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Increasing physical activity in moderate-severe traumatic brain injury: protocol for a two-stage randomized
Tessa Hart1, Monica Vaccaro1, Lauren Krasucki1
1Jefferson Moss Rehabilitation Research Institute, Elkins Park, PA, United States.
Objective:
Protocol for randomized controlled trial (RCT) examining effects of novel, remotely delivered intervention (called GetUp&Go) to increase physical activity (PA) in chronic, moderate-severe traumatic brain injury (msTBI), including a mobile health (mHealth) component.
Design:
RCT (Clinicaltrials.gov NCT06028334) with 1:1 randomization to 10 weeks of immediate treatment (IT) or waitlist (WL), with primary outcome measured at 10 weeks. A second randomization to 10 weeks of continued mHealth support vs. no treatment will allow for examination of effects of mHealth on maintenance of treatment gains.
Participants:
70 community-dwelling adults ≥6 months post msTBI; medically cleared and physically/ cognitively able to participate; physically inactive (≤23 weekly moderate/ vigorous activity units on Godin Leisure-Time Exercise Questionnaire).
Interventions:
10-week GetUp&Go program: manualized, remotely delivered intervention with ingredients based on theoretical model of behavior change, in which participants set individual goals and programs for increasing PA; mHealth support via chatbot that delivers personalized messages, reminders, and reinforcement to participant phone.
Main Outcome Measures:
Primary outcome is activity count measured by accelerometer worn on wrist for 7 days at all assessment intervals. Secondary outcomes include emotional function, fatigue, sleep, pain, health-related quality of life.
Discussion:
While conclusions await the results of the trial, we consider PA enhancement to be a valuable and under-studied direction for treatment of msTBI. The advantages of the described treatment include strong theoretical and empirical basis for the treatment protocol, which has been designed to help to circumvent difficulties with initiation, persistence, and memory that interfere with the ability to develop healthful habits and routines following msTBI.
