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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Treatment | Experimental | 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. |
|
| Waitlist | Placebo Comparator | A 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp&Go program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GetUp&Go | Behavioral | A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percent (%) time sedentary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Rabinowitz, PhD | Contact | 215 663-6526 | amanda.rabinowitz@jefferson.edu | |
| Lauren Krasucki, DPT, MPH | Contact | lauren.krasucki@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amanda Rabinowitz, PhD | Albert Einstein Healthcare Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moss Rehabilitation Research Institute | Recruiting | Elkins Park | Pennsylvania | 19027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41705067 | Derived | Hart T, Vaccaro M, Krasucki L, Chervoneva I, Rabinowitz A. Increasing physical activity in moderate-severe traumatic brain injury: protocol for a two-stage randomized controlled trial of a remote, mHealth-enhanced intervention. Front Rehabil Sci. 2026 Feb 2;7:1656326. doi: 10.3389/fresc.2026.1656326. eCollection 2026. |
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All data collected for this trial will be submitted the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system.
The data submitted to FITBIR will be fully de-identified and contain the Global Unique Identifier (GUID). The investigators will assign GUIDs to cases using the methodology recommended by FITBIR. If it is not possible to assign a GUID to cases, a Pseudo-GUID will be assigned. All variables will be converted to the TBI Common Data Elements (CDEs), to the extent possible; otherwise variables that do not map to the TBI CDEs will be submitted as Unique Data Elements (UDEs).
All data from this trial will be submitted to FITBIR within one year of the completion of the award, per the FITBIR submission schedule for clinical trials.
Projects must be specified for research purposes only (not commercial) with the intention to enhance knowledge for the benefit of human health.
Individuals requesting access must have a medical or scientific degree or position relevant for the request.
Individuals must be affiliated with a research, industry, or non-profit institution/business/organization.
All data access requests must be signed by an individual legally authorized to sign on behalf of the institution/business/organization.
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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This project will use masked outcome assessment, with special precautions taken to prevent inadvertent unmasking. These include a "script" reminding participants not to discuss any of their experiences in the trial. Any instances of inadvertent unmasking will be recorded for later analysis of their influence.
| GetUp&Go with 10-Week Delay | Behavioral | 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. |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Self-reported PA | Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity) | Baseline |
| 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 |
| 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 |
| Emotional function | Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms) | Baseline |
| Emotional function | Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms) | 10 weeks after initial randomization |
| 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 |
| Fatigue | Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue) | Baseline |
| Fatigue | Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue) | 10 weeks after initial randomization |
| Fatigue | Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue) | 10 weeks after completing GetUp&Go intervention |
| Sleep Quality | Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality) | Baseline |
| Sleep Quality | Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality) | 10 weeks after initial randomization |
| Sleep Quality | Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality) | 10 weeks after completing GetUp&Go intervention |
| Subjective pain | Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference) | Baseline |
| Subjective pain | Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference) | 10 weeks after initial randomization |
| Subjective pain | Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference) | 10 weeks after completing GetUp&Go intervention |
| Health-related Quality of Life | Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life) | Baseline |
| 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 |
| 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 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001519 | Behavior |