Aerobic Exercise for Concussion

Recruiting at 1 trial location

Overseen By Haley Chizuk, PhD, ATC

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must not be taking: ADHD medication, Mood stabilizers

Disqualifiers: Severe TBI, Orthopedic injury, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether early, personalized aerobic exercise (also known as physical activity, cardiovascular exercise, or fitness training) can speed up recovery from concussions and reduce ongoing symptoms. Researchers examine how exercise affects recovery and use a "March-in-place" test to track progress. Participants include service members who have had a concussion in the last nine days, but not a more severe brain injury, and who can safely exercise.

As an unphased trial, this study allows participants to contribute to groundbreaking research on concussion recovery through exercise.

Will I have to stop taking my current medications?

If you are currently taking medications that affect autonomic function, like ADHD medication or mood stabilizers, you may not be eligible to participate in this trial.

What prior data suggests that aerobic exercise is safe for concussion recovery?

Research shows that aerobic exercise is generally safe for people recovering from concussions. Studies have found that it does not harm recovery related to brain function affecting behavior and thinking. However, some individuals might find it more challenging than others. Importantly, aerobic exercise can reduce the risk of long-lasting concussion symptoms and help adolescents recover faster from mild brain injuries. While some might experience slight discomfort, the benefits of aerobic exercise in aiding recovery are significant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of aerobic exercise for individuals with concussions. Unlike typical treatments that often focus on rest and gradual return to activity, this approach investigates whether structured aerobic exercise can aid recovery. By comparing concussed service members who receive aerobic exercise to those who don't, researchers hope to understand how exercise might improve brain healing and overall recovery speed. This trial could lead to new guidelines that incorporate physical activity in concussion management, offering a fresh perspective on enhancing recovery outcomes.

What evidence suggests that aerobic exercise might be an effective treatment for concussion?

Research has shown that aerobic exercise can aid concussion recovery. For instance, a review of several studies found that aerobic exercise significantly reduced symptoms and sped up recovery in teenagers with mild traumatic brain injuries or sport-related concussions. Another study found that aerobic exercise improved concussion symptoms more effectively than stretching alone. In this trial, some concussed service members will receive an exercise program alongside their usual treatment, while others will not receive the exercise intervention. These findings suggest that adding aerobic exercise to recovery plans might help people recover faster and feel better. While more research is needed to fully understand its benefits, early results are promising. ^{1 4 6 7 8}

Who Is on the Research Team?

John Leddy, MD

Principal Investigator

University at Buffalo

Are You a Good Fit for This Trial?

This trial is for military personnel aged 18-40 who have been diagnosed with a concussion within the past 9 days. Participants must be diagnosed by a clinician using international standards.

Inclusion Criteria

Diagnosed with concussion by an experienced clinician using standard international criteria

My injury occurred within the last 9 days.

Exclusion Criteria

Injury involving loss of consciousness for >30 minutes or post-traumatic amnesia >24 hours

History of more than 3 diagnosed concussions

Active substance abuse/dependence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive early, personalized aerobic exercise treatment in addition to the Department of Defense Progressive Return to Activity protocol

4 weeks

Weekly visits for multi-modal assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on persistent post-concussive symptoms and recovery

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise

Trial Overview

The study tests whether personalized aerobic exercise can help improve recovery from concussion, speed up return to duty (RTD), and reduce long-term symptoms in combat service members.

How Is the Trial Designed?

Group I: Concussed Service Members PRA+Exercise Experimental Treatment 1 Intervention

CSM randomized to aerobic exercise+PRA will receive their individualized aerobic exercise prescription plus written instructions on how to follow the PRA protocol. CSM will start the exercise program the day after the first visit. All participants will be reminded each day by text message to complete their assigned activity (in the case of exercise + PRA participants, to perform their exercise at the prescribed dose \[HR\]) and to report any adverse effects). All participants will also report symptoms once daily in response to a text message to their phone. All participants will wear an activity monitor continuously until clinical recovery or for 4 weeks to measure daily activity and sleep. The activity monitor will also act as an HR monitor and will be worn by participants in the PRA+aerobic exercise group during daily exercise sessions to measure participant adherence to the prescribed exercise dose.

