Status:
COMPLETED
Walking After Traumatic Brain Injury in Older Adults
Lead Sponsor:
Timothy Morris
Collaborating Sponsors:
National Institute on Aging (NIA)
Brandeis University
Conditions:
Traumatic Brain Injury
TBI
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The purpose of this research is to learn if different behavioral interventions can change walking behaviors over 12-weeks, in older adults who have previously suffered a non-penetrating mild or modera...
Detailed Description
Older adults are more affected by cognitive impairments due to TBI as compared to younger adults. In addition, older adults are at a much higher risk for sedentary behavior. To address this, we intend...
Eligibility Criteria
Inclusion
- • Suffered a mild or moderate traumatic brain injury within 3 months to 15 years prior to recruitment.
- \* TBI history will be assessed using the validated OSU TBI history questionnaire (Attachment 1). TBI severity will be defined as loss of consciousness of 0-30 minutes (mild) or \>30 minutes and \<24 hours (moderate). If no loss of consciousness was reported but post-traumatic amnesia was reported, then this is considered a mild TBI.
- If clinical reports from the time of injury are available and Glasgow Coma Scale scores are available, then 13-15 is considered mild and 9-12 moderate. A clinical neurologist will review the de-identified OSU TBI forms for accuracy and confirm TBI severity.
- Men and women of all ethnicities/races and socio-economic status.
- 40-80 years.
- Signed Informed consent.
- Physically fit enough to undergo exercise as screened using the Physical Activity Readiness Questionnaire (PAR-Q) and the cardiovascular section of the Health History \& Demographics Questionnaire. An affirmative response (i.e., \"yes\") to any single item regarding an individual's health status is grounds for the necessary medical clearance before enrollment.
- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive tasks (below 20/20 vision).
- Able to speak, read, and write English.
- Ambulatory without pain or the assistance of walking devices.
- Reliable means of transportation (if participating in Boston).
- No diagnosis of a neurological disease.
- No intracerebral brain bleeds.
- Access to a mobile device, laptop or desktop computer with internet access and Bluetooth.
Exclusion
- Diagnosis of a severe TBI (loss of consciousness \>24 hours, post-traumatic amnesia \> 7 days of a Glasgow Coma Scale of \<9) or the presentation of skull breach.
- Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
- Not fluent in English.
- Undergoing any speech or physical therapy
- Not medically cleared for exercise.
- No history of vasovagal episodes (sudden drops in heart rate, poor perfusion, constant dizziness)
- History of intracerebral brain bleeds or strokes.
- Neurological condition (MS, Parkinson's, Dementia, MCI).
- Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, DVT or other cardiovascular events.
- Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year.
- Regular use of an assisted walking device.
Key Trial Info
Start Date :
April 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2025
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT06222502
Start Date
April 10 2024
End Date
December 12 2025
Last Update
January 7 2026
Active Locations (1)
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1
Northeastern University
Boston, Massachusetts, United States, 02115