RECRUITING

Walking After Traumatic Brain Injury in Older Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-10
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06222502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women of all ethnicities/races and socio-economic status.
  2. * 40-80 years.
  3. * Signed Informed consent.
  4. * 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.
  5. * Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive tasks (below 20/20 vision).
  6. * Able to speak, read, and write English.
  7. * Ambulatory without pain or the assistance of walking devices.
  8. * Reliable means of transportation (if participating in Boston).
  9. * No diagnosis of a neurological disease.
  10. * No intracerebral brain bleeds.
  11. * Access to a mobile device, laptop or desktop computer with internet access and Bluetooth.
  1. * 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.
  2. * Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
  3. * Not fluent in English.
  4. * Undergoing any speech or physical therapy
  5. * Not medically cleared for exercise.
  6. * No history of vasovagal episodes (sudden drops in heart rate, poor perfusion, constant dizziness)
  7. * History of intracerebral brain bleeds or strokes.
  8. * Neurological condition (MS, Parkinson's, Dementia, MCI).
  9. * Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, DVT or other cardiovascular events.
  10. * Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year.
  11. * Regular use of an assisted walking device.

Contacts and Locations

Study Contact

Timothy Morris, PhD
CONTACT
3395456067
t.morris@northeastern.edu

Study Locations (Sites)

Northeastern University
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Northeastern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-10
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2024-04-10
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • Brain Injury
  • TBI
  • Walking
  • Exercise

Additional Relevant MeSH Terms

  • Traumatic Brain Injury
  • TBI
  • Mild Traumatic Brain Injury
  • Moderate Traumatic Brain Injury