Walking After Traumatic Brain Injury in Older Adults

NCT06222502 | Completed

• 2 other identifiers: 18-06-23P30AG048785
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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 moderate TBI. Participants will provide information and be screened for eligibility via phone screening call (verification of age, confirmation that the participant is not currently on any medication that affects the central nervous system, and verification that the subject can participate in exercise, brief TBI history). Baseline testing will take place at the Center for Cognitive and Brain Health and Northeastern University Biomedical Imaging Center, for the baseline magnetic resonance imaging, in the interdisciplinary science and engineering complex on Northeastern University's campus. In person testing will take place over one session. The study period lasts 12 weeks, during which all participants will 1. Receive a weekly phone call with study staff and 2. Wear a wrist-worn Fit Bit tracker. A remote participation option is available for those who cannot travel to Northeastern University.

Conditions

Traumatic Brain Injury; TBI; Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury

Keywords

Brain Injury; TBI; Walking; Exercise

Outcome Measures

Primary Outcomes (1)

• Number of planned walks completed

  12 Weeks

Secondary Outcomes (2)

• Functional connectivity of the anterior mid cingulate cortex, the dorsolateral and medial prefrontal cortex and diffusion metrics of the corpus callosum and association fiber tracts of the temporal and frontal lobes

  12 Weeks

• Number of minutes walking per week and total number of steps per week

  12 Weeks

Study Arms (2)

Planning, Reminders, and Micro-Incentives

EXPERIMENTAL

Other: Planning, Reminders, and Micro-Incentives

Health Education

ACTIVE COMPARATOR

Other: Health Education

Interventions

Health Education OTHER

Participants in this group will receive health education "tips" during weekly phone calls with study staff.

Health Education

Planning, Reminders, and Micro-Incentives OTHER

Participants will schedule planned walks during weekly phone calls with study staff. Participants will receive reminders for planned walks and receive micro-incentives after completion.

Planning, Reminders, and Micro-Incentives

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Timothy Morris: lead
• Brandeis University: collaborator

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Brain Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 24, 2024
• Study Start: April 10, 2024
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)