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| Name | Class |
|---|---|
| University of Nevada, Las Vegas | OTHER |
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This research study examines recovery after a sports-related concussion or mild head injury. Many athletes experience lingering problems with thinking, balance, and mood months after a concussion.
We are testing a new home-based program called BraW-Day™ (Brain & Walk Exercise Every Day). This 14-day program uses a mobile app on your smartphone and combines simple brain exercises (like counting backwards) with walking exercises. The idea is that doing these tasks together may help your brain and body recover more effectively.
What You'll Do:
Potential Benefits:
You may experience improvements in thinking, balance, or mood. Even if you don't benefit directly, your participation will help researchers understand how to better support athletes recovering from concussion.
Who Can Join:
This study is registered at ClinicalTrials.gov and approved by the UNLV Institutional Review Board to protect your safety and rights.
Background and Rationale:
Mild traumatic brain injury (mTBI) and sports-related concussion affect thousands of athletes annually and often result in persistent cognitive, physical, and physiological symptoms that can extend months beyond the initial injury. Current recovery protocols typically focus on single-domain interventions (cognitive training alone or physical rehabilitation alone). Emerging evidence suggests that integrated, dual-task interventions-combining cognitive and physical exercise simultaneously-may enhance neuroplasticity and accelerate functional recovery by engaging multiple neural systems.
Study Rationale:
This feasibility study evaluates a novel mobile dual-task intervention (BraW-Day™) designed specifically for athletes recovering from mTBI/concussion. The intervention combines cognitive challenges with structured walking exercises, administered through a smartphone application for accessibility and adherence. We hypothesize that this integrated approach will improve cognitive function, physical balance, and physiological markers (heart rate variability) while demonstrating feasibility for home-based, technology-enabled delivery.
Intervention Description:
BraW-Day™ is a 14-day home-based mobile app intervention combining:
Each session is 15 minutes and performed daily for 14 consecutive days. The app provides real-time feedback and allows users to pause or adjust intensity as needed.
Study Design:
This is a single-arm feasibility study with pre-post assessment design. Participants complete two in-person study visits (baseline and post-intervention) separated by 14 days of home-based intervention.
Assessments:
Primary Outcomes:
Feasibility metrics including recruitment rate, retention rate (completion of 14-day intervention), adherence to daily exercises, and safety.
Secondary Outcomes:
Changes in cognitive function, symptom severity, balance/gait, heart rate variability, and biomarker expression from baseline to post-intervention. User feedback on intervention acceptability and recommendations for future implementation.
Population:
Athletes aged 18-40 who sustained a sports-related concussion or mild TBI within 3-12 months prior to enrollment. Participants must be able to safely perform light physical activity and have consistent smartphone access.
Study Duration:
2 weeks of active intervention per participant; approximately 6.5-7 hours total time commitment.
Significance:
This study addresses a critical gap in mTBI recovery by evaluating an accessible, scalable intervention that integrates cognitive and physical rehabilitation. If feasible and effective, BraW-Day™ could provide athletes with an evidence-based home-based tool to optimize recovery and reduce persistent post-concussion symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14-Day BraW-Day™ Intervention | Experimental | Participants receive a 14-day home-based mobile dual-task intervention (BraW-Day™) delivered via the Uplode smartphone application. The intervention combines daily 15-minute sessions of heel-to-toe and figure-8 walking with concurrent cognitive tasks (e.g., counting backwards, working memory exercises). Cognitive task difficulty increases on Day 8. Optional guided breathing exercises are available via the app. Participants complete assessments at baseline (Day 0) and post-intervention (Day 15). