Aerobic Exercise for Concussion

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by John Leddy, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

Our primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mechanisms for the effect of exercise rehabilitation on concussion recovery.

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 data supports the effectiveness of aerobic exercise as a treatment for concussion?

Research shows that early controlled aerobic exercise after a concussion is safe and may help reduce the duration of symptoms. It can also improve the psychological state by reducing feelings of isolation from missing activities like school and sports. ^{1 2 3 4 5}

Is aerobic exercise safe for people recovering from a concussion?

Research shows that controlled aerobic exercise is generally safe for people recovering from a concussion. Studies indicate that it does not have adverse effects on recovery and may even help improve psychological well-being and reduce symptom duration. ^{4 6 7 8 9}

How is aerobic exercise different from other treatments for concussion?

Aerobic exercise is unique for concussion treatment because it involves gradually introducing light-to-moderate intensity physical activity after an initial rest period, which is a shift from the traditional recommendation of complete rest. This approach aims to safely improve recovery time without worsening symptoms, unlike other treatments that may not incorporate physical activity. ^{6 7 8 10 11}

Research Team

John Leddy, MD

Principal Investigator

University at Buffalo

Eligibility Criteria

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

I am between 18 and 40 years old.

My injury occurred within the last 9 days.

Exclusion Criteria

I have had a serious brain injury confirmed by a scan or specific symptoms.

History of more than 3 diagnosed concussions

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

Trial Timeline

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

Treatment Details

Interventions

• Aerobic Exercise (Behavioral Intervention)

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.

Participant Groups

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

CSM allocated to this group will complete PRA protocols/ will receive treatment as usual and will receive an exercise program in addition to PRA.

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. They will not be given intervention.

Group III: Concussed Service Members PRA Active Control 1 Intervention

CSM allocated to this group will complete PRA protocols/ will receive treatment as usual.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Dr. Jonathan Slonin

State University of New York at Buffalo

Chief Medical Officer since 2020

MD from University of Miami, MBA from George Washington University

Stacy Knapper

State University of New York at Buffalo

Chief Executive Officer since 2023

BSEE from University of Puerto Rico-Mayagüez, MS in Management from Rensselaer Polytechnic Institute

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+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

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+

Joseph W. St. Geme III

Children's Hospital of Philadelphia

Chief Medical Officer since 2021

MD, PhD, MPH

Madeline Bell

Children's Hospital of Philadelphia

Chief Executive Officer since 2015

BSc in Nursing from Villanova University, MSc in Organizational Dynamics from the University of Pennsylvania

Findings from Research

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 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]

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]

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]

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]

References

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

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

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

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

3. England pubmed.ncbi.nlm.nih.gov

A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. [2021]

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

Early Controlled Exercise and Timing of Treatment Following Concussion: A Critically Appraised Topic. [2021]

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

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

6. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of aerobic exercise following concussion: a narrative review. [2023]

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

Randomized Controlled Trial Evaluating Aerobic Training and Common Sport-Related Concussion Outcomes in Healthy Participants. [2020]

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

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

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

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

10. England pubmed.ncbi.nlm.nih.gov

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

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

Feasibility of Aerobic Exercise in the Subacute Phase of Recovery From Traumatic Brain Injury: A Case Series. [2021]