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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Einstein Healthcare Network

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • GetUp&Go
  • GetUp&Go with 10-Week Delay

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Albert Einstein Healthcare Network

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator