Aerobic Exercise for Head Injuries

(MONITOR-RHI Trial)

Recruiting 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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.

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.

What data supports the effectiveness of the treatment Aerobic exercise for head injuries?

Research suggests that starting aerobic exercise soon after a concussion can help people recover faster, such as returning to school or work more quickly. It may also help reduce the feeling of being isolated and improve mood, even if it doesn't always shorten the time symptoms last. ^{1 2 3 4 5}

Is aerobic exercise safe for people with head injuries?

Research suggests that aerobic exercise is generally safe for people recovering from concussions, as long as it is done below the point where symptoms worsen. Studies have shown that controlled aerobic exercise does not have negative effects on recovery and may even help improve psychological well-being. ^{3 4 6 7 8}

How does aerobic exercise differ from other treatments for head injuries?

Aerobic exercise is unique for head injuries because it can be safely introduced early in the recovery process and helps reduce symptoms without delaying recovery. Unlike traditional rest-based approaches, aerobic exercise below symptom thresholds can improve recovery times and counteract the negative effects of inactivity. ^{4 6 7 8 9}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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]

References

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

Independent, Community-Based Aerobic Exercise Training for People With Moderate-to-Severe Traumatic Brain Injury. [2023]

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

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

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

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

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

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

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

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

6. 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]

7. Canada pubmed.ncbi.nlm.nih.gov

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

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

Adolescents With More Oculomotor and Vestibular Signs of Sport-Related Concussion Benefit from Aerobic Exercise: An Exploratory Analysis. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Neurologic benefits of sports and exercise. [2019]