Exercise for Concussion

Overseen By Daniel Rosenblum, M.Ed.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Structural abnormality, Traumatic brain injury, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 days (median)

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how varying levels of treadmill walking can aid college athletes in recovering from concussions. It seeks to determine whether light or moderate exercise influences pain-related fear, anxiety, depression, and the duration to become symptom-free after a concussion. Participants will join either a light or moderate intensity exercise group to assess which is more effective. The trial seeks varsity college athletes still experiencing concussion symptoms. As an unphased trial, it provides athletes the chance to contribute to understanding effective concussion recovery strategies.

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this exercise protocol is safe for individuals with concussion?

Research has shown that aerobic exercise, such as walking on a treadmill, is generally safe and well-tolerated for people recovering from concussions. One study found that gradually increasing treadmill exercise is safe and provides useful information for doctors. Another study found that light aerobic exercise does not worsen symptoms and can be safely started soon after a concussion.

Overall, these findings suggest that both light and moderate treadmill walking are unlikely to cause harm and could be beneficial. Participants in previous studies did not report significant negative effects, indicating the exercise was well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using treadmill walking as a treatment for concussions because it offers a non-invasive, drug-free option that focuses on controlled physical activity. Unlike traditional treatments that often rely on rest and symptom management, this approach uses specific exercise intensities to potentially speed up recovery. By varying the intensity from light to moderate, it aims to find the optimal level of activity that can help the brain heal more effectively. This method could provide a more active role in recovery, promoting both physical and cognitive benefits without the side effects associated with medication.

What evidence suggests that this exercise protocol is effective for concussion recovery?

Research has shown that physical exercise can aid in recovering from a concussion. In this trial, participants will engage in treadmill walking at different intensities. Studies have found that moderate treadmill exercise reduces brain swelling and improves brain function. Starting physical activity early can lead to fewer symptoms two weeks after a concussion and a faster recovery. Exercise also improves mood and reduces issues like headaches and dizziness, which are part of post-concussion syndrome. These findings suggest that controlled exercise might speed up recovery for those with concussions. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for varsity collegiate athletes who have been diagnosed with a concussion and are still experiencing symptoms at the time they start the exercise program. Athletes will be excluded if they do not meet these criteria.

Inclusion Criteria

I am a varsity athlete in college.

I feel symptoms when I start exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in prescribed aerobic exercise at either light or moderate intensity, 5 times per week until symptom-free

6 days (median)

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of fear, anxiety, depression, and symptomology

5 days after symptom-free (median)

What Are the Treatments Tested in This Trial?

Interventions

• Treadmill Walking

Trial Overview The study is testing how prescribed treadmill walking at two different intensities (light vs. moderate) affects pain-related fear, anxiety, depression, symptoms, and recovery time after a concussion.

How Is the Trial Designed?

Group I: Moderate Intensity Experimental Treatment 1 Intervention

Treadmill walking at a rating of perceived exertion (RPE) of 13.

Group II: Light Intensity Experimental Treatment 1 Intervention

Treadmill walking at a rating of perceived exertion (RPE) of 9.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

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]

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]

Adherence to a personalized aerobic exercise prescription within the first week after a sport-related concussion (SRC) is linked to faster recovery, with adherent adolescents recovering in a median of 12 days compared to 21.5 days for non-adherents.

Interestingly, those who adhered to the exercise regimen were more symptomatic and had lower exercise tolerance at the start, indicating that initial exercise intolerance, rather than symptom severity, influences adherence to the exercise program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents with Sport-Related Concussion Who Adhere to Aerobic Exercise Prescriptions Recover Faster. Chizuk, HM., Willer, BS., Cunningham, A., 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 137 participants (84 men and 53 women), those who completed 15 minutes of high-intensity treadmill running showed a higher rate of impaired performance on the King-Devick concussion test compared to a control group, indicating that exercise can negatively affect test results.

The findings suggest that baseline concussion tests should be conducted at rest and after high-intensity exercise to ensure accurate assessments, with a proposed cut-off of more than 3 seconds as a significant change in scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fifteen minutes of high intensity running can impair performance on concussion testing; Implications for on-field diagnosis in sport. Fronzoni, F., Rio, EK., Girdwood, MA., et al.[2022]

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]

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]

Graded aerobic treadmill testing is a safe and well-tolerated method for evaluating pediatric patients with sports-related concussions, with 97.9% of tests providing valuable clinical information and no serious complications reported.

In patients diagnosed with physiological post-concussion disorder, 90.2% showed clinical improvement after tailored submaximal exercise treatment, and 80.5% successfully returned to sports, highlighting the efficacy of this approach in managing concussion recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graded aerobic treadmill testing in pediatric sports-related concussion: safety, clinical use, and patient outcomes. Cordingley, D., Girardin, R., Reimer, K., et al.[2022]

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]

In a study of 14 adults with persistent concussion symptoms, a 6-month supervised home exercise program combining vestibular rehabilitation and aerobic training led to significant improvements in concussion-related symptoms and functional abilities, as measured by various clinical assessments.

Participants showed notable progress in returning to work and engaging in meaningful activities, with statistical significance in measures related to symptom reduction and balance confidence, indicating the effectiveness of this rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes Following a Vestibular Rehabilitation and Aerobic Training Program to Address Persistent Post-Concussion Symptoms. Moore, BM., Adams, JT., Barakatt, E.[2018]

Subthreshold aerobic exercise significantly reduces symptom scores in individuals with concussion, but it does not shorten the time to recovery, based on a systematic review of 12 trials.

Individually tailored multimodal interventions, which include cervical, vestibular, and oculomotor therapies, show a moderate effect in improving symptom scores and help concussed individuals with persistent symptoms return to sport more quickly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do physical interventions improve outcomes following concussion: a systematic review and meta-analysis? Reid, SA., Farbenblum, J., McLeod, S.[2022]

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]

A study of 126 patients with acute sport-related concussions showed that supervised exercise (SE) initiated within 16 days of injury was safe, with no serious adverse events reported.

Early SE was linked to a significantly quicker return to sport, with patients returning in an average of 26.5 days compared to 35.1 days for those who did not undergo early SE, suggesting it may help speed up recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Supervised Exercise During Recovery Following Sports-Related Concussion. Popovich, M., Almeida, A., Freeman, J., et al.[2021]

Citations

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

Rest and exercise early after sport-related concussion The data show that it is safe to assess exercise tolerance and to prescribe 'mild symptom exacerbation' aerobic exercise treatment as early ...

9. medicine.buffalo.edu medicine.buffalo.edu/content/dam/www/news/imported/pdf/May11/UBconcussionStudy.pdf

Reliability of a Graded Exercise Test for Assessing Recovery ... Our data show that this provocative treadmill test has a high degree of IRR (95%) among various groups of raters for distinguishing symptom exacerbation in ...