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-Based Mobile Dual-Task Intervention (BraW-Day™) | Behavioral | Participants engage in a 14-day home-based mobile dual-task intervention using the Uplode smartphone application. Each daily session lasts 15 minutes and combines two concurrent components: (1) Walking exercises-progressive heel-to-toe walking alternating with figure-8 walking patterns; and (2) Cognitive tasks-five-minute brain exercises (e.g., counting backwards, working memory challenges) performed simultaneously with walking. On Day 8, cognitive task difficulty increases to provide progressive challenge. The app delivers daily reminders, tracks completion, and provides real-time feedback. Optional guided breathing exercises (5-10 minutes) are available for relaxation and sleep support. Participants self-pace the exercises and can pause the app if needed. The intervention is designed to engage multiple neural systems (motor and cognitive) simultaneously to enhance neuroplasticity and facilitate recovery from concussion/mild traumatic brain injury. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Acceptability of BraW-Day™ Intervention | Semi-structured interview (max 20 minutes) assessing acceptability, feasibility, usability, and barriers/facilitators for the BraW-Day™ exercise program on the Uplode app. System Usability Scale (0-100 scale; higher scores indicate better acceptability). | Day 15 |
| Change in Cognitive Function | Neuro-QOL Cognitive Function Short Form assessing difficulty with memory, attention, executive function, and processing speed (e.g., tracking time, financial document accuracy, following complex instructions). Raw scores converted to T-scores (mean 50, SD 10); higher scores indicate better cognitive function. | Day 0 & Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Symptoms | Neuro-QOL Depression Short Form assessing depressive symptoms. T-scores (mean 50, SD 10); higher scores indicate worse depressive symptoms. | Day 0 & Day 15 |
| Change in Anxiety Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC | Contact | 702-895-3492 | hyunhwa.lee@unlv.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada, Las Vegas | Las Vegas | Nevada | 89154-3018 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19254600 | Background | Silsupadol P, Shumway-Cook A, Lugade V, van Donkelaar P, Chou LS, Mayr U, Woollacott MH. Effects of single-task versus dual-task training on balance performance in older adults: a double-blind, randomized controlled trial. Arch Phys Med Rehabil. 2009 Mar;90(3):381-7. doi: 10.1016/j.apmr.2008.09.559. | |
| 31036562 | Background |
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De-identified individual participant data underlying results published from this study will be shared, including: baseline demographic and clinical characteristics; cognitive assessments (Neuro-QOL Cognitive Function); psychosocial measures (depression, anxiety, fatigue, sleep disturbance, emotional dyscontrol, stigma, social participation, well-being); sensorimotor outcomes (gait analysis, balance, eye-tracking); heart rate variability; intervention adherence data; and interview feedback on acceptability and feasibility. Data will be de-identified and shared via secure institutional database or upon researcher request under a data use agreement. Requests should be directed to the Principal Investigator (hyunhwa.lee@unlv.edu). Data will be available beginning six months after publication of primary outcomes through study data retention period (6 years).
Individual participant data and supporting information will be available beginning 6 months after publication of primary results and will remain available for 6 years from the date of study completion, consistent with institutional data retention requirements.
De-identified data will be available to qualified researchers upon written request to the Principal Investigator. A Data Use Agreement will be required specifying that data will be used only for approved research purposes, securely stored, and not re-identified or shared with unauthorized parties. Data will be provided via secure transfer within 15 business days of request approval.
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All eligible participants will receive the 14-day BraW-Day™ mobile dual-task intervention. This is a single-arm, pre-post design with assessments at baseline and immediately following the 14-day intervention period. There is no control or comparison group.
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Neuro-QOL Anxiety Short Form assessing anxiety symptoms. T-scores (mean 50, SD 10); higher scores indicate worse anxiety.
| Day 0 & Day 15 |
| Change in Fatigue | Neuro-QOL Fatigue Short Form assessing fatigue severity and impact. T-scores (mean 50, SD 10); higher scores indicate worse fatigue. | Day 0 & Day 15 |
