Dual-Task Exercise for Concussions

Overseen By Hyunhwa Lee, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Must not be taking: Prescribed medications

Disqualifiers: Active medical disease, Psychiatric disturbance, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a 14-day exercise program delivered through a mobile app to improve thinking and movement in young adults who have experienced a mild traumatic brain injury (mTBI) in the past few years. Participants will use the app to perform daily tasks that combine walking and mental challenges. The goal is to determine if these exercises, known as Brain & Walk Exercise Every Day (BraW-Day), can effectively boost cognition and sensorimotor functions. It suits individuals who have experienced an mTBI in the last three months to two years and can commit to the exercise routine. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery strategies for mTBI.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking your current medications to participate in the trial, as being on prescribed medications is part of the exclusion criteria.

What prior data suggests that this exercise program is safe for individuals with mTBI?

Research has shown that exercises combining physical and mental tasks, like those in the BraW-Day program, are generally safe for individuals with a history of mild traumatic brain injury (mTBI). Studies have found that activities such as walking, included in the BraW-Day program, can improve brain health and aid recovery after a brain injury. These exercises are usually well-tolerated and can reduce the risk of ongoing concussion symptoms.

The BraW-Day program features simple daily exercises using a mobile app. Participants engage in tasks like walking while performing mental exercises, such as subtracting numbers or remembering phrases. People who have tried similar exercise programs have not reported major safety issues or negative effects, suggesting that the BraW-Day program is likely safe for most individuals.

Although specific data on negative effects for this exact program is unavailable, the general safety of these types of exercises in mTBI recovery supports their use. Participants should always consult healthcare professionals before starting the program to ensure it suits their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BraW-Day program for concussions because it introduces a dual-task exercise approach that combines cognitive and physical tasks, which is different from standard treatments like rest and gradual return-to-activity protocols. This program is innovative as it engages both the mind and body simultaneously, potentially speeding up recovery by enhancing brain function and coordination. Delivered through a mobile app, it allows for consistent, daily practice, making rehabilitation more accessible and engaging for patients.

What evidence suggests that the BraW-Day program is effective for concussions?

Research shows that exercise can aid recovery after a concussion. Light physical activity that doesn't worsen symptoms, known as sub-threshold aerobic exercise, can enhance brain function and reduce symptoms in individuals with ongoing post-concussion issues. Some studies found that those who followed a prescribed exercise routine recovered about 4.6 days faster than those who didn't exercise. Starting regular physical activity soon after a concussion correlates with fewer symptoms and quicker recovery. In this trial, participants in the intervention group will engage in the Brain & Walk Exercise Every Day program, which combines thinking tasks with walking, based on these positive findings. This program aims to help young adults recover from mild traumatic brain injuries. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-40 who've had a mild traumatic brain injury (mTBI) in the past 3 months to 2 years. It's open to student athletes, Veterans, and ethnic minorities who understand the study and can do all activities. People with other serious medical conditions, psychiatric issues, substance abuse problems, learning disorders or ADHD are not eligible.

Inclusion Criteria

Understanding the protocol

I can fully participate and complete all parts of the BraW-Day program.

You had a mild traumatic brain injury (mTBI) in the past 3 months to 2 years based on a specific test.

Exclusion Criteria

You have another ongoing medical condition or a history of such conditions.

You have mental health issues, substance abuse problems, learning disorder, or ADHD.

You have any condition that might make it unsafe for you to do the tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 14-day dual-task walking exercise program using the Uplode mobile app

2 weeks

Daily home-based exercises

Post-intervention Assessment

Functional assessments and saliva collection are conducted to evaluate post-intervention effects

1 day

1 visit (in-person)

Follow-up

Participants are monitored for sustained effects of the intervention one month after completion

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Brain & Walk Exercise Every Day (BraW-Day)

Trial Overview The trial tests a mobile app called Uplode that guides users through a virtual dual-task walking exercise program named BraW-Day for two weeks. The goal is to see if it helps improve cognition, sensorimotor functions, and other areas affected by mTBI.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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).

Group II: Wait-list Control Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

Published Research Related to This Trial

Participants with traumatic brain injuries (TBI) exhibited similar movement patterns to neurologically healthy individuals while using an elliptical trainer, indicating that elliptical training can effectively mimic walking for rehabilitation purposes.

However, individuals with TBI showed greater variability in their joint movements compared to the healthy group, suggesting that while elliptical training is a viable alternative to treadmill training, it may require careful monitoring to address this increased variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower extremity kinematics during walking and elliptical training in individuals with and without traumatic brain injury. Buster, T., Burnfield, J., Taylor, AP., et al.[2013]

A systematic review of 24 studies found that individuals with concussion show decreased gait velocity and increased lateral movement when performing dual-task assessments, indicating significant performance deficits during cognitive and physical tasks.

The studies reviewed had poor to moderate quality, and many used overlapping participant data, which limits the reliability of the findings and highlights the need for standardized dual-task testing protocols in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual-Task Assessment Protocols in Concussion Assessment: A Systematic Literature Review. Kleiner, M., Wong, L., Dubé, A., et al.[2019]

Collegiate student-athletes who began light exercise within 2 days of a concussion experienced significantly faster symptom recovery (2.4 days less) and clinical recovery (3.2 days less) compared to those who did not exercise, with a 92% higher probability of symptom recovery.

In contrast, those who started exercising 8 days or more after the concussion were 57% less likely to recover from symptoms and 46% less likely to achieve clinical recovery, taking longer to recover overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Exercise is Associated with Faster Concussion Recovery Among Collegiate Athletes: Findings from the NCAA-DoD CARE Consortium. Lempke, LB., Teel, EF., Lynall, RC., et al.[2023]

The Montreal Virtual Exertion (MOVE) protocol is a safe and feasible graded exertion test for both healthy children and those with subacute concussion, as no adverse events were reported during the study.

Increases in heart rate and perceived exertion were similar between the MOVE protocol and the traditional Buffalo Concussion Treadmill Test, suggesting that MOVE can effectively assess exertion levels without the need for expensive equipment or in-person supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. Teel, E., Alarie, C., Swaine, B., et al.[2023]

In a pilot study of 91 patients with postconcussion syndrome (PCS), those who participated in a progressive exercise rehabilitation program showed a high return to full daily functioning, with 72% overall success, including 77% from the physiologic PCS group.

Only 1 out of 6 patients who declined exercise rehabilitation returned to full functioning, suggesting that engaging in exercise may be crucial for recovery from PCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Return to full functioning after graded exercise assessment and progressive exercise treatment of postconcussion syndrome. Baker, JG., Freitas, MS., Leddy, JJ., et al.[2022]

In a study of 65 adolescent athletes with sport-related concussions, a dynamic supervised exercise challenge (DSEC) was more effective at uncovering concussion symptoms than a basic aerobic supervised exercise challenge (ASEC), with 37% of previously asymptomatic patients developing symptoms during the DSEC.

The findings suggest that incorporating dynamic exercises into concussion assessments can enhance symptom detection, which is crucial for guiding safe return-to-play decisions in young athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom Provocation During Aerobic and Dynamic Supervised Exercise Challenges in Adolescents With Sport-Related Concussion. Popovich, M., Sas, A., Almeida, AA., et al.[2022]

In a study of 32 youth athletes recovering from concussion, those who took more steps per day and exercised more frequently and intensely were able to return to play sooner, with 53% needing more than 28 days for clearance.

Specifically, achieving an average of over 10,251 steps per day, exercising at least 4 times a week, and accumulating over 134 minutes of exercise weekly were identified as optimal levels of physical activity that correlated with faster recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More Physical Activity after Concussion Is Associated with Faster Return to Play among Adolescents. Seehusen, CN., Wilson, JC., Walker, GA., et al.[2021]

Early aerobic exercise prescribed within 10 days of a sport-related concussion (SRC) significantly reduces recovery times, even for adolescents with more severe symptoms, as indicated by a hazard ratio of 0.621.

