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Completed

NCT Number: NCT01573546

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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).

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. Change in Language

    Time frame: 6 months

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

  3. Inflammation

    Time frame: 6 months

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

  4. 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.

  5. Blood Pressure

    Time frame: 6 months

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

  6. 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.

  7. 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.

  8. 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.

  9. Fasting glucose

    Time frame: 6 months

    We will also assess treatment effects on measures fasting glucose

  10. Cholesterol

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Lifestyle, CVD Risk, and Cognitive Impairment

Acronym: ENLIGHTEN

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Apr 9, 2012
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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