Improving Walking in Older Adults After Brain Injury
Planning, Reminders and Micro-incentives to Increase Walking After Traumatic Brain Injury in Older Adults
This study is testing two different ways to help older adults who have had a mild or moderate brain injury walk more by either giving them planning support and reminders or health tips over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Northeastern University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06222502 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of two behavioral interventions on increasing walking activity in older adults who have experienced a mild or moderate traumatic brain injury (TBI). Participants will be randomly assigned to either a group that receives planning, reminders, and micro-incentives or a group that receives health education tips. Over a 12-week period, participants will track their walking using a Fit Bit and receive weekly phone calls from study staff. The study will also investigate whether MRI data correlates with physical activity levels.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 40-80 who have suffered a mild or moderate TBI within the last 3 months to 15 years.
Not a fit: Patients who have not experienced a TBI or those who are unable to participate in physical activity due to severe health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance physical activity levels and overall health in older adults recovering from traumatic brain injuries.
How similar studies have performed: Other studies have shown promising results with behavioral interventions aimed at increasing physical activity in older adults, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * 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 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. * 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.
Where this trial is running
Boston, Massachusetts
- Northeastern University — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Timothy Morris, PhD
- Email: t.morris@northeastern.edu
- Phone: 3395456067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.