Exercise and Brain Health (EBH)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02626442|
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : November 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Cardiovascular Risk Factors Transient Ischemic Attack (TIA)||Other: Exercise||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise and Brain Health|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2025|
Experimental: Group Exercise Class
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.
6 month group exercise class
No Intervention: Testing
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626442
|Contact: Rich Macko, MD||410-605-7000 ext email@example.com|
|Contact: Charlene Hafer-Macko, MD||410-605-7000 ext firstname.lastname@example.org|
|United States, Maryland|
|Baltimore VA Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Emily Byrne, BS 410-605-7000 ext 4321 email@example.com|
|Study Director:||Emily Byrne, BS||Baltimore VA Medical Center|