RecruitingNot ApplicableNCT06028334

GetUp&Go: A Randomized Controlled Trial of an Intervention to Enhance Physical Activity After TBI

GetUp&Go: A Randomized Controlled Trial of a Theory-Based Intervention to Enhance Physical Activity in Chronic, Moderate-Severe Traumatic Brain Injury

Sponsor

Albert Einstein Healthcare Network

Enrollment

70 participants

Start Date

Dec 19, 2023

Study Type

INTERVENTIONAL

Conditions

Traumatic Brain Injury

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 is a remotely delivered 10-week program that includes one-on-one sessions with a therapist and a mobile health application (RehaBot). The main question is whether participants in the 10-week GetUp\&Go program increase their physical activity, and exhibit associated benefits in mental and physical health, relative to those who are put on a waitlist. * Question 1: Do participants who receive immediate treatment with GetUp\&Go show more increased physical activity, measured by accelerometer activity counts per day, and improve more on secondary outcomes, such as self-reported physical activity, emotional function, fatigue, sleep, pain, and health-related quality of life, compared to their baseline, relative to those who are put on a waitlist? * Question 2: Do participants who have continued access to the mobile health component of the intervention, RehaBot, show better maintenance of physical activity gains compared to those who no longer have access to RehaBot? * Question 3: Are individual participant characteristics associated with participants' response to the treatment program?

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria7

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

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Interventions

BEHAVIORALGetUp&Go

A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.

BEHAVIORALGetUp&Go with 10-Week Delay

No assigned treatment during the waitlist phase. Participants in the WL group will be offered the GetUp\&Go intervention, which combines personalized activity planning and a mobile health application, after collection of the primary outcome measure.