Exercise Tests for Concussions

Overseen By Sarah Ostop, DPT

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Antidepressants, Anticoagulants, Beta-blockers, Anticonvulsants

Disqualifiers: Neurological disorder, Vestibular disorder, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two exercise tests to assess their effects on symptoms and physical responses in teens recovering from sports-related concussions. One group will perform the Buffalo Concussion Treadmill Test (BCTT), which involves walking on a treadmill with increasing difficulty. The other group will undertake a Modified Dynamic Exertion Test (Dynamic ExIT), which includes treadmill intervals and various physical activities such as jumps and agility drills. Teens aged 14-17 who have experienced a concussion in the last two weeks and can handle structured exercise may be suitable for this study. As an unphased trial, this study provides teens an opportunity to contribute to valuable research that could enhance concussion recovery strategies.

Will I have to stop taking my current medications?

If you are currently taking antidepressant, anticoagulant, beta-blocker, or anticonvulsant medications, you cannot participate in this trial. The protocol does not specify if you need to stop other medications.

What prior data suggests that these exercise tests are safe for adolescents with concussions?

Previous studies have safely used the Buffalo Concussion Treadmill Test (BCTT) to assess how well young athletes with concussions can handle exercise and aid in their recovery. The test reliably identifies when symptoms worsen. However, it is not recommended for those with very severe symptoms (rated 7 out of 10 or higher).

Research has shown that the Modified EXiT Test (mEXiT) is also well-tolerated and provides similar results for both healthy athletes and those recently concussed. This test combines aerobic and dynamic activities to determine readiness to return to sports.

Both tests are generally safe for teenagers recovering from concussions, provided they do not have severe symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to assess and manage concussions through exercise tests. The Buffalo Concussion Treadmill Test (BCTT) is unique because it incrementally increases treadmill incline and speed, allowing a detailed assessment of an individual's tolerance to physical exertion after a concussion. The Modified EXiT Test (mEXiT) stands out by combining treadmill intervals with dynamic exercises like squat jumps and agility drills, offering a more comprehensive evaluation of physical and cognitive recovery. These tests could provide more personalized insights into a patient's recovery process, potentially leading to better-tailored rehabilitation programs.

What evidence suggests that this trial's tests could be effective for concussions?

In this trial, researchers will assign participants to one of two groups to evaluate exercise tolerance after a concussion. Participants in one group will complete the Buffalo Concussion Treadmill Test (BCTT), which effectively assesses exercise capacity following a mild brain injury like a concussion. It identifies exercise intolerance by monitoring symptoms and heart rate changes. Studies have found that a heart rate below 135 beats per minute during the test may indicate a longer recovery time from a concussion.

Participants in the other group will complete the Modified Dynamic Exertion Test (mEXiT), which research supports as a reliable method for assessing physical activity tolerance after a concussion. It helps determine when an athlete can safely return to their sport. This test includes more active movements and has shown that individuals with concussions may perform differently in agility tasks compared to those without. Both tests are valuable for understanding and managing concussion recovery. ^{2 4 6 7 8}

Who Is on the Research Team?

Anthony P Kontos, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adolescents aged 14-17 who have been diagnosed with a sport-related concussion within the last two weeks. They must be referred to exertion therapy by a clinician from UPMC Sports Medicine Concussion Program after certain tests and interviews.

Inclusion Criteria

I was diagnosed with a concussion from sports within the last 2 weeks.

I've been approved for exercise therapy by a UPMC Sports Medicine specialist.

Exclusion Criteria

I lose balance due to dizziness or have fainted from exertion.

More than 2 previous concussions (excluding current injury)

I am currently on medication for depression, blood clots, high blood pressure, or seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Testing

Participants complete either the Buffalo Concussion Treadmill Test (BCTT) or the Modified Dynamic Exertion Test (mEXiT) to assess symptom provocation and physiological response.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BCTT
• Dynamic ExIT

Trial Overview The study compares two types of physical tests: Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT). It looks at how these tests provoke symptoms, affect heart rate, and perceived effort in young athletes post-concussion.

How Is the Trial Designed?

Group I: Modified EXiT Test (mEXiT) Experimental Treatment 1 Intervention

Participants in this group will complete the modified EXiT test (mEXiT). Participants will complete a 12 minute treadmill interval program followed by a dynamic circuit (10 squat jumps, 10 side to side push ups and 10 medicine ball rotations), jump ball toss, zig zag agility and arrow agility. Parameters will be recorded the same as the established dynamic EXiT test; heart rate and RPE will be recorded at 0, 2, 6:30 and 12 minutes of the treadmill program as well as after the second trial of each activity. The time to complete two trials of the zig zag agility and arrow agility will also be recorded.

Group II: Buffalo Concussion Treadmill Test (BCTT) Active Control 1 Intervention

Participants in this group will complete the Buffalo Concussion Treadmill Test (BCTT). This involves individuals walking at 5.8 km/hr. (3.6 mph) at a 0.0% incline (5.1 km/hr. \[3.2 mph\] if below 5' 10" tall), the treadmill incline is increased 1 degree each minute for the first 15 minutes, then speed increased 0.64 km/hr. (0.4 mph) each minute thereafter.

BCTT is already approved in United States, Canada for the following indications:

Approved in United States as Buffalo Concussion Treadmill Test for:

• Assessment of exercise tolerance in patients with concussion
• Identification of heart rate threshold for symptom exacerbation

Approved in Canada as Buffalo Concussion Treadmill Test for:

• Assessment of exercise tolerance in patients with concussion
• Identification of heart rate threshold for symptom exacerbation

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

In a study of 30 participants, including individuals with a history of concussion, performance on neurocognitive tests improved after completing the Buffalo Concussion Treadmill Test (BCTT), indicating that exercise can enhance cognitive function in healthy individuals.

The findings suggest that combining neurocognitive assessments with exercise testing can help clinicians objectively evaluate recovery from concussion, potentially leading to better decisions regarding return-to-play protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Neurocognitive and Exercise Tolerance Testing Improves Objectivity of Buffalo Concussion Treadmill Test. Miner, D., Harper, B.[2023]

The Montreal Virtual Exertion (MOVE) protocol is a safe and feasible graded exertion test for both healthy children and those with subacute concussion, as no adverse events were reported during the study.

Increases in heart rate and perceived exertion were similar between the MOVE protocol and the traditional Buffalo Concussion Treadmill Test, suggesting that MOVE can effectively assess exertion levels without the need for expensive equipment or in-person supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. Teel, E., Alarie, C., Swaine, B., et al.[2023]

In a study of 190 adolescents (103 males and 87 females) with acute sport-related concussions, males exhibited a lower resting heart rate and reached a lower heart rate threshold during the Buffalo Concussion Treadmill Test (BCTT) compared to females, indicating potential sex differences in exercise tolerance post-concussion.

Despite these differences in heart rate metrics, both males and females experienced similar levels of symptom exacerbation and overall performance on the BCTT, suggesting that the test is equally effective for assessing concussion recovery in both sexes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences in the Buffalo Concussion Treadmill Test in adolescents with acute sport-related concussion. Chizuk, HM., Willer, BS., Horn, EC., et al.[2021]

The Buffalo Concussion Treadmill Test (BCTT) is a safe and reliable method for diagnosing physiological dysfunction in individuals with concussion and can differentiate it from other conditions like cervical injury.

The BCTT is also effective in quantifying the severity of concussion symptoms and is used to create a safe aerobic exercise program that can help speed up recovery and facilitate a return to normal activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of graded exercise testing in concussion and return-to-activity management. Leddy, JJ., Willer, B.[2022]

In a study of 73 individuals 4 weeks to 6 months post-mild traumatic brain injury (mTBI), 30% failed the Buffalo Concussion Treadmill Test (BCTT), indicating potential physiological system impairment (PSI) even in those who reported no symptoms.

The mTBI group showed significantly lower test duration and heart rate responses compared to healthy controls, suggesting that the BCTT could be a useful tool for assessing recovery and identifying ongoing issues after mTBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Investigation of Physiological System Impairments in Individuals 4 Weeks to 6 Months Following Mild Traumatic Brain Injury. Galea, O., O'Leary, S., Treleaven, J.[2023]

The Buffalo Concussion Bike Test (BCBT) was developed and found to be comparable to the Buffalo Concussion Treadmill Test (BCTT) in assessing exercise tolerance in adolescents with acute concussion, with similar heart rates at symptom exacerbation.

The BCBT is particularly useful for patients with limited mobility, allowing for effective assessment of concussion recovery without the need for extensive physical movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Buffalo Concussion Bike Test for Concussion Assessment in Adolescents. Haider, MN., Johnson, SL., Mannix, R., et al.[2022]

A new cycling test of exertion showed similar maximum heart rates (HRmax) compared to the Buffalo Concussion Treadmill Test (BCTT) in 19 adults with sport-related concussions, suggesting it could be a valid alternative for assessing exertion post-concussion.

No adverse events were reported during the tests, indicating that both the cycling test and BCTT are safe for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent Validity of a Stationary Cycling Test and the Buffalo Concussion Treadmill Test in Adults With Concussion. Graham, RF., van Rassel, CR., Burma, JS., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06276660

Study Details | NCT06276660 | Post-Concussion ... This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a ...

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2019.00395/full

The Predictive Capacity of the Buffalo Concussion ... A previous study found that an absolute HRt of < 135 bpm was associated with prolonged recovery (>30 days) from sport-related concussion (SRC).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6822206/

The Buffalo Concussion Bike Test for ... Our findings confirm that the HR at symptom exacerbation achieved on the BCBT is equivalent to the BCTT, making it a comparable tool for the assessment of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11323219/

Use of the Buffalo Concussion Treadmill Test in ... The BCTT was developed to measure mTBI-related physiological dysfunction and exercise intolerance in individuals with mild traumatic brain injury (mTBI), ...

5. completeconcussions.com completeconcussions.com/concussion-treatment/how-to-perform-a-buffalo-concussion-treadmill-test/

How to Perform a Buffalo Concussion Treadmill Test The Buffalo Concussion Treadmill Test (BCTT) is a standardized test used to assess an individual's ability to tolerate physical activity after a concussion.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6492460/

The Predictive Capacity of the Buffalo Concussion ... A ΔHR of ≤50 bpm on the BCTT is 73% sensitive and 78% specific for predicting prolonged recovery in concussed adolescents who were prescribed ...

7. medicine.buffalo.edu medicine.buffalo.edu/content/dam/www/news/imported/pdf/May11/UBconcussionStudy.pdf

Reliability of a Graded Exercise Test for Assessing Recovery ... Results: Raters achieved a sensitivity of 99% for identifying actors with symptom exacerbation and a specificity of 89% for ruling out concussion symptoms ...

8. cdn-links.lww.com cdn-links.lww.com/permalink/jsm/a/jsm_2020_01_28_haider_19-313_sdc1.pdf

BUFFALO CONCUSSION TREADMILL TEST (BCTT) The BCTT is not recommended within 24 hours of concussive brain injury or if the patient is too symptomatic (symptom severity 7/10 or more). Safety ...