Physical Exercise and Prevention of Cognitive Decline in Subjects at Risk of Dementia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Change of Mini Mental State Examination (MMSE) score from baseline to 48 months
研究概览
简要总结
The principal aim of this study is to verify whether a program of supervised, multimodal physical exercise improves cognitive function and/or reduces the rate of cognitive decline in older adults
详细描述
Community-dwelling volunteers, recruited from social centers, were invited to an in-person assessment that included a medical history questionnaire and examination, anthropometric measurements, blood tests for cardiovascular risk, and several outcome measures. Participants meeting the inclusion criteria were divided in 3 groups (participants without subjective or objective cognitive impairment, with subjective memory complaints and with mild cognitive impairments) and randomly assigned (1:1) to an experimental group or a control group, using a list of random numbers generated by a statistical software. The list was kept in a sealed envelope and a researcher, not directly involved in the recruitment and in the evaluation of the participants, assigned the allocation numbers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 50 years old
排除标准
- •Medical conditions that compromise survival or limit physical activity
- •Geriatric Depression Scale-15 score of 6 or higher
- •Alcohol intake > 4 units/day
- •Mini- Mental State Examination < 24
- •Clinical Dementia Rating score of 1 or more
结局指标
主要结局
Change of Mini Mental State Examination (MMSE) score from baseline to 48 months
时间窗: Baseline and every 6-12 months, over an intervention period of 48 months
Scale for grading cognitive function
次要结局
- Change of neuropsychological test battery from baseline to 48 months(Baseline and every 6 -12 months, over an intervention period of 48 months)
- Change of Memory Complaint Questionnaire (MAC-Q) from baseline to 48 months(Baseline and every 6 -12 months, over an intervention period of 48 months)
- Change of Geriatric Depression Scale (GDS) from baseline to 48 months(Baseline and every 6 -12 months, over an intervention period of 48 months)
- Change of Short-form Health Survey (SF-36) from baseline to 48 months(Baseline and every 6 -12 months, over an intervention period of 48 months)
- Change of Physical Activity Scale for the Elderly (PASE) from baseline to 48 months(Baseline and every 6 -12 months, over an intervention period of 48 months)
- Change of AAHPERD (American Alliance for Health, Physical Education, Recreation and Dance) fitness test battery from baseline to 48 months(Baseline and every 6 -12 months, over an intervention period of 48 months)
研究者
Alfonso Di Costanzo, MD
MD, Professor of Neurology
University of Molise