Clinical trial NCT01573546: ENLIGHTEN: Exercise and NutritionaL Interventions for coGnitive and Cardiovascular HealTh ENhancement
Official title: Lifestyle, CVD Risk, and Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment, no Dementia (CIND)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 160
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Executive Function
timeFrame: Baseline to post-treatment assessment at 6 months
Secondary outcomes:
measure: Change in Memory
timeFrame: 6 months
measure: Change in Language
timeFrame: 6 months
measure: Inflammation
timeFrame: 6 months
measure: Functional Capacity
timeFrame: 6 months
measure: Blood Pressure
timeFrame: 6 months
measure: Flow-mediated dilation of the brachial artery
timeFrame: 6 months
measure: Arterial Stiffness
timeFrame: 6 months
measure: Intima-medial thickness
timeFrame: 6 months
measure: Fasting glucose
timeFrame: 6 months
measure: Cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: James A Blumenthal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blumenthal JA, Smith PJ, Welsh-Bohmer K, Babyak MA, Browndyke J, Lin PH, Doraiswamy PM, Burke J, Kraus W, Hinderliter A, Sherwood A. Can lifestyle modification improve neurocognition? Rationale and design of the ENLIGHTEN clinical trial. Contemp Clin Trials. 2013 Jan;34(1):60-9. doi: 10.1016/j.cct.2012.09.004. Epub 2012 Sep 19.
citation: Blumenthal JA, Smith PJ, Mabe S, Hinderliter A, Welsh-Bohmer K, Browndyke JN, Doraiswamy PM, Lin PH, Kraus WE, Burke JR, Sherwood A. Longer Term Effects of Diet and Exercise on Neurocognition: 1-Year Follow-up of the ENLIGHTEN Trial. J Am Geriatr Soc. 2020 Mar;68(3):559-568. doi: 10.1111/jgs.16252. Epub 2019 Nov 22.
citation: Blumenthal JA, Smith PJ, Mabe S, Hinderliter A, Lin PH, Liao L, Welsh-Bohmer KA, Browndyke JN, Kraus WE, Doraiswamy PM, Burke JR, Sherwood A. Lifestyle and neurocognition in older adults with cognitive impairments: A randomized trial. Neurology. 2019 Jan 15;92(3):e212-e223. doi: 10.1212/WNL.0000000000006784. Epub 2018 Dec 19.
citation: Blumenthal JA, Smith PJ, Mabe S, Hinderliter A, Welsh-Bohmer K, Browndyke JN, Lin PH, Kraus W, Doraiswamy PM, Burke J, Sherwood A. Lifestyle and Neurocognition in Older Adults With Cardiovascular Risk Factors and Cognitive Impairment. Psychosom Med. 2017 Jul/Aug;79(6):719-727. doi: 10.1097/PSY.0000000000000474.