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Dual-Task Exercise for Mild Traumatic Brain Injury (mTBI)

Primary Purpose

TBI (Traumatic Brain Injury), Brain Concussion, Clinical Trial

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain & Walk Exercise Every Day (BraW-Day)
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for TBI (Traumatic Brain Injury) focused on measuring dual-task exercise, mobile app-guided, home-based, mild traumatic brain injury (mTBI), cognitive function, physical function, psychosocial function, salivary exosomal microRNA

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Nevada, Las Vegas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Wait-list Control

Arm Description

The intervention group will be asked to visit the UNLV study site three times to evaluate baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).

The wait-list control group will be will be asked to visit the UNLV study site four times to evaluate pre-baseline (T0), baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).

Outcomes

Primary Outcome Measures

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.
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
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)
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)
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)
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 7, 2023
Last Updated
September 27, 2023
Sponsor
University of Nevada, Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT06037603
Brief Title
Dual-Task Exercise for Mild Traumatic Brain Injury (mTBI)
Official Title
Home-based and Mobile App-guided Dual-Task Exercise for Cognition and Functional Capacity After Mild Traumatic Brain Injury (mTBI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nevada, Las Vegas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
There is a critical need to develop an effective intervention for a chronic concussion or mild traumatic brain injury (mTBI) that presents persistent post-injury functional declines. Up to 40% of mTBIs cause multifaceted and long-term functional declines, including cognitive declines, psychosocial or sensorimotor problems, which results in $17B medical costs each year. Long-term functional impairments have been reported even 5 to 19 years post-injury, which exacerbate neurodegeneration, such as chronic traumatic encephalopathy or Parkinson's disease. Yet, only a very limited or few studies have investigated a followup screening or intervention for long-term and persistent functional declines, suggesting important deficiencies in long-term care for mTBI. The investigators previously developed a virtual 14-day dual-task walking exercise program and tested its feasibility with Asian and Pacific Islanders (API), including those with 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. The specific aims of the current study are: Aim 1: Examine if the mobile app, home-based BraW-Day program is acceptable to young adults with an mTBI. H1. BraW-Day program will (a) be acceptable to the participants, (b) fit with their daily life, and (c) demonstrate feasible and suitable data collection of the daily participation. Aim 2: Test the efficacy of the BraW-Day program on functions after mTBI. H2. BraW-Day program will improve (a) cognitive (measured by a computerized CNS-VS), (b) psychosocial (by Neuro QoL, a standardized self-report tool for neuro-psychosocial conditions), or (c) sensorimotor functions (by walking movement measuring app, 3D kinematic and kinetic gait analysis, and EyeLink rapid eye movement tracker) in mTBI at post-intervention (T2), compared to wait-list controls. Aim 3: Examine the sustained effect of the BraW-Day program on function after mTBI. H3. Functional levels one month after intervention (T3) will be equivalent to or higher than baseline (T1) and postintervention (T2) levels. Our interdisciplinary team (nursing, athletic training, physical therapy, and computer science) aims to use advances in objective functional assessments to address how these relate to home-based and mobile app-based mTBI recovery, which can contribute to developing effective rehabilitation and mTBI care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury), Brain Concussion, Clinical Trial, Rehabilitation, Cognition, Psychosocial Functioning, Walking, Vision, Ocular, Mobile Application, Saliva, microRNA, Exercise
Keywords
dual-task exercise, mobile app-guided, home-based, mild traumatic brain injury (mTBI), cognitive function, physical function, psychosocial function, salivary exosomal microRNA

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-blinded randomized trial with a wait-list control design
Masking
None (Open Label)
Masking Description
Non-blinded randomized trial with a wait-list control design
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group will be asked to visit the UNLV study site three times to evaluate baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).
Arm Title
Wait-list Control
Arm Type
Active Comparator
Arm Description
The wait-list control group will be will be asked to visit the UNLV study site four times to evaluate pre-baseline (T0), baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).
Intervention Type
Behavioral
Intervention Name(s)
Brain & Walk Exercise Every Day (BraW-Day)
Intervention Description
The Brain & Walk Exercise Every Day (BraW-Day) program comprises 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).
Primary Outcome Measure Information:
Title
Change in cognitive function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
Description
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.
Time Frame
45 days
Title
Change in psychosocial function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
Description
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
Time Frame
45 days
Title
Change in sensorimotor function - vision from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
Description
Rapid eye movement by EyeLink 1000 Plus System (SR Research)
Time Frame
45 days
Title
Change in sensorimotor function - walking from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
Description
Walking features and balance by mobile health application for walking balance (mHealth-WB)
Time Frame
45 days
Title
Change in sensorimotor function - gait from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
Description
3-dimensional kinematic and kinetic gait analysis (lab-based approach)
Time Frame
45 days
Title
Acceptability, feasibility of the BraW-Day program on Uplode app
Description
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.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Change in salivary exosomal microRNA from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
Description
Saliva samples will be collected for future characterization of exosomal microRNAs as potential neurodegenerative biomarkers associated with functional level alterations.
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyunhwa Lee, Ph.D.
Phone
7028953492
Email
hyunhwa.lee@unlv.edu
Facility Information:
Facility Name
University of Nevada, Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154-3018
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyunhwa Lee, Ph.D.
Phone
702-895-3492
Email
hyunhwa.lee@unlv.edu
First Name & Middle Initial & Last Name & Degree
Hyunhwa Lee, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dual-Task Exercise for Mild Traumatic Brain Injury (mTBI)

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