXTRA) is a pilot randomized controlled trial designed to compare a moderate-intesity physical activity program to a healthy lifestyle health education program in 30 older adults with mild to moderate Alzheimer's Disease. These individuals will be followed for 1 year.
This trial will provide pilot evidence regarding whether physical activity is effective and practical for individuals with AD. The effects of an exercise intervention on halting, slowing, or reversing the cognitive effects of AD will be assessed with pilot data and potentially provide support for a larger trial in the future.
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 (Investigator)
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
- •65 years and older
- •must be planning to reside in the area for 1 year
- •summary scor of greater than or equal to 3 on the Short Physical Performance Battery (SPPB)
- •have mild to moderate AD defined by a score of 12-24 on the Mini-Mental Status Examination (MMSE). Diagnosis of probable AD from site physician utilizing the following criteria: Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for Dementia of Alzheimer's Type, National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) Criteria for Probable Alzheimer's Disease, and Hachinski Ischemic Score is less than or equal to 4
- •sedentary lifestyle which is operationally defined as spending less than 20 minutes a week in the past month getting regular physical activity.
- •must be willing to give informed consent, be willing to be randomized to either physical activity or health lifestyle intervention, and to follow the protocol for the group to which they have been assigned
排除标准
- •unable or unwilling to give informed consent or accept randomization in either study group
- •current diagnosis of schizophreniz, other psychotic disorders, or bipolar disorder
- •current consumption of more than 14 alcoholic drinks per week
- •plans to relocate to out of the study area within the next year or plans to be out of the study area for more than 6 weeks in the next year
- •score of greater than 3 on SPPB
- •another member of the household is a participant in they study
- •residence too far from the intervention site
- •difficulty in communication with study personnel due to speech or hearing problems
- •MMSE less than 12 or greater than 24
- •currently enrolled in another randomized trial involving lifestyle or phamaceutical interventions
- •other medical, psychiatric, or behavioral factors that in the judgement of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
结局指标
主要结局
Effect of exercise on cognitive decline
时间窗: 6 months
The primary hypothesis is that exercise will decrease the congnitive decline in activities of daily living, in the subjects with Alzheimer's Disease.
次要结局
- Evidence based feasibility for conducting exercise interventions in the Alzheimer's Disease population.(6 months)
- Measuring the effects of exercise on depression, metabolic indices, and changes in overall function.(6 months)