Clinical trial NCT06028334: GetUp&Go: A Randomized Controlled Trial of an Intervention to Enhance Physical Activity After TBI
Official title: GetUp&Go: A Randomized Controlled Trial of a Theory-Based Intervention to Enhance Physical Activity in Chronic, Moderate-Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: physical activity
mobile health
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2023-09-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a waitlist controlled randomized trial. All participants will receive the GetUp\&Go treatment program. Participants will be randomly assigned with a 50% chance of either receiving immediate treatment (IT) with the 10-week program, or going on a 10-week waitlist, after which they will start the GetUp\&Go program.
Primary purpose: TREATMENT

Brief 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?

Detailed description: The investigators will conduct a Randomized Controlled Trial (RCT) of a novel, remotely delivered physical activity (PA) promotion program, called GetUp\&Go-a name selected by focus group participants with moderate-to-severe traumatic brain injury (msTBI). It will be theoretically based, use objective measurement of PA as a primary outcome, and incorporate varied types and amounts of home- and neighborhood-based PA and ways to reduce sedentary behavior, according to participant preferences. Moreover, using a 2-phase design as described below, the investigators will test a method for enhancing longer-term gains in PA using mobile technology, in addition to gains acquired during the first phase of intervention.

Trial design. Participants will undergo baseline testing (T1) and will then be randomized 1:1 to either immediate treatment in GetUp\&Go (IT) or waitlist (WL) for 10 weeks. After testing for the primary outcome (T2), the waitlist group will receive GetUp\&Go for 10 weeks followed by a T2b evaluation for that group. This phase is called the "A phase", for Acquisition.

Following completion of the GetUp\&Go intervention, all participants-regardless of initial group allocation-will be randomized 1:1 to one of two conditions for an additional 10 weeks, the "Follow-Through" (FT) phase. Half of participants will be randomized to the RehaBot condition (RB), which provides continued use of the chatbot to support individualized PA plans, but with no further therapist contact. Participants in the No RehaBot (No RB) condition will not have access to the chatbot. The final evaluation, T3, will occur after the 10-week Follow-Through phase.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Contraindications to increasing PA as judged by study physician, using an exam based on published screening tools
* Medical or psychiatric instability, including current psychosis or severe uncontrolled substance misuse, as assessed using items from the SCID/MINI/ASSIST, or suicidal ideation with intent or plan, as assessed by the Columbia-Suicide Severity Rating Scale, screening version
* Significant physical or intellectual disability predating the TBI
* Neurodegenerative disorder, e.g., Parkinson's disease
* Insufficiently inactive, i.e., reporting \> 23 weekly moderate/vigorous activity units on the Godin Leisure-Time Exercise Questionnaire
* Planned surgery or other hospitalization during the succeeding 9 months
* Physical or sensory disability (e.g., blindness; severe bimanual incoordination) that prevents use of a smartphone

Primary outcomes:
measure: Average activity counts/minute
timeFrame: Baseline
measure: Average activity counts/minute
timeFrame: 10 weeks after initial randomization
measure: Average activity counts/minute
timeFrame: 10 weeks after completing GetUp&Go intervention
Secondary outcomes:
measure: Percent (%) time sedentary
timeFrame: Baseline
measure: Percent (%) time sedentary
timeFrame: 10 weeks after initial randomization
measure: Percent (%) time sedentary
timeFrame: 10 weeks after completing GetUp&Go intervention
measure: Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
timeFrame: Baseline
measure: Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
timeFrame: 10 weeks after initial randomization
measure: Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
timeFrame: 10 weeks after completing GetUp&Go intervention
measure: Average daily step count
timeFrame: Baseline
measure: Average daily step count
timeFrame: 10 weeks after initial randomization
measure: Average daily step count
timeFrame: 10 weeks after completing GetUp&Go intervention
measure: Self-reported PA
timeFrame: Baseline
measure: Self-reported PA
timeFrame: 10 weeks after initial randomization
measure: Self-reported PA
timeFrame: 10 weeks after completing GetUp&Go intervention
measure: Emotional function
timeFrame: Baseline
measure: Emotional function
timeFrame: 10 weeks after initial randomization
measure: Emotional function
timeFrame: 10 weeks after completing GetUp&Go intervention
measure: Fatigue
timeFrame: Baseline
measure: Fatigue
timeFrame: 10 weeks after initial randomization
measure: Fatigue
timeFrame: 10 weeks after completing GetUp&Go intervention
measure: Sleep Quality
timeFrame: Baseline
measure: Sleep Quality
timeFrame: 10 weeks after initial randomization
measure: Sleep Quality
timeFrame: 10 weeks after completing GetUp&Go intervention
measure: Subjective pain
timeFrame: Baseline
measure: Subjective pain
timeFrame: 10 weeks after initial randomization
measure: Subjective pain
timeFrame: 10 weeks after completing GetUp&Go intervention
measure: Health-related Quality of Life
timeFrame: Baseline
measure: Health-related Quality of Life
timeFrame: 10 weeks after initial randomization
measure: Health-related Quality of Life
timeFrame: 10 weeks after completing GetUp&Go intervention
Other outcomes:
Locations:
city: Elkins Park
country: United States
facility: Moss Rehabilitation Research Institute
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Amanda Rabinowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: