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RECRUITING
NCT06028334
NA

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

Sponsor: Albert Einstein Healthcare Network

View on ClinicalTrials.gov

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?

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2023-12-19

Completion Date

2027-08-31

Last Updated

2025-03-20

Healthy Volunteers

No

Interventions

BEHAVIORAL

GetUp&Go

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

BEHAVIORAL

GetUp&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.

Locations (1)

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, United States