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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028334
• Other study ID #: iRISID-2023-1533
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: December 2023
• Source: Albert Einstein Healthcare Network
• Contact: Amanda Rabinowitz, PhD
• Phone: 215 663-6526
• Email: amanda.rabinowitz[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Behavioral:
• GetUp&Go
A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.
• 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

Country	Name	City	State
United States	Moss Rehabilitation Research Institute	Elkins Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average activity counts/minute	Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	Baseline
Primary	Average activity counts/minute	Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	10 weeks after initial randomization
Primary	Average activity counts/minute	Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	10 weeks after completing GetUp&Go intervention
Secondary	Percent (%) time sedentary	Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	Baseline
Secondary	Percent (%) time sedentary	Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	10 weeks after initial randomization
Secondary	Percent (%) time sedentary	Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	10 weeks after completing GetUp&Go intervention
Secondary	Percent (%) time engaged in moderate-vigorous physical activity (MVPA)	Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	Baseline
Secondary	Percent (%) time engaged in moderate-vigorous physical activity (MVPA)	Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	10 weeks after initial randomization
Secondary	Percent (%) time engaged in moderate-vigorous physical activity (MVPA)	Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	10 weeks after completing GetUp&Go intervention
Secondary	Average daily step count	Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	Baseline
Secondary	Average daily step count	Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	10 weeks after initial randomization
Secondary	Average daily step count	Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period	10 weeks after completing GetUp&Go intervention
Secondary	Self-reported PA	Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)	Baseline
Secondary	Self-reported PA	Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)	10 weeks after initial randomization
Secondary	Self-reported PA	Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)	10 weeks after completing GetUp&Go intervention
Secondary	Emotional function	Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)	Baseline
Secondary	Emotional function	Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)	10 weeks after initial randomization
Secondary	Emotional function	Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)	10 weeks after completing GetUp&Go intervention
Secondary	Fatigue	Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)	Baseline
Secondary	Fatigue	Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)	10 weeks after initial randomization
Secondary	Fatigue	Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)	10 weeks after completing GetUp&Go intervention
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)	Baseline
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)	10 weeks after initial randomization
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)	10 weeks after completing GetUp&Go intervention
Secondary	Subjective pain	Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)	Baseline
Secondary	Subjective pain	Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)	10 weeks after initial randomization
Secondary	Subjective pain	Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)	10 weeks after completing GetUp&Go intervention
Secondary	Health-related Quality of Life	Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)	Baseline
Secondary	Health-related Quality of Life	Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)	10 weeks after initial randomization
Secondary	Health-related Quality of Life	Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)	10 weeks after completing GetUp&Go intervention