Exercise and Brain Health (EBH)
Primary Purpose
Stroke, Cardiovascular Risk Factors, Transient Ischemic Attack (TIA)
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Cognition, Exercise
Eligibility Criteria
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)
Sites / Locations
- Baltimore VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group Exercise Class
Testing
Arm Description
6 month group balance/exercise class, three days a week - up to one hour. Exercise program includes walking around a track, bodyweight/balance exercises, and an obstacle course.
Subjects enrolled in other MERCE exercise and robotics interventions will receive balance/walking tests, MRI with famous name recognition task, and cognitive testing pre and post their intervention.
Outcomes
Primary Outcome Measures
Change from Baseline in executive function
Measured by cognitive battery
Change from baseline in cortical thickness
Measured during brain MRI
Change from baseline in EEG
EEG will be performed during tasks
Change from baseline in hippocampal volume
Measured during brain MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT02626442
First Posted
November 18, 2015
Last Updated
October 28, 2016
Sponsor
Baltimore VA Medical Center
Collaborators
University of Maryland
1. Study Identification
Unique Protocol Identification Number
NCT02626442
Brief Title
Exercise and Brain Health
Acronym
EBH
Official Title
Exercise and Brain Health
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Recruiting
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baltimore VA Medical Center
Collaborators
University of Maryland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular Risk Factors, Transient Ischemic Attack (TIA)
Keywords
Cognition, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Exercise Class
Arm Type
Experimental
Arm Description
6 month group balance/exercise class, three days a week - up to one hour. Exercise program includes walking around a track, bodyweight/balance exercises, and an obstacle course.
Arm Title
Testing
Arm Type
No Intervention
Arm Description
Subjects enrolled in other MERCE exercise and robotics interventions will receive balance/walking tests, MRI with famous name recognition task, and cognitive testing pre and post their intervention.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
6 month group exercise class
Primary Outcome Measure Information:
Title
Change from Baseline in executive function
Description
Measured by cognitive battery
Time Frame
6 months
Title
Change from baseline in cortical thickness
Description
Measured during brain MRI
Time Frame
6 month
Title
Change from baseline in EEG
Description
EEG will be performed during tasks
Time Frame
6 month
Title
Change from baseline in hippocampal volume
Description
Measured during brain MRI
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rich Macko, MD
Phone
410-605-7000
Ext
7063
Email
rmacko@grecc.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Charlene Hafer-Macko, MD
Phone
410-605-7000
Ext
5451
Email
cmacko@grecc.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Byrne, BS
Organizational Affiliation
Baltimore VA Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Byrne, BS
Phone
410-605-7000
Ext
4321
Email
emily.byrne@va.gov
12. IPD Sharing Statement
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Exercise and Brain Health
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