StrokeEBHNCT02626442
Exercise and Brain Health
A study testing Exercise in people with Stroke and Cardiovascular Risk Factors, run by Baltimore VA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cardiovascular Risk Factors, Transient Ischemic Attack (TIA)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Baltimore VA Medical Center
Baltimore, Maryland, 21201
Emily Byrne, BS, 410-605-7000 ext. 4321, emily.byrne@va.gov
About this study
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.
Read the 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.
- Being tested
- Exercise
- Keywords
- Cognition, Exercise
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
6 month group exercise class
| Study group | Role | What they receive |
|---|---|---|
| Group Exercise Class | Experimental | 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. Receives: Other: Exercise |
| Testing | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in executive function
Measured by cognitive battery
Measured: 6 months
Change from baseline in cortical thickness
Measured during brain MRI
Measured: 6 month
Change from baseline in EEG
EEG will be performed during tasks
Measured: 6 month
Change from baseline in hippocampal volume
Measured during brain MRI
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJul 2013
- Primary completionJan 2020 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland
- Responsible party
- Principal investigator, Rich Macko, Baltimore VA Medical Center
- Investigators
- Emily Byrne, BS, Study director, Baltimore VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626442
- Sponsor's protocol ID
- BaltimoreVAMC
- Acronym
- EBH
- Status last verified
- Oct 2016
- First submitted
- 18 Nov 2015
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Brain Health
- ClinicalTrials.gov ID
- NCT02626442
- Acronym / sponsor ID
- EBH / BaltimoreVAMC
- Keywords
- Cognition, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Collaborators
- University of Maryland
- Study start
- Jul 2013
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Exercise Class | Experimental | Other: Exercise6 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. |
| Testing | No intervention | –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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Clinical history of
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise6 month group exercise class | Other | Group Exercise Class |
Primary outcome
Change from Baseline in executive function
Time frame: 6 months
Measured by cognitive battery
Change from baseline in cortical thickness
Time frame: 6 month
Measured during brain MRI
Change from baseline in EEG
Time frame: 6 month
EEG will be performed during tasks
Change from baseline in hippocampal volume
Time frame: 6 month
Measured during brain MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Byrne, BS study director
Baltimore VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Stroke and Cardiovascular Risk Factors, run by Baltimore VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rich Macko, MD (410-605-7000 ext. 7063, rmacko@grecc.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in executive function (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.