Program to boost physical activity after traumatic brain injury
GetUp&Go: A Randomized Controlled Trial of a Theory-Based Intervention to Enhance Physical Activity in Chronic, Moderate-Severe Traumatic Brain Injury
This study is testing a 10-week program that helps people recover from a serious brain injury by boosting their physical activity through therapy sessions and a mobile app.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Albert Einstein Healthcare Network Academic / other |
| Locations | 1 site (Elkins Park, Pennsylvania) |
| Trial ID | NCT06028334 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the GetUp&Go program, designed to enhance physical activity in individuals who are at least six months post moderate-to-severe traumatic brain injury (TBI). The program consists of a 10-week remotely delivered intervention that includes one-on-one sessions with a therapist and the use of a mobile health application called RehaBot. Participants are randomized to either receive immediate treatment or be placed on a waitlist, allowing for comparison of physical activity levels and associated health benefits. The study aims to measure changes in physical activity and improvements in mental and physical health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have sustained a moderate-to-severe traumatic brain injury at least six months prior to enrollment.
Not a fit: Patients with medical or psychiatric instability or contraindications to increasing physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve physical activity levels and overall health for individuals recovering from traumatic brain injury.
How similar studies have performed: Other studies have shown promise in using mobile health interventions to promote physical activity, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Elkins Park, Pennsylvania
- Moss Rehabilitation Research Institute — Elkins Park, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Amanda Rabinowitz, PhD — Albert Einstein Healthcare Network
- Study coordinator: Amanda Rabinowitz, PhD
- Email: amanda.rabinowitz@jefferson.edu
- Phone: 215 663-6526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.