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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare the effects of acute aerobic exercise at two different intensities on psychological measures, symptomology, and time to symptom free in collegiate student athletes with concussion. The main questions it aims to answer are: * Does prescribed, acute aerobic exercise influence measures of pain related fear, anxiety, depression, symptoms, and recovery time? * Does the intensity of the exercise prescription also influence the aforementioned outcomes? Participants will be randomly assigned into either a light intensity or moderate intensity aerobic exercise (treadmill walking) group. They will initiate the exercise protocol 48 hours following their concussion diagnosis, and complete exercise sessions 5 times per week until they report symptom-free. Researchers will compare the light intensity group to the moderate intensity group to see if intensity of exercise influences psychological measures of pain related fear, anxiety, depression, symptomology, and time to symptom-free.

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 data supports the idea that Exercise for Concussion (also known as: Treadmill Walking) is an effective treatment?

The available research shows that engaging in physical activity, like treadmill walking, can help people recover from a concussion more quickly. One study found that youth athletes who took more steps per day and exercised more frequently and for longer periods each week returned to play faster than those who were less active. Specifically, those who took over 10,251 steps per day and exercised at least four times a week for more than 134 minutes in total had better recovery outcomes. This suggests that exercise can be a beneficial part of concussion recovery. ^{1 2 3 4 5}

What safety data exists for exercise treatment in concussion management?

The MOVE protocol, a virtually administered graded exertion test, was evaluated for safety and feasibility in healthy children and children with subacute concussion. No adverse events were recorded, and all feasibility criteria were met. Heart rate, perceived exertion, and symptom outcomes were similar to the Buffalo Concussion Treadmill Test, indicating safety. Additionally, supervised exercise challenges have been shown to be safe in the early symptomatic period after concussion. Graded aerobic treadmill testing in pediatric sports-related concussion was also evaluated for safety, showing it to be safe and clinically useful. ^{6 7 8 9 10}

Is treadmill walking a promising treatment for concussion?

Yes, treadmill walking is a promising treatment for concussion. Research shows that supervised aerobic exercise, like treadmill walking, can help reduce symptoms and improve recovery after a concussion. Many people who participated in exercise programs returned to their normal activities faster than those who did not. ^{6 7 11 12 13}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

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]

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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

More Physical Activity after Concussion Is Associated with Faster Return to Play among Adolescents. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Do physical interventions improve outcomes following concussion: a systematic review and meta-analysis? [2022]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Earlier time to aerobic exercise is associated with faster recovery following acute sport concussion. [2019]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Symptom Provocation During Aerobic and Dynamic Supervised Exercise Challenges in Adolescents With Sport-Related Concussion. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Fifteen minutes of high intensity running can impair performance on concussion testing; Implications for on-field diagnosis in sport. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Use of Supervised Exercise During Recovery Following Sports-Related Concussion. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Graded aerobic treadmill testing in pediatric sports-related concussion: safety, clinical use, and patient outcomes. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Return to full functioning after graded exercise assessment and progressive exercise treatment of postconcussion syndrome. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Outcomes Following a Vestibular Rehabilitation and Aerobic Training Program to Address Persistent Post-Concussion Symptoms. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Adolescents with Sport-Related Concussion Who Adhere to Aerobic Exercise Prescriptions Recover Faster. [2023]