Exercise Clinical Trial
Official title:
Home-based and Mobile App-guided Dual-Task Exercise for Cognition and Functional Capacity After Mild Traumatic Brain Injury (mTBI)
The investigators previously developed a virtual 14-day dual-task walking exercise program and tested its feasibility with individuals with mild traumatic brain injury (mTBI) history. The investigators will test the feasibility and efficacy of a mobile app-version (Uplode) of the same 14-day exercise program (Brain & Walk Exercise Every Day [BraW-Day]), on cognition, sensorimotor, and other functions in a group of voluntary young adults with an mTBI between last three months to two years, including student athletes, Veterans, and ethnic minorities.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Male and female adults aged 18-40 years - reporting a recent history of mTBI (3 months - 2 years) based on the Ohio State University TBI Identification Method (OSU TBI-ID) - understanding the protocol, and - capable of participating in the full BraW-Day program and completing assessments Exclusion Criteria: - Those with other active medical disease or such history - psychiatric disturbance, substance abuse, learning disorder, or attention deficit hyperactivity disorder (ADHD) - any impairments that may prevent the participant from completing the tests safely, or - currently on prescribed medications - involved in any type of legal action related to the mTBI |
Country | Name | City | State |
---|---|---|---|
United States | University of Nevada, Las Vegas | Las Vegas | Nevada |
Lead Sponsor | Collaborator |
---|---|
University of Nevada, Las Vegas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cognitive function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) | The CNS-Vital Signs Test is a computerized test of cognitive functioning with good-to-excellent reliabilities (most r's > 0.8) in its different sub-tests. It will measure comprehensive neurocognitive function, including memory, attention psychomotor speed, reaction time, and cognitive flexibility. Higher scores mean better cognitive functioning outcomes. The CNS-Vital Signs Test standard scores and percentile ranks are auto-scored using an algorithm based on a normative data set of 1600+ subjects, ranging from Ages 8 - 90. Standard scores > 110 or percentile scores > 74 indicate high function and high capacity, and standard scores < 70 or percentile scores < 2 indicate deficit and impairment likely. | 45 days | |
Primary | Change in psychosocial function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) | The Quality of Life in Neurological Disorders Item Bank will be used to assess depressive, anxious symptoms, fatigue, sleep disturbances, and other functions that may be affected by chronic mTBI. Each domain measure has undergone rigorous qualitative and psychometric evaluation and refinement through numerous clinical studies, so the measures could provide efficient, precise, valid, and responsive indicators of a person's health status. Higher scores mean better psychosocial functioning outcomes. The Quality of Life in Neurological Disorders Item Bank scores have a mean of 50 and standard deviation (SD) of 10 in a referent population.
Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment Scores 2.0 SD or more worse than the mean = severe symptoms/impairment |
45 days | |
Primary | Change in sensorimotor function - vision from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) | Rapid eye movement by EyeLink 1000 Plus System (SR Research) | 45 days | |
Primary | Change in sensorimotor function - walking from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) | Walking features and balance by mobile health application for walking balance (mHealth-WB) | 45 days | |
Primary | Change in sensorimotor function - gait from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) | 3-dimensional kinematic and kinetic gait analysis (lab-based approach) | 45 days | |
Primary | Acceptability, feasibility of the BraW-Day program on Uplode app | Semi-structured interview (max. 20 mins) based on components of the System Usability Scale focusing on acceptability, feasibility, and barriers and facilitators for the BraW-Day exercise program on the Uplode app. System Usability Scale scores are standardized on a 0-100 scale, Higher scores mean better acceptability of an app, so in this study, the Uplode app. | 15 days | |
Secondary | Change in salivary exosomal microRNA from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) | Saliva samples will be collected for future characterization of exosomal microRNAs as potential neurodegenerative biomarkers associated with functional level alterations. This will be explained as part of the informed consent process. | 45 days |
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