Walking After Traumatic Brain Injury in Older Adults

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Northeastern University
Send
Updated on 25 January 2024
See if I qualify

Summary

The goal of this study is to test the effect of a planning, reminders, and micro-incentives intervention verses regular health education facts on physical activity participation 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, 2. Wear a wrist-worn FitBit tracker and 3. Record their weekly walking activities.

Description

Traumatic brain injury (TBI) is a global health concern and adults over the age of 65 years account for approximately half of all TBI-related hospital admissions in the United States. 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 to test the effect of planning, reminders, and micro-incentives interventions on walking participation of older adults with a history of mild or moderate TBI. Participants will be randomized to either the planning, reminders, and micro-incentives group or to the health education tips group which are delivered over the phone and available virtually. We will give each participant a Fitbit for the duration of the study, and we will use it to track their walking. Our primary aim is to see if there is a difference in the activity levels between the groups. Our secondary aim is to see if the MRI data we collect shows intra-brain connections correlate with physical activity.

Our study is a 12-week two arm pilot randomized control trial-comparing the intervention group to our control group. In the intervention group, participants will have a weekly phone call with lab staff planning 5 days during each week that they plan on having a 30-minute walk. On the days of the walk, participants will receive either a text or an email, of their choice, reminding them of the planned walk. Participants will earn points for each planned walk completed; these can then be redeemed for a monetary reward at the end of the study.

The health education group will also have a weekly phone call with lab staff in which the lab personnel will check up on how the Fitbit is going and share a weekly health tip.

Following recruitment and informed consent, each participant will come into ISEC for their baseline assessment. During this assessment they will fill out questionnaires on their health history to include: Physical Activity Readiness Questionnaire, Ohio state university TBI Questionnaire, PROMIS global health and NeuroQoL Questionnaires, Mediterranean diet adherence, International Physical Activity Questionnaire, Pittsburgh Sleep Quality Index, GAD-7, PHQ-9, BREQ-3 Physical Exercise Motivation, and the Physical Exercise Self Efficacy Questionnaire. Next, the participant will be asked to complete a battery of cognitive tests including: Digital Trail Making, Hopkins Verbal Learning Test, Letter and Category Fluency Test, and a mini mental status exam. This data will all be recorded via redcap. Next, the participant will undergo an MRI. This will take about an hour and the data will be uploaded to the Northeastern Cluster. Upon completion of the baseline session, each participant will be given a Fitbit and assigned to the health education group or the planning, reminders, and micro-incentives group. Over the next 12 weeks, we will have access to the number of planned walks taken or missed and total number of steps completed. We will also capture the data in a redcap spreadsheet. The spreadsheet's utility is growing with each passing week. The final steps for the participants is their post testing where they will complete the same cognitive tasks as in their baseline assessment.

Details
Condition Traumatic Brain Injury, TBI, Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury
Age 65years - 80years
Treatment Health Education, Planning, Reminders, and Micro-Incentives
Clinical Study IdentifierNCT06222502
SponsorNortheastern University
Last Modified on25 January 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

• Suffered a mild or moderate traumatic brain injury within 2 to 10 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
-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
No diagnosis of a neurological disease
MRI compatible
No brain bleeds
Access to a mobile device, laptop or desktop computer with internet access and
Bluetooth

Exclusion Criteria

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 and/or
presence of known subdural hematoma
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
Not MRI compatible
No history of vasovagal episodes (sudden drops in heart rate, poor perfusion, constant
dizziness)
History of 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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.