Cognitive Function, Exosomal microRNA, Heart Rate Variability (HRV), Mild Traumatic Brain Injury (mTBI), Oculomotor, Saliva, Sports-related Concussion, Walking
Conditions
Keywords
dual-task, mild traumatic brain injury (mTBI), sports-related concussion, BraW-Day
Brief summary
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: * Two in-person visits at UNLV (baseline and after 14 days) for assessments * Daily 15-minute exercises at home using the BraW-Day app * Provide a small saliva sample for biomarker testing * Complete brief questionnaires about your symptoms and health 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: * Ages 18-40 * Had a sports-related concussion or mild head injury within the past 3-12 months * Have a smartphone and can safely do light walking and simple tasks This study is registered at ClinicalTrials.gov and approved by the UNLV Institutional Review Board to protect your safety and rights.
Detailed description
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: * Walking exercises: Progressive heel-to-toe walking and figure-8 walking patterns * Cognitive tasks: Five-minute brain exercises (number counting, working memory tasks) performed concurrently with walking * Optional breathing exercises for relaxation and sleep support * Daily reminders and progression tracking via the Uplode mobile application 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: * Cognitive function: Neuro-QoL cognitive assessment * Lifetime trauma history: PhenX Lifetime Trauma and Victimization History Instrument * Physiological markers: Heart rate variability (HRV) measured via wearable sensors * Physical function: Eye-tracking (EyeLink) for oculomotor control; walking assessment using mobile sensors for movement analysis * Symptom severity: Ohio State University TBI Identification Interview, Rivermead Post-Concussion Symptoms Questionnaire, Neurobehavioral Symptom Inventory * Biological markers: Saliva collection for exosomal microRNA analysis to assess recovery at the molecular level * User experience: Semi-structured interview regarding intervention feasibility, acceptability, and perceived benefits 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.
Interventions
BEHAVIORALHome-Based Mobile Dual-Task Intervention (BraW-Day™)
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.
Sponsors
Hyunhwa Lee
University of Nevada, Las Vegas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 40 years * Self-reported history of sports-related concussion (SRC) or mild traumatic brain injury (mTBI) within the past 3 to 12 months * Meets criteria for mTBI based on a standardized screening method (e.g., Ohio State University TBI Identification Method) * Able to safely participate in light physical activity (e.g., walking) and simple cognitive tasks based on self-report and observational screening by the research team * Able to read and understand English (if applicable for study materials) * Able to provide informed consent * Has access to and is able to use a smartphone or mobile device to complete daily app-based activities
Exclusion criteria
* Age younger than 18 years or older than 40 years * History of moderate or severe traumatic brain injury * Concussion or mTBI occurring less than 3 months or more than 12 months prior to enrollment * Self-reported active medical disease or history of neurological or psychiatric conditions unrelated to concussion * Self-reported other medical conditions that would limit safe participation in light physical activity (e.g., walking or balance tasks) * Currently on prescribed medications that may significantly affect cognitive function, balance, neurological function, or safe participation in light physical activity * Inability to use a smartphone or mobile device required for study participation * Inability to read or understand English (as study materials and the mobile application are currently available only in English)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Acceptability of BraW-Day™ Intervention | Day 15 | 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). |
| Change in Cognitive Function | Day 0 & Day 15 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Symptoms | Day 0 & Day 15 | Neuro-QOL Depression Short Form assessing depressive symptoms. T-scores (mean 50, SD 10); higher scores indicate worse depressive symptoms. |
| Change in Anxiety Symptoms | Day 0 & Day 15 | Neuro-QOL Anxiety Short Form assessing anxiety symptoms. T-scores (mean 50, SD 10); higher scores indicate worse anxiety. |
| Change in Fatigue | Day 0 & Day 15 | Neuro-QOL Fatigue Short Form assessing fatigue severity and impact. T-scores (mean 50, SD 10); higher scores indicate worse fatigue. |
| Change in Sleep Disturbance | Day 0 & Day 15 | Neuro-QOL Sleep Disturbance Short Form assessing sleep quality and disturbance. T-scores (mean 50, SD 10); higher scores indicate worse sleep disturbance. |
| Change in Emotional and Behavioral Dyscontrol | Day 0 & Day 15 | Neuro-QOL Emotional and Behavioral Dyscontrol Short Form assessing emotional regulation and impulsivity. T-scores (mean 50, SD 10); higher scores indicate worse dyscontrol. |
| Change in Ability to Participate in Social Roles and Activities | Day 0 & Day 15 | 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. |
| Change in Positive Affect and Well-Being | Day 0 & Day 15 | 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. |
| Change in Stigma | Day 0 & Day 15 | 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. |
| Change in Sensorimotor Function - Balance and Walking | Day 0 & Day 15 | mHealth Walking Balance (mHealth-WB) mobile application assessment of walking features and dynamic balance during gait. |
| Change in Sensorimotor Function - Eye Tracking | Day 0 & Day 15 | EyeLink 1000 Plus System (SR Research) rapid eye movement and oculomotor function assessment. |
| Change in Heart Rate Variability | Day 0 & Day 15 | 8-minute seated rest recording measuring cardiac autonomic nervous system function. Higher HRV indicates better parasympathetic tone and cardiovascular function. |
| Change in Salivary Exosomal microRNA | Day 0 & Day 15 | 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. |
Countries
United States
Contacts
CONTACTHyunhwa Lee, PhD, MSN, APRN, PMHNP-BC
Outcome results
None listed