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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Start date changed from estimate of Dec 2023 to Dec 19, 2023v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 18, 2023 to Dec 2023
    • Site details revised
    v3
  4. Secondary endpoints: 21 to 27v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT06028334
Lead Sponsor Albert Einstein Healthcare Network
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions
(from sponsor)		 Traumatic Brain Injury
Related terms Brain Injuries, Traumatic, Motor Activity
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov