ENLIGHTEN: Exercise and NutritionaL Interventions for coGnitive and Cardiovascular HealTh ENhancement

Not Applicable

Completed

Interventions: Behavioral: Aerobic Exercise
Other: Health education control
Behavioral: DASH diet

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Exclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise	Aerobic Exercise	-
Combined aerobic exercise and DASH diet	DASH diet	-
DASH diet	DASH diet	-
Combined aerobic exercise and DASH diet	Aerobic Exercise	-
Health education control	Health education control	-

Primary Outcome Measures

Name	Time	Method
Change in Executive Function	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

Secondary Outcome Measures

Name	Time	Method
Flow-mediated dilation of the brachial artery	6 months	We also will examine treatment effects on the vascular function measures, including flow-mediated dilation of the brachial artery.
Blood Pressure	6 months	We also will examine treatment effects on the vascular function measures, including blood pressure.
Inflammation	6 months	We will also assess treatment effects on measures of inflammation, including C-reactive protein and interleukin-6.
Intima-medial thickness	6 months	We also will examine treatment effects on the vascular function measures, including intima-medial thickness of the carotid artery.
Change in Memory	6 months	Secondary outcomes will include composite measures of memory (Hopkins Verbal Learning Test-Revised and Medical College of Georgia Complex Figure Test)
Change in Language	6 months	Secondary outcomes will include composite measures of language (Controlled Oral Word Association Test and Animal Naming Test)
Functional Capacity	6 months	Functional capacity (6MWT and peak VO2). Six-minute walk distance (6MWT) and peak VO2 from a treadmill test will be assessed by an exercise physiologist.
Arterial Stiffness	6 months	We also will examine treatment effects on the vascular function measures, including pulse-wave velocity of the femoral artery.
Cholesterol	6 months	We will also examine treatment effects on cholesterol, including LDL, HDL, and total cholesterol
Fasting glucose	6 months	We will also assess treatment effects on measures fasting glucose

Locations (1): Duke University Medical Center
🇺🇸
Durham, North Carolina, United States