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

April 17, 2018 updated by: Duke University

Lifestyle, CVD Risk, and Cognitive Impairment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aerobic Exercise
Behavioral: Aerobic Exercise
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.
Experimental: DASH diet
Behavioral: DASH diet
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).
Experimental: Combined aerobic exercise and DASH diet
Behavioral: Aerobic Exercise
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.
Behavioral: DASH diet
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).
Active Comparator: Health education control
Other: Health education control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Executive Function
Time Frame: 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
Baseline to post-treatment assessment at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Memory
Time Frame: 6 months
Secondary outcomes will include composite measures of memory (Hopkins Verbal Learning Test-Revised and Medical College of Georgia Complex Figure Test)
6 months
Change in Language
Time Frame: 6 months
Secondary outcomes will include composite measures of language (Controlled Oral Word Association Test and Animal Naming Test)
6 months
Inflammation
Time Frame: 6 months
We will also assess treatment effects on measures of inflammation, including C-reactive protein and interleukin-6.
6 months
Functional Capacity
Time Frame: 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.
6 months
Blood Pressure
Time Frame: 6 months
We also will examine treatment effects on the vascular function measures, including blood pressure.
6 months
Flow-mediated dilation of the brachial artery
Time Frame: 6 months
We also will examine treatment effects on the vascular function measures, including flow-mediated dilation of the brachial artery.
6 months
Arterial Stiffness
Time Frame: 6 months
We also will examine treatment effects on the vascular function measures, including pulse-wave velocity of the femoral artery.
6 months
Intima-medial thickness
Time Frame: 6 months
We also will examine treatment effects on the vascular function measures, including intima-medial thickness of the carotid artery.
6 months
Fasting glucose
Time Frame: 6 months
We will also assess treatment effects on measures fasting glucose
6 months
Cholesterol
Time Frame: 6 months
We will also examine treatment effects on cholesterol, including LDL, HDL, and total cholesterol
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James A Blumenthal, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00031464

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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