Aerobic Exercise for Head Injuries

(MONITOR-RHI Trial)

Enrolling by invitation at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Neurological disorders, Eye conditions, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aerobic exercise might aid recovery from repetitive, non-concussive head impacts that affect brain function. Researchers aim to determine if regular aerobic activity can quickly restore normal brain performance. The study includes two groups: one will engage in daily aerobic exercise, while the other will follow a stretching routine. This trial suits collegiate athletes or athlete cadets active in varsity sports who haven't had recent head or neck injuries. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on brain recovery through exercise.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants undergoing active treatment for migraine, depression, anxiety, or ADHD are not excluded, suggesting you may continue these treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that aerobic exercise is generally safe for people recovering from head injuries. Studies have found that starting aerobic exercise soon after a concussion does not cause major issues. In fact, one study found that moderate to vigorous physical activity, such as aerobic exercise, is not only safe but also beneficial. Another study suggested that mild aerobic exercise can be done early on without worsening symptoms.

Overall, research supports that aerobic exercise is well-tolerated and can help reduce symptoms after a head injury. The studies reviewed have reported no significant negative effects from this type of exercise. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using aerobic exercise as a treatment for head injuries because it offers a non-pharmacological approach that may promote brain recovery through increased blood flow and neuroplasticity. Unlike traditional treatments that mainly focus on rest and medication to manage symptoms, aerobic exercise could actively enhance brain healing by stimulating natural repair processes. This approach is particularly promising because it encourages active recovery, potentially reducing recovery time and improving long-term outcomes for those with head injuries.

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

Research has shown that aerobic exercise can aid recovery from head injuries. In this trial, participants in the Intervention Arm will be randomized to either 30 minutes of daily aerobic exercise or 30 minutes of prescribed stretching. Studies have found that structured aerobic exercise after a concussion can alleviate symptoms and improve patient well-being. One review of several studies found that physical activity and prescribed exercise accelerated recovery by about 4.6 days on average. Another study suggested that starting aerobic exercise soon after a concussion leads to better outcomes than resting alone. Overall, aerobic exercise supports a quicker and more effective recovery after head injuries. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals over 18 years old who are collegiate athletes or athlete-cadets in varsity sports. It's not for those with recent significant head injuries, eye conditions affecting blood vessels, neurological/psychiatric disorders that could interfere with the study, or a history of learning disabilities.

Inclusion Criteria

I am an active varsity athlete or athlete-cadet.

Exclusion Criteria

I have an eye condition that affects its blood vessels.

History of any head, neck, or face injury in the 3 months prior to enrollment that precludes participation in contact sports or wearing a mouth guard sensor

History of neurological or psychiatric disorders or neurological disorders that impact electrical activity in the brain (such as seizure disorders), or diagnosed learning disability, that in the opinion of the investigator, would interfere with participation in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Season Assessment

Participants undergo neurologic outcome testing with optical coherence tomography/angiography (OCT/A) and a novel neurologic test battery

Pre-season

1 visit (in-person)

In-Season Monitoring

Participants are monitored for neurologic functioning during the sports season

4 to 7 months

Post-Season Assessment

Participants undergo post-season neurologic outcome testing with OCT/A and a novel neurologic test battery

Post-season

1 visit (in-person)

Intervention

Participants are randomized to 2 weeks of either 30 minutes of daily aerobic exercise or 30 minutes of prescribed stretching

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic exercise

Trial Overview The study is testing how aerobic exercise can help recover normal brain function after repetitive non-concussive head impacts. Participants will be divided into two groups to compare different treatments and monitor their effectiveness.

How Is the Trial Designed?

Group I: Intervention (Exercise or Stretching) Arm Experimental Treatment 1 Intervention

Athletes and athlete cadets will be administered OCT/A and a novel neurologic test battery at pre- and post-season, and 2 weeks after the end of the season. After the end-of-season assessments, participants will be randomized to 2 weeks of either 30 minutes of daily aerobic exercise or to 30-minutes of prescribed stretching.

Group II: Observational (Ad-Lib Exercise) Arm Active Control 1 Intervention

All participants will undergo neurologic outcome testing with optical coherence tomography/angiography (OCT/A) at pre- and post-season and 2 weeks after the end of the season. For two weeks at the end of the sport season, participants will be instructed to refrain from sports involving head contact but to otherwise exercise ad-lib.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8601125/

The Effect of Aerobic Exercise on Concussion Recovery Aerobic exercise does not appear to negatively impact recovery trajectories of neurobehavioral outcomes; however, tolerability may be poorer for patients with ...

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

Optimal Volume of Moderate-to-Vigorous Physical Activity ... Our findings aligned with these studies and suggested that an even higher threshold of 259 minutes of cMVPA within the first week is beneficial.

3. mdpi.com mdpi.com/2227-9059/13/11/2615

The Influence of Aerobic Exercise Therapy on Patient- ... The available literature has found that applying structured aerobic exercise following concussion can improve patient-reported symptom severity compared with ...

4. journals.lww.com journals.lww.com/ajpmr/fulltext/2025/10000/promoting_early_aerobic_exercise_initiation_after.3.aspx

Promoting Early Aerobic Exercise Initiation After Concussion Supervised initiation of aerobic exercise early after concussion appears to be feasible and improve outcomes compared to standard exercise recommendations.

5. 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, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6365060/

Randomized Controlled Trial Evaluating Aerobic Training ... A brief aerobic training protocol had few meaningful effects on clinical concussion assessment in healthy participants.