| Change in Sleep Disturbance | Neuro-QOL Sleep Disturbance Short Form assessing sleep quality and disturbance. T-scores (mean 50, SD 10); higher scores indicate worse sleep disturbance. | Day 0 & Day 15 |
| Change in Emotional and Behavioral Dyscontrol | Neuro-QOL Emotional and Behavioral Dyscontrol Short Form assessing emotional regulation and impulsivity. T-scores (mean 50, SD 10); higher scores indicate worse dyscontrol. | Day 0 & Day 15 |
| Change in Ability to Participate in Social Roles and Activities | Neuro-QOL Ability to Participate in Social Roles and Activities Short Form assessing functional limitations in social and occupational roles. T-scores (mean 50, SD 10); higher scores indicate better participation. | Day 0 & Day 15 |
| Change in Positive Affect and Well-Being | Neuro-QOL Positive Affect and Well-Being Short Form assessing psychological well-being and positive emotions. T-scores (mean 50, SD 10); higher scores indicate better well-being. | Day 0 & Day 15 |
| Change in Stigma | Neuro-QOL Stigma Short Form assessing felt and internalized stigma related to neurological condition. T-scores (mean 50, SD 10); higher scores indicate greater stigma. | Day 0 & Day 15 |
| Change in Sensorimotor Function - Balance and Walking | mHealth Walking Balance (mHealth-WB) mobile application assessment of walking features and dynamic balance during gait. | Day 0 & Day 15 |
| Change in Sensorimotor Function - Eye Tracking | EyeLink 1000 Plus System (SR Research) rapid eye movement and oculomotor function assessment. | Day 0 & Day 15 |
| Change in Heart Rate Variability | 8-minute seated rest recording measuring cardiac autonomic nervous system function. Higher HRV indicates better parasympathetic tone and cardiovascular function. | Day 0 & Day 15 |
| Change in Salivary Exosomal microRNA | Saliva samples (1-2 mL) analyzed for exosomal microRNA biomarkers as indicators of neurodegeneration and functional recovery. Samples stored at -70°C for future characterization. | Day 0 & Day 15 |
| McCrea M, Broglio S, McAllister T, Zhou W, Zhao S, Katz B, Kudela M, Harezlak J, Nelson L, Meier T, Marshall SW, Guskiewicz KM; CARE Consortium Investigators. Return to play and risk of repeat concussion in collegiate football players: comparative analysis from the NCAA Concussion Study (1999-2001) and CARE Consortium (2014-2017). Br J Sports Med. 2020 Jan;54(2):102-109. doi: 10.1136/bjsports-2019-100579. Epub 2019 Apr 29. |
| 28399158 | Background | McInnes K, Friesen CL, MacKenzie DE, Westwood DA, Boe SG. Mild Traumatic Brain Injury (mTBI) and chronic cognitive impairment: A scoping review. PLoS One. 2017 Apr 11;12(4):e0174847. doi: 10.1371/journal.pone.0174847. eCollection 2017. |
| 8551320 | Background | King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811. |
| 21749974 | Background | Hamilton CM, Strader LC, Pratt JG, Maiese D, Hendershot T, Kwok RK, Hammond JA, Huggins W, Jackman D, Pan H, Nettles DS, Beaty TH, Farrer LA, Kraft P, Marazita ML, Ordovas JM, Pato CN, Spitz MR, Wagener D, Williams M, Junkins HA, Harlan WR, Ramos EM, Haines J. The PhenX Toolkit: get the most from your measures. Am J Epidemiol. 2011 Aug 1;174(3):253-60. doi: 10.1093/aje/kwr193. Epub 2011 Jul 11. |
| 28148495 | Background | Dobson JL, Yarbrough MB, Perez J, Evans K, Buckley T. Sport-related concussion induces transient cardiovascular autonomic dysfunction. Am J Physiol Regul Integr Comp Physiol. 2017 Apr 1;312(4):R575-R584. doi: 10.1152/ajpregu.00499.2016. Epub 2017 Feb 1. |
| 18025964 | Background | Corrigan JD, Bogner J. Initial reliability and validity of the Ohio State University TBI Identification Method. J Head Trauma Rehabil. 2007 Nov-Dec;22(6):318-29. doi: 10.1097/01.HTR.0000300227.67748.77. |
| 22573626 | Background | Cella D, Lai JS, Nowinski CJ, Victorson D, Peterman A, Miller D, Bethoux F, Heinemann A, Rubin S, Cavazos JE, Reder AT, Sufit R, Simuni T, Holmes GL, Siderowf A, Wojna V, Bode R, McKinney N, Podrabsky T, Wortman K, Choi S, Gershon R, Rothrock N, Moy C. Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology. Neurology. 2012 Jun 5;78(23):1860-7. doi: 10.1212/WNL.0b013e318258f744. Epub 2012 May 9. |
| 34663623 | Background | Brett BL, Kerr ZY, Walton SR, Chandran A, Defreese JD, Mannix R, Echemendia RJ, Meehan WP, Guskiewicz KM, McCrea M. Longitudinal trajectory of depression symptom severity and the influence of concussion history and physical function over a 19-year period among former National Football League (NFL) players: an NFL-LONG Study. J Neurol Neurosurg Psychiatry. 2022 Mar;93(3):272-279. doi: 10.1136/jnnp-2021-326602. Epub 2021 Oct 18. |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
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