Lifestyle, CVD Risk, and Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in Executive Function
研究概览
简要总结
ENLIGHTEN will examine the effects of exercise, the dietary approaches to stop hypertension diet (DASH), and a combined exercise and DASH intervention on cognitive function among adults with cardiovascular disease (CVD) risk and cognitive deficits. Participants will be randomized to one of the three treatments, or a health education control condition, for 6 months, and will complete assessments of CVD health and cognitive function before and after treatment.
详细描述
Cardiovascular disease (CVD) is the leading cause of death and disability in the United States, affecting more than 81 million American adults. It is well established that risk factors such as hypertension, diabetes, and hyperlipidemia not only place individuals at risk for CVD, but also place them at risk for neurocognitive impairment and dementia. CVD risk factors have been shown to be associated with a cascade of neurophysiologic and neuroanatomic changes, resulting in cognitive impairment and dementia. Exercise and diet have been shown to improve CVD risk factors and also appear particularly promising lifestyle approaches for preventing dementia among individuals at risk, such as those with cognitive impairment, no dementia (CIND). ENLIGHTEN is a randomized clinical trial of diet and exercise among patients with CIND.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 years or older
- •Sedentary
- •Score of 19-25 on the Montreal Cognitive Assessment Battery or verbal fluency score of =< 12 or animal fluency score of =<15
- •At least one cardiovascular risk factor (hypertension, diabetes, cholesterol, obesity, current smoking, or family history) or a documented history of cardiac disease (myocardial infarction, coronary artery bypass grafting, peripheral vascular disease, >70% stenosis, or mild stroke without residual deficit)
排除标准
- •Any significant neurological disease other than CIND, such as Parkinson's disease, multi-infarct dementia, Huntington' s disease, progressive supranuclear palsy, brain tumor, normal pressure hydrocephalus, subdural hematoma, seizure disorder, multiple sclerosis, or history of head trauma with persistent neurological deficits
- •Psychotic disorder within the past two years (DSM IV criteria) or acutely suicidal
- •History of alcohol or substance abuse or dependence within the past two years (DSM IV criteria)
- •History of schizophrenia
- •Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol including a history of systemic cancer within the past 5 years (nonmetastatic skin cancers are acceptable)
- •Myocardial infarction (within the past 3 months) or unstable or severe congestive heart failure (e.g. class III-IV heart failure)
- •End-stage pulmonary disease; uncontrolled diabetes mellitus or uncontrolled hypertension(systolic BP>170 or diastolic BP >100 mm Hg on medication)
- •Musculoskeletal disorders precluding the ability to exercise (e.g. severe arthritis)
研究组 & 干预措施
DASH diet
干预措施: DASH diet (Behavioral)
Combined aerobic exercise and DASH diet
干预措施: Aerobic Exercise (Behavioral)
Combined aerobic exercise and DASH diet
干预措施: DASH diet (Behavioral)
Health education control
干预措施: Health education control (Other)
Aerobic Exercise
干预措施: Aerobic Exercise (Behavioral)
结局指标
主要结局
Change in Executive Function
时间窗: Baseline to post-treatment assessment at 6 months
Composite executive function measure includes Trail Making Test, Stroop Test, Digit Span, Digit Symbol Substitution Test, Ruff 2 \& 7 Test, and Animal Naming Test
次要结局
- Flow-mediated dilation of the brachial artery(6 months)
- Blood Pressure(6 months)
- Inflammation(6 months)
- Intima-medial thickness(6 months)
- Change in Memory(6 months)
- Change in Language(6 months)
- Functional Capacity(6 months)
- Arterial Stiffness(6 months)
- Cholesterol(6 months)
- Fasting glucose(6 months)