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

Sponsor
University of Nevada, Las Vegas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06037603
Collaborator
(none)
44
1
2
10.5
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brain & Walk Exercise Every Day (BraW-Day)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Non-blinded randomized trial with a wait-list control designNon-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
Primary Purpose:
Supportive Care
Official Title:
Home-based and Mobile App-guided Dual-Task Exercise for Cognition and Functional Capacity After Mild Traumatic Brain Injury (mTBI)
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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).

Behavioral: Brain & Walk Exercise Every Day (BraW-Day)
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).

Active Comparator: Wait-list Control

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).

Behavioral: Brain & Walk Exercise Every Day (BraW-Day)
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).

Outcome Measures

Primary Outcome Measures

  1. Change in cognitive function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) [45 days]

    The CNS-Vital Signs Test (CNS-VS) 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.

  2. Change in psychosocial function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) [45 days]

    The Quality of Life in Neurological Disorders (Neuro-QoL) 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.

  3. Change in sensorimotor function - vision from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) [45 days]

    Rapid eye movement by EyeLink 1000 Plus System (SR Research)

  4. Change in sensorimotor function - walking from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) [45 days]

    Walking features and balance by mobile health application for walking balance (mHealth-WB)

  5. Change in sensorimotor function - gait from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) [45 days]

    3-dimensional kinematic and kinetic gait analysis (lab-based approach)

  6. Acceptability, feasibility of the BraW-Day program on Uplode app [15 days]

    semi-structured interview (max. 20 mins) based on components of the System Usability Scale (SUS) focusing on acceptability, feasibility, and barriers and facilitators for the BraW-Day exercise program on the Uplode app

Secondary Outcome Measures

  1. Change in salivary exosomal microRNA from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention) [45 days]

    Saliva samples will be collected for future characterization of exosomal microRNAs as potential neurodegenerative biomarkers associated with functional level alterations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Nevada, Las Vegas Las Vegas Nevada United States 89154-3018

Sponsors and Collaborators

  • University of Nevada, Las Vegas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Nevada, Las Vegas
ClinicalTrials.gov Identifier:
NCT06037603
Other Study ID Numbers:
  • UNLV-2023-245
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Nevada, Las Vegas
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2023