Exercise and Brain Health



Status:Recruiting
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - 95
Updated:4/21/2016
Start Date:July 2013
End Date:January 2025
Contact:Rich Macko, MD
Email:rmacko@grecc.umaryland.edu
Phone:410-605-7000

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The risk of stroke and vascular dementia is high in individuals who have had a prior stroke
or TIA, and in those who have vascular disease risk factors, such as high blood pressure,
abnormal cholesterol, diabetes or pre-diabetes. These vascular risk factors can improve with
exercise. This study will examine the impact of a 6 month, low intensity group exercise
class on fitness, walking, balance, and brain health.

This study will also collect fitness, walking, balance, and brain health outcome measures at
baseline and post all other MERCE exercise and robotics interventions.

A major public health problem in aging is that about half of all stroke survivors have
significant cognitive problems, called vascular cognitive impairment, nondementia (VCIND)
and also a 10fold increased risk of going on to develop full dementia. Investigators at
University of Maryland and VA Maryland Exercise and Robotics Center of Excellence (MERCE)
have developed exercise programs for individuals that have suffered a disabling stroke that
improve cardiovascular fitness levels, walking function, balance, and can reverse impaired
glucose tolerance (prediabetic state) and non-insulin dependent diabetes in nearly 60% of
stroke patients. Our most recent randomized studies provide the first evidence that aerobic
exercise (cardiovascular) can improve selected aspects of cognitive function that typically
decline with aging, and can increase indirect measures of blood flow to the brain. All of
these findings provide hope that exercise can improve brain health by reducing recurrent
stroke including silent strokes (9/10 stroke are silent), and improving cognitive function.
Yet, no studies to our knowledge have shown that exercise training can improve these
elements of brain health in individuals that have had a minor stroke, silent strokes, or are
at great risk of stroke due to the presence of cerebrovascular risk factors (e.g.,
hypertension, prediabetes, etc.). Research studies in this pilot clinical demonstration
project are designed to: 1) provide new insights into the potential role for exercise to
improve brain health in aging and after minor stroke or at risk for stroke by using advanced
brain imaging techniques; 2) extend our findings in exercise and brain health to a
population with cerebrovascular disease, including those with less severe neurological
deficits; those with cerebrovascular risk factors, minor strokes, transient ischemic attack
(neurological deficits resolved, but still at high risk for further events), or silent
strokes, which are extremely common and predictive of developing cognitive decline and
dementia. Furthermore, the investigators are dedicated to testing exercise programs that can
reach out to the community. Therefore, the investigators propose to use the same low
intensity exercise class format that the investigators already have implemented safely and
effectively at County Senior Centers in Maryland over the last 4 years for more disabled
stroke patients, toward the training of these minimally disabled or nondisabled older
individuals with silent or minor cerebrovascular disease. The results of this study will lay
the groundwork for community partnering and broader dissemination providing exercise
programs designed to preserve and improve brain health for those at high risk of vascular
disease and cognitive decline in aging. The hypothesis is that a 6 month supervised exercise
class will improve brain function and cognitive function among individuals with
cerebrovascular risk factors, minor stroke, TIA, or silent stroke as indicated by measures
before and after training of 1) written and computer - based cognitive function (memory and
thinking) and mood tests and 2) MRI pictures of the brain to see if blood flow is increased
or damage due to old strokes and aging is reduced by the exercise training.

Individuals with cerebrovascular risk factors (e.g., hypertension, diabetes), minor stroke
(nondisabling stroke in terms of community or home walking capability), TIA (warning
stroke), or silent stroke (seen by brain imaging, but no paralysis or obvious stroke signs
or symptoms) will be entered into a 6 month duration exercise class.

Initial medical and neurological evaluation will be conducted by a credentialed Clinician to
assure that individuals are eligible and that they are medically and neurologically approved
for participation in a low intensity aerobic exercise class. All subjects will have approval
of their primary care provider, documenting their awareness and medical approval for their
patient to enter into a low to moderate exercise intensity class. This is the same medical
clearance that is already Institutional Review Board approved and is in use for the similar
exercise class for stroke and neurologic disability in Howard County Department of Aging
Senior Centers. Before starting the exercise, all subjects will be given a series of
baseline testing: 1) walking and balance tests to characterize their mobility performance
capacity (timed walks, Short Physical Performance Battery, Functional Reach, Berg Balance
Test, modified dynamic gait index, and 4 square stepping, 2) a 12 hour battery of written
and computer based cognitive function and mood tests and questionnaires, and 3) MRI that
lasts about 1 hour that includes pictures of the brain . All of these tests will be repeated
at midpoints (i.e., 3 months) and at the end of the training program (6 months, MRIs are
performed only at baseline and 6 months). The exercise class will consist of supervised
walking as well as bar and chair exercises to address upper and lower extremity function.
The class will occur 3 times per week for 6 months.

Individuals are instructed to perform select parallel exercises at home the remaining days
of the weeks and record activities in a homework logbook.

This protocol is being designed in a modular fashion to collect the same outcomes at
baseline and post all other MERCE exercise and robotics interventions.

Inclusion Criteria:

- Adequate language and neurocognitive function to participate in testing and training
and to give adequate informed consent

- Able to rise from a chair unaided

- Completion of all regular post-stroke physical therapy (if applicable)

- Able to walk 30 feet without human assistance

Exclusion Criteria:

- Clinical history of

- unstable angina

- recent (< 3 months) myocardial infarction or congestive heart failure (NYHA
category II)

- hemodynamically significant valvular dysfunction

- peripheral arterial obstructive disorder with claudication

- major orthopedic, chronic pain, or non-stroke neuromuscular disorders
restricting exercise

- pulmonary or renal failure

- poorly controlled hypertension (>190/110), measured on at least two separate
occasions

- recent hospitalization for severe disease or surgery

- severe or global receptive aphasia which confounds reliable testing and training

- Other medical condition precluding patient participation in this study as per
medical judgment of study team

- Untreated major depression

- Pregnancy

- Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers
per day, by self-report

- Dementia and other major cognitive deficits (based upon clinical evaluation)
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Baltimore, Maryland 21201
Phone: 410-605-7000
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