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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01573546
Recruitment Status : Completed
First Posted : April 9, 2012
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE December 22, 2011
First Posted Date  ICMJE April 9, 2012
Last Update Posted Date April 18, 2018
Study Start Date  ICMJE December 2011
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
  • Change in Executive Function [ Time Frame: Baseline to the 6 month post-treatment assessment ]
    Composite executive function measure includes Digit Symbol, Trail Making Test, Stroop Test, Ruff 2 & 7 Test, Digit Span, Animal Naming.
  • Blood pressure [ Time Frame: 6 months ]
    We also will examine treatment effects on the vascular function measures, including blood pressure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
  • 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)
  • Change in Language [ Time Frame: 6 months ]
    Secondary outcomes will include composite measures of language (Controlled Oral Word Association Test and Animal Naming Test)
  • Inflammation [ Time Frame: 6 months ]
    We will also assess treatment effects on measures of inflammation, including C-reactive protein and interleukin-6.
  • 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.
  • Blood Pressure [ Time Frame: 6 months ]
    We also will examine treatment effects on the vascular function measures, including blood pressure.
  • 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.
  • 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.
  • 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.
  • Fasting glucose [ Time Frame: 6 months ]
    We will also assess treatment effects on measures fasting glucose
  • Cholesterol [ Time Frame: 6 months ]
    We will also examine treatment effects on cholesterol, including LDL, HDL, and total cholesterol
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
  • Change in Visuospatial ability and lexical retrieval [ Time Frame: Baseline to the 6 month post-treatment assessment ]
    Secondary outcomes will include a composite measure of Visuospatial ability (Rey-O), Language/lexical Retrieval (Controlled Oral Word Association Test), and Memory/learning (HVLT-R, Rey-O, immediate & delayed recall).
  • Inflammation [ Time Frame: 6 months ]
    We will also assess treatment effects on measures of inflammation, including C-reactive protein and interleuken-6.
  • 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.
  • 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.
  • 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.
  • 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.
  • Fasting glucose [ Time Frame: 6 months ]
    Fasting glucose
  • Cholesterol [ Time Frame: 6 months ]
    We will also examine treatment effects on cholesterol, including LDL, HDL, and total cholesterol
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ENLIGHTEN: Exercise and NutritionaL Interventions for coGnitive and Cardiovascular HealTh ENhancement
Official Title  ICMJE Lifestyle, CVD Risk, and Cognitive Impairment
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cognitive Impairment, no Dementia (CIND)
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • Experimental: Aerobic Exercise
    Intervention: Behavioral: Aerobic Exercise
  • Experimental: DASH diet
    Intervention: Behavioral: DASH diet
  • Experimental: Combined aerobic exercise and DASH diet
    Interventions:
    • Behavioral: Aerobic Exercise
    • Behavioral: DASH diet
  • Active Comparator: Health education control
    Intervention: Other: Health education control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2012)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01573546
Other Study ID Numbers  ICMJE Pro00031464
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James A Blumenthal, PhD Duke University
PRS Account Duke University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP