Aerobic Exercise for Concussion

Overseen By Christopher Stavisky, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Moderate TBI, Polytrauma, Substance abuse, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a specific aerobic exercise program, called Target Heart Rate Aerobic Exercise, can aid workers in recovering from job-related concussions. The exercise involves activities like walking or jogging while monitoring heart rate to ensure safety. The goal is to determine if this approach, which has benefited athletes with concussions, can also help workers. Individuals who sustained a concussion at work within the last three weeks and are part of a workers' compensation program might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance recovery options for workers with concussions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this exercise program is safe for injured workers with concussion?

Research has shown that light aerobic exercise is generally safe for people recovering from a concussion, as long as it doesn't worsen symptoms. One study found that this approach can speed up recovery from sport-related concussions.

Participants in the study exercised at a heart rate below the level that would trigger symptoms. This type of exercise is manageable and doesn't cause major side effects. In fact, it has been shown to aid quicker recovery.

Overall, current evidence suggests that exercising at a specific heart rate is a safe option for those recovering from a concussion. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Target Heartrate Aerobic Exercise (THRAE) for concussion recovery because it offers a tailored approach to exercise therapy. Unlike standard concussion treatments, which often involve rest and symptom management, THRAE focuses on personalized aerobic exercise based on an individual's heart rate threshold. This method not only aims to safely increase physical activity but also helps in potentially accelerating recovery by gradually improving exertion tolerance. By using continuous heart rate monitoring, THRAE ensures that the exercise intensity is optimized for each participant, making it a promising addition to current concussion management strategies.

What evidence suggests that Target Heartrate Aerobic Exercise might be an effective treatment for concussion?

Research has shown that specific aerobic exercises can help people recover faster from sport-related concussions. In this trial, participants will engage in Target Heartrate Aerobic Exercise (THRAE), which involves exercising at a safe level—where symptoms do not worsen—to speed up recovery. For instance, this exercise has improved blood flow in the brain, aiding in healing. Participants perform this exercise at about 80% of the highest heart rate reached during a treadmill test. Starting this exercise early has shortened recovery time and reduced the risk of other injuries after a concussion. While the focus has been on athletes, this exercise plan might also benefit those with work-related concussions. ^{1 2 3 4 6}

Who Is on the Research Team?

Jacob McPherson

Principal Investigator

SUNY Buffalo

Are You a Good Fit for This Trial?

This trial is for workers aged 18-40 who suffered a concussion at work within the last 3 weeks and are involved with the workers compensation program. It's not specified who can't join, but typically those with other serious health issues or conditions that might interfere with exercise would be excluded.

Inclusion Criteria

Received a concussion at work and are engaged with the workers compensation program

I had a concussion within the last 3 weeks.

Exclusion Criteria

Active substance abuse/dependence

Report of injury mechanism occurring due to physical assault

I have conditions or injuries that stop me from taking part in physical tests or rehab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants complete a demographics form and relevant questionnaires, and perform the Buffalo Concussion Treadmill Test (BCTT)

1 week

1 visit (in-person)

Treatment

Participants perform individualized Target Heartrate Aerobic Exercise (THRAE) at home for 20 minutes, 4-5 days per week, for 6 weeks or until medically cleared

6 weeks

6 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Target Heartrate Aerobic Exercise

Trial Overview

The study is testing an aerobic exercise program designed for sports-related concussions to see if it also helps injured workers recover from work-related concussions. Participants will follow a targeted heart rate exercise regimen.

How Is the Trial Designed?

Group I: Target Heartrate Aerobic Exercise (THRAE) Experimental Treatment 1 Intervention

Participants will be asked to complete the Buffalo Concussion Treadmill Test (BCTT), a safe graded exercise test that is used to identify concussion-related exertion intolerance. Participants will wear a heart rate (HR) monitor for the collection of continuous HR data. The test is stopped when a participant's symptoms increase subjectively by an intensity of 3 points or more from the pre-exercise value on a scale from 0-10, or they report being physically exhausted. Their HR at the time of test termination constitutes the HR threshold (HRt). An individualized THRAE program will be prescribed based on 80% of the HRt on the BCTT. Participants will be given a Polar HR monitor to wear while performing their THRAE prescription, which will be performed at home for 20 minutes, 4-5 days per week, for 6 weeks or until medically cleared from their concussion.

Target Heartrate Aerobic Exercise is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Target Heart Rate Aerobic Exercise for:

• Recovery from concussion
• Symptom management for post-concussion syndrome

Approved in Canada as Sub-symptom Threshold Aerobic Exercise for:

• Recovery from concussion
• Symptom management for post-concussion syndrome

Approved in European Union as Graduated Exercise Therapy for:

• Recovery from concussion
• Symptom management for post-concussion syndrome

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

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]

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 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]

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]

The Fitbit Charge HR demonstrated a strong agreement with EKG measurements for heart rate monitoring during exercise, with an intraclass correlation coefficient of 0.83, indicating it can be a reliable tool for tracking heart rates in a general sense.

Despite a small average underestimation of heart rate by about 6 bpm, the Fitbit Charge HR is considered a practical and cost-effective option for monitoring adherence to exercise programs in postconcussion therapy, especially when more expensive equipment is not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a Self-Monitoring Tool for Use in Exercise Therapy. Powierza, CS., Clark, MD., Hughes, JM., et al.[2022]

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]

Subsymptom threshold aerobic exercise has been shown to improve symptoms in patients with postconcussion syndrome, based on a systematic review of 12 studies, indicating it may be a beneficial treatment option.

The exercise protocols typically involved 20 minutes of activity at 80% of the heart rate that triggered symptoms, performed 5-6 days a week, and no adverse events were reported, suggesting this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Subsymptom Threshold Aerobic Exercise for Persistent Concussion Symptoms in Patients With Postconcussion Syndrome: A Systematic Review. McIntyre, M., Kempenaar, A., Amiri, M., 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]

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