The Effects of an Extensive Exercise Program on the Progression of Mild Cognitive Impairment (MCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 3
- 主要终点
- Cognitive performance
研究概览
简要总结
Exercise interventions to prevent dementia and delay cognitive decline have gained considerable attention in recent years. Human and animal studies have demonstrated that regular physical activity targets brain function by increasing cognitive reserve. Although initial studies indicate enhanced cognitive performance in patients with mild cognitive impairment (MCI) following an exercise intervention, little is known about the effect of an extensive, controlled and regular exercise regimen on the neuropathology of patients with MCI.
The aim of this study is to compare a 12- month aerobic exercise programme versus a stretching and toning (non-aerobic) programme versus a control group on the progression of cognitive decline in MCI.
It is hypothesized that MCI-related decreases in cognitive and psychomotor functioning will show less progression or even be improved after a one-year aerobic exercise intervention compared to a group of patients undergoing stretching and toning exercise as well as to a control group provided with no intervention.
详细描述
This randomised controlled clinical intervention study will take place across three European sites; the German Sport University Cologne, Germany, University of Nijmegen, The Netherlands and Trinity College Dublin, Ireland. Seventy-five previously sedentary patients with a clinical diagnosis of MCI will be recruited at each site. Participants will be randomised to one of three intervention arms. One group will receive a standardised one-year extensive aerobic exercise intervention (3 units of 45min / week). The second group will complete stretching and toning (non-aerobic) exercise (3 units of 45min / week) and the third group will receive usual care. Change in all outcomes will be measured at baseline (T0), after six months (T1) and after 12 months (T2).
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) according to the Albert et al (2011) criteria
- •Montreal Cognitive Assessment (MoCA) (Nasreddine et al. 2005) score 18-26
- •Stable medical condition for more than 6 months
- •Stable medications for more than 3 months
- •Adequate visual and auditory acuity to complete neuropsychological testin
- •Electrocardiogram without significant abnormalities that might interfere with the study
- •Physical ability sufficient to allow performance of endurance exercise training
- •Capacity to provide written and dated informed consent form
- •Medical clearance to undergo a symptom-limited cardiopulmonary exercise test and extensive aerobic exercise training
- •Participants recruited from the community via newspaper articles and community advertisement will complete additional testing to determine MCI status. Participants must score ≤1.5 standard deviation (SD) of cut-off scores on episodic memory test
排除标准
- •Diagnosis of AD or other type of dementia
- •History of familial early-onset dementia
- •Enrollment onto any investigational drug study
- •History in the past 2 years of epileptic seizures (Participants with epilepsy who have been stable off medication and seizure free for 2 years may be included)
- •Any major psychiatric disorder (a clinical diagnosis of major depressive disorder, bipolar or schizophrenia)
- •Past history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder
- •Carotid stent or severe stenosis
- •History of myocardial infarction within previous year congestive heart failure (New York Heart Association Class II, III or IV)
- •Uncontrolled hypertension or hypotension (systolic blood pressure >200 mm Hg and/or diastolic blood pressure >110 mm Hg at rest)
- •Unstable cardiac, renal, lung, liver, or other severe chronic disease
- •Type 2 diabetes mellitus with hypoglycemia in the last 3 months
- •Significant history of alcoholism or drug abuse within last 10 years
- •Significant obesity limiting active participation in the exercise program
- •Engagement in moderate-intensity aerobic exercise training for more than 30 minutes, 3 times per week, during past 2 years
- •History of vitamin B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowed)
- •Serious or non-healing wound, ulcer, or bone fracture
结局指标
主要结局
Cognitive performance
时间窗: One year
Cognitive performance will be assessed by an extensive neuropsychological test battery
次要结局
- Brain imaging(6 months)
- Cardiovascular fitness(One year)
- Physical activity(One year)
- Depressive symptoms(One year)
- Timed up and Go (TUG)(One year)
- Global cognitive function(One year)
- Health related Quality of Life(One year)
- Hand grip strength(One year)
- 30 second chair stand(One year)
- Epigenetics(One year)
- Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)(One year)