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Exercise and Brain Health (EBH)

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ClinicalTrials.gov Identifier: NCT02626442
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Rich Macko, Baltimore VA Medical Center

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.


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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise and Brain Health
Study Start Date : July 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Exercise
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.



Primary Outcome Measures :
  1. Change from Baseline in executive function [ Time Frame: 6 months ]
    Measured by cognitive battery

  2. Change from baseline in cortical thickness [ Time Frame: 6 month ]
    Measured during brain MRI

  3. Change from baseline in EEG [ Time Frame: 6 month ]
    EEG will be performed during tasks

  4. Change from baseline in hippocampal volume [ Time Frame: 6 month ]
    Measured during brain MRI



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

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


Contacts
Contact: Rich Macko, MD 410-605-7000 ext 7063 rmacko@grecc.umaryland.edu
Contact: Charlene Hafer-Macko, MD 410-605-7000 ext 5451 cmacko@grecc.umaryland.edu

Locations
United States, Maryland
Baltimore VA Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Emily Byrne, BS    410-605-7000 ext 4321    emily.byrne@va.gov   
Sponsors and Collaborators
Baltimore VA Medical Center
University of Maryland
Investigators
Study Director: Emily Byrne, BS Baltimore VA Medical Center

Responsible Party: Rich Macko, Associate Director of Research for the GRECC, Baltimore VA Medical Center
ClinicalTrials.gov Identifier: NCT02626442     History of Changes
Other Study ID Numbers: BaltimoreVAMC
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Rich Macko, Baltimore VA Medical Center:
Cognition
Exercise

Additional relevant MeSH terms:
Ischemic Attack, Transient
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases