Aerobic Exercise for Concussion Recovery

Overseen By Haley Chizuk, MS, ATC

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must not be taking: ADHD, Depression, Anxiety medications

Disqualifiers: Neurological deficit, Cardiac risk, TBI, others

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

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how certain markers in saliva can indicate recovery from a concussion during exercise. Researchers are testing whether specific proteins and molecules in saliva change as the brain heals and how varying exercise levels affect these changes. Participants will be divided into groups performing either high or low-volume aerobic exercise to assess the impact on recovery. The trial seeks adolescent and adult athletes diagnosed with a concussion within the last 10 days who can exercise safely. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on concussion recovery.

Will I have to stop taking my current medications?

The trial excludes participants who are currently taking medications for ADHD, learning disorders, depression, anxiety, or other medications that can affect heart rate. If you are on these medications, you would not be eligible to participate.

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

Research shows that aerobic exercise, whether in large or small amounts, is generally safe for people recovering from concussions. Studies have found that engaging in more than 150 minutes of aerobic exercise per week can improve sleep and reduce symptoms over time. Less exercise is also safe and can aid in symptom improvement.

For both high and low levels of exercise, starting soon after a concussion is safe as long as symptoms do not worsen. This exercise can help individuals return to normal activities more quickly.

In summary, both high and low amounts of aerobic exercise are well-tolerated by those recovering from concussions. Research supports that they generally help reduce symptoms and enhance recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different levels of aerobic exercise might influence recovery from concussions, which is a fresh approach compared to traditional rest-focused recovery methods. By examining salivary biomarkers, the trial aims to gain insights into how exercise at varying intensities affects healing, potentially offering a more active recovery path. This could lead to personalized treatment plans that optimize recovery times and improve outcomes for those with concussions.

What evidence suggests that this trial's treatments could be effective for concussion recovery?

This trial will compare high-volume aerobic exercise with low-volume aerobic exercise for participants recovering from concussions. Research has shown that aerobic exercise aids concussion recovery. One study found that more exercise led to fewer symptoms after a month. Another study showed that exercise sped up recovery by about 4.64 days on average. Exercising for more than 160 minutes a week proved especially beneficial. Even less exercise helped reduce ongoing symptoms over time. Overall, whether in large or small amounts, aerobic exercise supports faster and better recovery from concussions. ^{1 2 3 6 7}

Who Is on the Research Team?

John Leddy, MD

Principal Investigator

University at Buffalo

Barry Willer, PhD

Principal Investigator

University at Buffalo

Praveen Arany, DDS, PhD

Principal Investigator

University at Buffalo

Mohammad Nadir, MD, PhD

Principal Investigator

University at Buffalo

Are You a Good Fit for This Trial?

Inclusion Criteria

Adolescent and adult athletes (age 13-18) diagnosed with SRC within 10 days of injury

Exclusion Criteria

You have had a serious brain injury in the past, which caused you to have a low score on the Glasgow Coma Scale.

You have signs of a specific brain or nerve problem.

Inability to exercise because of orthopedic or cervical spine injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including the Buffalo Concussion Physical Exam and saliva collection

1 week

1 visit (in-person)

Treatment

Participants receive individualized exercise prescriptions based on the Buffalo Concussion Treadmill Test results

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for recovery and changes in salivary biomarkers

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High Volume Aerobic Exercise
• Low Volume Aerobic Exercise

How Is the Trial Designed?

Group I: Concussed Participants Group 2 Experimental Treatment 1 Intervention

Low Volume Group

Group II: Concussed Participants Group 1 Experimental Treatment 1 Intervention

High Volume Group

Group III: Healthy controls Group 1 Active Control 1 Intervention

High Volume Group

Group IV: Healthy Controls Group 2 Active Control 1 Intervention

Low Volume Group

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

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

Aerobic interval training (AIT) significantly improved peak oxygen uptake in cardiac patients more than the usual care rehabilitation, with AIT participants showing an increase from 31.6 to 36.2 mL·kg(-1)·min(-1) compared to a smaller increase in the usual care group.

AIT was performed at a higher intensity (87.3% of peak heart rate) compared to the usual care group (78.7% of peak heart rate), suggesting that the increased intensity of AIT contributes to its greater effectiveness in enhancing exercise capacity and overall cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic interval training increases peak oxygen uptake more than usual care exercise training in myocardial infarction patients: a randomized controlled study. Moholdt, T., Aamot, IL., Granøien, I., et al.[2022]

In a study of 28 heart failure patients, both low-volume time-based resistance exercise training (TRE) and aerobic moderate-intensity cycling (AMC) significantly improved exercise capacity and health-related quality of life after 6 weeks, with no differences between the two methods.

TRE required less time and energy expenditure compared to AMC, suggesting it could be a more time-efficient option for encouraging exercise adherence in patients with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Low-Volume Time-Efficient Resistance Training Versus Endurance Training in Patients With Heart Failure. Munch, GW., Rosenmeier, JB., Petersen, M., et al.[2019]

A systematic review of 11 studies involving 156 clinically stable patients with cardiometabolic diseases found that high-intensity interval exercise (HIIE) can lead to adverse responses in about 8% of individuals, indicating a higher risk compared to moderate-intensity exercise.

It is recommended that patients with cardiometabolic diseases who wish to engage in HIIE should be clinically stable, have prior experience with moderate-intensity exercise, and exercise under supervision to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. Levinger, I., Shaw, CS., Stepto, NK., et al.[2022]

High-intensity aerobic exercise training significantly improves peak oxygen consumption in heart failure patients, with a mean increase of 3.33 ml·kg(-1)·min(-1), which is a 23% improvement from baseline, compared to control groups.

No deaths were reported as directly attributable to exercise during the study, indicating that higher exercise intensity can be safely implemented in heart failure rehabilitation without increasing mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and cardiovascular responses to different exercise training intensities in patients with heart failure: a systematic review and meta-analysis. Ismail, H., McFarlane, JR., Nojoumian, AH., et al.[2022]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

In a review of 113 randomized controlled trials involving 5909 participants with knee osteoarthritis, only 44.2% reported adverse events (AEs), indicating potential underreporting of exercise-related harm, which was found in 6.0% of participants with clear AE statements.

The study highlighted improvements in reporting AEs and dropouts (DOs) after the implementation of the CONSORT-2010 guidelines, but emphasized the need for clearer definitions and reporting standards to ensure the safety and efficacy of therapeutic exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Harm in Randomized Controlled Trials of Therapeutic Exercise for Knee Osteoarthritis: A Systematic Review. von Heideken, J., Chowdhry, S., Borg, J., et al.[2023]

This pilot study involving 34 sedentary individuals demonstrated that low-volume high-intensity interval training (HIIT) protocols, performed just 2 times a week for 8 weeks, are feasible and well-tolerated in a community setting, with no adverse events reported.

Both 2×4-minute and 5×1-minute HIIT protocols significantly improved cardiovascular fitness (VO2max) by 20% and 27%, respectively, while requiring 60% less time than traditional moderate-intensity continuous training, highlighting their effectiveness for health promotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of low-volume high-intensity interval training in a community setting: a pilot study. Reljic, D., Wittmann, F., Fischer, JE.[2018]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9231419/

Influence of Aerobic Exercise Volume on Postconcussion ... Greater exercise volume was associated with lower symptom burden after 1 month of study, and an exercise volume > 160 min/wk in the first month of the study was ...

2. 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 ...

3. 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.

4. 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, ...

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

The Influence of Aerobic Exercise Therapy on Patient ... The literature supports that an aerobic exercise intervention improves patient-reported symptoms in patients with persistent post-concussion symptoms (>4 weeks ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11070449/

Exercising More Than 150 Minutes/Week after Concussion ... Our findings indicate an exercise volume of >150 minutes/week led to greater sleep quality improvements compared to those who exercised below this level.

7. mdpi.com mdpi.com/1660-4601/18/14/7373

More Physical Activity after Concussion Is Associated with ... We hypothesized more physical activity, more intense exercise sessions, and higher volumes of exercise would be associated with shorter RTP clearance times.