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

Primary Purpose

Cognitive Impairment, no Dementia (CIND)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aerobic Exercise

DASH diet

Health education control

About this trial

This is an interventional treatment trial for Cognitive Impairment, no Dementia (CIND)

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Exercise

DASH diet

Combined aerobic exercise and DASH diet

Health education control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Memory

Secondary outcomes will include composite measures of memory (Hopkins Verbal Learning Test-Revised and Medical College of Georgia Complex Figure Test)

Change in Language

Secondary outcomes will include composite measures of language (Controlled Oral Word Association Test and Animal Naming Test)

Inflammation

We will also assess treatment effects on measures of inflammation, including C-reactive protein and interleukin-6.

Functional Capacity

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.

Blood Pressure

We also will examine treatment effects on the vascular function measures, including blood pressure.

Flow-mediated dilation of the brachial artery

We also will examine treatment effects on the vascular function measures, including flow-mediated dilation of the brachial artery.

Arterial Stiffness

We also will examine treatment effects on the vascular function measures, including pulse-wave velocity of the femoral artery.

Intima-medial thickness

We also will examine treatment effects on the vascular function measures, including intima-medial thickness of the carotid artery.

Fasting glucose

We will also assess treatment effects on measures fasting glucose

Cholesterol

We will also examine treatment effects on cholesterol, including LDL, HDL, and total cholesterol

Full Information

NCT ID

NCT01573546

First Posted

December 22, 2011

Last Updated

April 17, 2018

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT01573546

Brief Title

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

Acronym

ENLIGHTEN

Official Title

Lifestyle, CVD Risk, and Cognitive Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Impairment, no Dementia (CIND)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aerobic Exercise

Arm Type

Experimental

Arm Title

DASH diet

Arm Type

Experimental

Arm Title

Combined aerobic exercise and DASH diet

Arm Type

Experimental

Arm Title

Health education control

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Aerobic Exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

DASH diet

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Health education control

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Executive Function

Description

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

Time Frame

Baseline to post-treatment assessment at 6 months

Secondary Outcome Measure Information:

Title

Change in Memory

Description

Secondary outcomes will include composite measures of memory (Hopkins Verbal Learning Test-Revised and Medical College of Georgia Complex Figure Test)

Time Frame

6 months

Title

Change in Language

Description

Secondary outcomes will include composite measures of language (Controlled Oral Word Association Test and Animal Naming Test)

Time Frame

6 months

Title

Inflammation

Description

We will also assess treatment effects on measures of inflammation, including C-reactive protein and interleukin-6.

Time Frame

6 months

Title

Functional Capacity

Description

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.

Time Frame

6 months

Title

Blood Pressure

Description

We also will examine treatment effects on the vascular function measures, including blood pressure.

Time Frame

6 months

Title

Flow-mediated dilation of the brachial artery

Description

We also will examine treatment effects on the vascular function measures, including flow-mediated dilation of the brachial artery.

Time Frame

6 months

Title

Arterial Stiffness

Description

We also will examine treatment effects on the vascular function measures, including pulse-wave velocity of the femoral artery.

Time Frame

6 months

Title

Intima-medial thickness

Description

We also will examine treatment effects on the vascular function measures, including intima-medial thickness of the carotid artery.

Time Frame

6 months

Title

Fasting glucose

Description

We will also assess treatment effects on measures fasting glucose

Time Frame

6 months

Title

Cholesterol

Description

We will also examine treatment effects on cholesterol, including LDL, HDL, and total cholesterol

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James A Blumenthal, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23000080

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.

Results Reference

background

PubMed Identifier

31755550

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.

Results Reference

derived

PubMed Identifier

30568005

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.

Results Reference

derived

PubMed Identifier

28437380

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.

Results Reference

derived

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

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