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

NCT01573546 | Completed DMC

• 1 other identifier: Pro00031464
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment, no Dementia (CIND)

Outcome Measures

Primary Outcomes (1)

• Change in Executive Function

  Composite executive function measure includes Trail Making Test, Stroop Test, Digit Span, Digit Symbol Substitution Test, Ruff 2 \& 7 Test, and Animal Naming Test

  Baseline to post-treatment assessment at 6 months

Secondary Outcomes (10)

• Change in Memory

  6 months

• Change in Language

  6 months

• Inflammation

  6 months

• Functional Capacity

  6 months

• Blood Pressure

  6 months

Study Arms (4)

Aerobic Exercise

EXPERIMENTAL

Behavioral: Aerobic Exercise

DASH diet

EXPERIMENTAL

Behavioral: DASH diet

Combined aerobic exercise and DASH diet

EXPERIMENTAL

Behavioral: Aerobic Exercise; Behavioral: DASH diet

Health education control

ACTIVE COMPARATOR

Other: Health education control

Interventions

Aerobic Exercise BEHAVIORAL

Participants will exercise for 6 months. In the initial 3-month supervised phase, patients will exercise 3 times a week at a level of 50-75% of their initial peak heart rate reserve (HRR) or at their peak heart rate without symptoms, or ST-segment depression \> 1 mm, as determined at the time of their initial exercise test. Aerobic exercise consists of 10 minutes of warm-up exercises followed by 30 minutes of continuous walking or (stationary) biking. Each exercise session will conclude with a 10 minute period of cool-down exercises. During weeks 13 to 24 (i.e., home maintenance phase), participants will be asked to perform 3 aerobic sessions per week at home at 60-70% HRR.

Aerobic Exercise; Combined aerobic exercise and DASH diet

DASH diet BEHAVIORAL

Participants in the DASH condition only receive instruction in modifying the content of their diet to meet DASH guidelines. Participants will be explicitly asked not to exercise and to focus their attention on what they eat. Participants will have been told (in the initial consent form) that the study is designed to study effects of two interventions (altering diet content and exercise) both of which have been shown to improve health. Participants will also be told that it may be easier or more effective for them if they focus first on learning to alter diet content, and they are free to exercise at the end of the 6-month period. Following an initial 1-day feeding period, participants, along with their study partners, will receive instruction on the DASH diet and feedback on their adherence to the diet in a series of half-hour, weekly small group sessions (3 to 4 participants).

Combined aerobic exercise and DASH diet; DASH diet

Health education control OTHER

The Health Education control group will receive weekly 30-min lectures on relevant, health-related topics but will not receive instruction in the DASH diet nor will exercise be promoted. These participants will be asked to maintain their usual dietary and exercise habits for 6 months until they are re-evaluated. These sessions are designed to provide useful information about medical aspects of CVD, but will not provide instruction in the DASH diet or exercise.

Health education control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• 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.

  PMID: 23000080 BACKGROUND

• 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.

  PMID: 31755550 DERIVED

• 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.

  PMID: 30568005 DERIVED

• 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.

  PMID: 28437380 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise; Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• James A Blumenthal, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: April 9, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

US (1)