Adolescents with more than three abnormal oculomotor and vestibular signs had a higher incidence of persistent post-concussive symptoms (38%) when assigned to a placebo-like stretching group, compared to only 21% in the aerobic exercise group, suggesting that aerobic exercise may help mitigate long-term symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents With More Oculomotor and Vestibular Signs of Sport-Related Concussion Benefit from Aerobic Exercise: An Exploratory Analysis. Corrado, C., Willer, BS., McPherson, JI., et al.[2023]

A study of 253 individuals with acute concussions found that starting aerobic exercise sooner after the injury is linked to a quicker return to both sports and school or work.

Specifically, initiating aerobic exercise within 1 day post-injury significantly improved recovery times, with delays of 3 and 7 days leading to much slower recovery rates, highlighting the importance of early exercise in concussion management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Earlier time to aerobic exercise is associated with faster recovery following acute sport concussion. Lawrence, DW., Richards, D., Comper, P., et al.[2019]

A structured aerobic exercise intervention (SAEP) significantly reduced the time to reach asymptomatic status and medical clearance in adolescents and young adults recovering from sport-related concussions, compared to usual care exercise prescriptions (UCEP).

The SAEP group experienced consistently lower symptom severity scores throughout the trial, indicating that this exercise protocol is both safe and effective for early intervention following a concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of early aerobic exercise following sport-related concussion: Progressive percentage of age-predicted maximal heart rate versus usual care. Hutchison, MG., Di Battista, AP., Lawrence, DW., et al.[2023]

Aerobic exercise is increasingly recognized as a beneficial rehabilitation technique for individuals recovering from concussions, as it can help reduce symptoms and improve overall function.

The review highlights that while exercise is promising, the optimal parameters for recovery—such as frequency, duration, and intensity—are still not well defined, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. Howell, DR., Taylor, JA., Tan, CO., et al.[2020]

A brief aerobic exercise intervention improved total symptom scores in healthy participants, indicating some positive effects on concussion-related symptoms after training, with scores decreasing from 5.1 to 1.9 over two sessions.

Despite some improvements in symptoms and cognitive flexibility, the overall changes were small and did not significantly affect clinical concussion assessment tools, suggesting that these tools remain stable regardless of aerobic exercise training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial Evaluating Aerobic Training and Common Sport-Related Concussion Outcomes in Healthy Participants. Teel, EF., Register-Mihalik, JK., Appelbaum, LG., et al.[2020]

Citations

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Exercise is Medicine for Concussion - PMC - PubMed Central Thus, sub-threshold aerobic exercise improved the central physiology of the concussed brain and reduced symptoms in athletes with PPCS. In a different study, we ...

2. bjsm.bmj.com bjsm.bmj.com/content/57/12/762

Rest and exercise early after sport-related concussion In a meta-analysis of seven studies, PA and prescribed exercise improved recovery by a mean of −4.64 days (95% CI −6.69, –2.59). After SRC, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9897009/

The Effectiveness of Physical Therapy Interventions for ... Systematic reviews have shown that exercise post-concussion can improve symptom scores after concussion and that sub-symptomatic aerobic ...

4. huskiecommons.lib.niu.edu huskiecommons.lib.niu.edu/cgi/viewcontent.cgi?article=2481&context=studentengagement-honorscapstones

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5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815228

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Dual-Task Exercise for Mild Traumatic Brain Injury (mTBI) We will conduct a nonblinded randomized trial with a wait-list control design to test the efficacy of a 2-week (14 consecutive days) BraW-Day, which is daily ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9397951/

A Remotely Delivered Progressive Walking Intervention for ... A remotely delivered progressive walking intervention designed for adults with persistent mTBI symptoms and explore its effects on health-related outcomes.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10771390/

Brain changes: aerobic exercise for traumatic brain injury ... Aerobic exercise is a promising intervention for adolescent and adult TBI survivors, regardless of injury severity.

9. liebertpub.com liebertpub.com/doi/10.1177/2689288X251376991

Does Physical Fitness Prior to Traumatic Brain Injury Affect ... These studies have found that early exercise interventions following concussion lead to a lower risk of developing persisting concussion ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT06177509

Effect of Graded Aerobic Exercise in Mild Traumatic Brain ... This Randomized Controlled Trial (RCT) will investigate whether graded aerobic exercise has a positive effect on symptom burden (including exercise intolerance) ...