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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01573546
First received: December 22, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cognitive Impairment, no Dementia (CIND)
Behavioral: Aerobic Exercise
Behavioral: DASH diet
Other: Health education control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lifestyle, CVD Risk, and Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Executive function [ Time Frame: Baseline to the 6 month post-treatment assessment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We also will examine treatment effects on the vascular function measures, including blood pressure.


Secondary Outcome Measures:
  • Change in Visuospatial ability and lexical retrieval [ Time Frame: Baseline to the 6 month post-treatment assessment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We will also assess treatment effects on measures of inflammation, including C-reactive protein and interleukin-6.

  • Functional Capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We will also assess treatment effects on measures fasting glucose

  • Cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will also examine treatment effects on cholesterol, including LDL, HDL, and total cholesterol


Estimated Enrollment: 160
Study Start Date: December 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573546

Contacts
Contact: Patrick J Smith, PhD, MPH 919-681-3006 patrick.j.smith@dm.duke.edu
Contact: Stephanie Mabe, MS 919-668-3555 stephanie.mabe@dm.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Patrick J Smith, PhD    919-681-3006    patrick.j.smith@dm.duke.edu   
Principal Investigator: James A Blumenthal, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: James A Blumenthal, PhD Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01573546     History of Changes
Other Study ID Numbers: Pro00031464
Study First Received: December 22, 2011
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 16, 2014