Status:
RECRUITING
GetUp&Go: A Randomized Controlled Trial of an Intervention to Enhance Physical Activity After TBI
Lead Sponsor:
Albert Einstein Healthcare Network
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate GetUp\&Go, a program for promoting increased physical activity in individuals at least 6 months post moderate-to-severe traumatic brain injury. GetUp\&Go...
Detailed Description
The investigators will conduct a Randomized Controlled Trial (RCT) of a novel, remotely delivered physical activity (PA) promotion program, called GetUp\&Go-a name selected by focus group participants...
Eligibility Criteria
Inclusion
- Age ≥18
- TBI (open or closed), sustained at least 6 months prior to enrollment, of at least complicated-mild/moderate severity as evidenced by loss or alteration of consciousness ≥ 30 minutes; and/or post-traumatic amnesia (PTA) ≥ 24 hours, not due to intoxication/sedation and documented prospectively from the injury; and/or positive neuroimaging findings consistent with TBI
- Fully weight bearing on lower limbs and able to walk indoors and outdoors without the assistance of another person
- Cognitively able to participate in treatment as judged by ability to travel independently within the community
- Able to communicate adequately in English for participation in the treatment protocols
- Informed consent given by participant
Exclusion
- Contraindications to increasing PA as judged by study physician, using an exam based on published screening tools
- Medical or psychiatric instability, including current psychosis or severe uncontrolled substance misuse, as assessed using items from the SCID/MINI/ASSIST, or suicidal ideation with intent or plan, as assessed by the Columbia-Suicide Severity Rating Scale, screening version
- Significant physical or intellectual disability predating the TBI
- Neurodegenerative disorder, e.g., Parkinson's disease
- Insufficiently inactive, i.e., reporting \> 23 weekly moderate/vigorous activity units on the Godin Leisure-Time Exercise Questionnaire
- Planned surgery or other hospitalization during the succeeding 9 months
- Physical or sensory disability (e.g., blindness; severe bimanual incoordination) that prevents use of a smartphone
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06028334
Start Date
December 19 2023
End Date
August 31 2027
Last Update
March 20 2025
Active Locations (1)
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1
Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, United States, 19027