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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Moss Rehabilitation Research Institute
RECRUITING
Elkins Park
Contact Information
Primary
Amanda Rabinowitz, PhD
amanda.rabinowitz@jefferson.edu
215 663-6526
Backup
Lauren Krasucki, DPT, MPH
lauren.krasucki@jefferson.edu
Time Frame
Start Date: 2023-12-19
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 70
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
Leads: Albert Einstein Healthcare Network

This content was sourced from clinicaltrials.gov