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

Part of paid clinical trials in Elkins Park, Pennsylvania.

Sponsor
Albert Einstein Healthcare Network
Study ID
NCT06028334
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GetUp&Go — BEHAVIORAL
    A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.
  • GetUp&Go with 10-Week Delay — BEHAVIORAL
    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.

Study Details

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?

Key Dates

Start date
Dec 19, 2023
Status verified
Feb 2025
Primary completion
Apr 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate Treatment
    The 10-week GetUp\&Go intervention will be delivered entirely remotely, with 2 weekly sessions with a therapist delivered over videoconference (Zoom for Healthcare) followed by 3 sessions in weeks 3, 5, and 8, over Zoom or phone according to participant preference. The overall goal of the intervention is to develop and support a personalized plan to increase physical activity and decrease sedentary behavior, in concert with the unique capabilities, opportunities, and motivational factors of each participant. In session 2 and thereafter, RehaBot will be supplied to participants to deliver therapeutic ingredients to supplement those provided by the therapist.
  • Placebo Comparator: Waitlist
    A 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp\&Go program.

Primary Outcome Measure

Average activity counts/minute [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moss Rehabilitation Research InstituteElkins ParkPennsylvania19027
Amanda Rabinowitz, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Moss Rehabilitation Research Institute· Elkins Park, PA

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