Walking After Traumatic Brain Injury in Older Adults

Traumatic Brain Injury Clinical Trial

Official title:

Planning, Reminders and Micro-incentives to Increase Walking After Traumatic Brain Injury in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222502
• Other study ID #: 18-06-23
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Northeastern University
• Contact: Timothy Morris, PhD
• Phone: 3395456067
• Email: t.morris[@]northeastern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Fit Bit 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 Fit Bit 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 Fit Bit 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 Fit Bit 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.
• 55-80 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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Moderate Traumatic Brain Injury
• TBI
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Planning, Reminders, and Micro-Incentives
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.
• Health Education
Participants in this group will receive health education "tips" during weekly phone calls with study staff.

Locations

Country	Name	City	State
United States	Northeastern University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Northeastern University	Brandeis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of number of minutes walking per week and total number of steps per week		12 Weeks
Primary	Number of planned walks completed		12 Weeks
Secondary	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