Group II: Healthy Control Service Members Active Control 1 Intervention

Non-concussed, age-matched SM will serve as a healthy control group (HC) for comparing CSM to normal physiology and to control for the effect of time and of aerobic exercise. All HC participants will be provided with an activity monitor (with GPS tracking disabled) to wear 24 hours/day for measurement of daily physical activity and sleep duration over the time between first and final test sessions. The activity monitor also acts as an HR monitor to record the participants' HR during their prescribed exercise bouts. HC will be asked to exercise each day at approximately 70% of their age-predicted maximum heart rate (from the formula 220 minus age x 0.7 = target HR) for 20 minutes to control for the effect of exercise on the physiological tests.

Group III: Concussed Service Members PRA Active Control 1 Intervention

CSM randomized to PRA alone will receive written instructions on how to follow the PRA protocol. All participants will be provided with an activity monitor (with GPS tracking disabled), and we will record daily physical activity and sleep patterns.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Axon Medical Technologies LLC

Industry Sponsor

Trials

1

Recruited

170+

The Geneva Foundation

Collaborator

Trials

39

Recruited

13,700+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Center for Neuroscience and Regenerative Medicine (CNRM)

Collaborator

Trials

24

Recruited

5,000+

Quadrant Biosciences Inc.

Industry Sponsor

Trials

3

Recruited

7,800+

Geneva Foundation

Collaborator

Trials

4

Recruited

9,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

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]

A 3-month community-based aerobic exercise training program showed a trend toward improved cardiorespiratory fitness (CRF) in individuals with traumatic brain injury (TBI), with an 8% increase in VO2peak compared to a 4% decrease in a stretching and toning group, indicating potential efficacy of aerobic exercise for this population.

The study demonstrated that while it is feasible to conduct exercise training in community settings for TBI patients, only 50% of participants adhered to the program, highlighting the need for strategies to improve adherence in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. Ding, K., Tarumi, T., Tomoto, T., et al.[2021]

Recent guidelines recommend a brief period of 24-48 hours of rest after a concussion, followed by the introduction of light-to-moderate aerobic exercise, which is considered safe and does not delay recovery.

Current literature suggests that engaging in aerobic exercise below symptom-exacerbating levels may improve recovery time from concussion, highlighting the need for further research to optimize exercise protocols and explore potential sex differences in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of aerobic exercise following concussion: a narrative review. Cordingley, DM., Cornish, SM.[2023]

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]

An 8-week progressive aerobic exercise program was found to be feasible and well tolerated by five individuals recovering from moderate to severe traumatic brain injury (TBI), indicating that aerobic exercise can be safely integrated into their rehabilitation.

Participants successfully adhered to both the aerobic exercise and cognitive training, although measuring exercise intensity was challenging due to poor correlations between heart rate reserve and perceived effort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Aerobic Exercise in the Subacute Phase of Recovery From Traumatic Brain Injury: A Case Series. Morris, TP., Costa-Miserachs, D., Rodriguez-Rajo, P., et al.[2021]

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]

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 involving 75 amateur athletes (45 females and 30 males), light aerobic exercise after a concussion led to increased reports of balance problems and somatic symptoms for both genders, indicating that some symptoms may temporarily worsen post-exercise.

Women experienced significant reductions in emotional symptoms like irritability and sadness after aerobic exercise, while men did not show significant changes in headache or emotional symptoms, highlighting important sex differences in symptom response post-concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences in self-reported symptoms after aerobic exercise in non-injured athletes: implications for concussion management programmes. Gaetz, MB., Iverson, GL.[2009]

Early controlled aerobic exercise following a concussion is safe and does not adversely affect recovery, based on a review of 5 studies including randomized controlled trials and retrospective studies.

Implementing early aerobic exercise may lead to quicker returns to school and a reduction in symptom duration, suggesting it can positively impact recovery despite not always decreasing symptom intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Controlled Exercise and Timing of Treatment Following Concussion: A Critically Appraised Topic. Hattrup, N., Gray, H., Krumholtz, M., 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]

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