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

Trial Summary

What is the purpose of this trial?

This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit.

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 data supports the effectiveness of the treatment BCTT, Buffalo Concussion Treadmill Test, for concussions?

The Buffalo Concussion Treadmill Test (BCTT) is shown to be a safe and reliable way to assess exercise tolerance and diagnose physiological issues after a concussion. It helps in creating a safe exercise program to speed up recovery and return to activity, and combining it with neurocognitive tests can improve the accuracy of identifying those needing further care. ^{1 2 3 4 5}

Is the Buffalo Concussion Treadmill Test (BCTT) safe for humans?

The Buffalo Concussion Treadmill Test (BCTT) is considered safe for assessing exercise tolerance in individuals with concussions, as no adverse events were reported in studies involving adolescents and children with subacute concussions. ^{1 2 3 5 6}

How is the BCTT treatment for concussions different from other treatments?

The Buffalo Concussion Treadmill Test (BCTT) is unique because it uses a graded exercise approach to assess and manage concussions, focusing on exercise tolerance and physiologic recovery, which is different from other treatments that may not incorporate exercise testing. It helps establish a safe aerobic exercise program to aid recovery, unlike treatments that rely solely on symptom reporting. ^{1 2 3 4 7}

Research Team

Anthony P Kontos, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

References

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

The Buffalo Concussion Bike Test for Concussion Assessment in Adolescents. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Sex differences in the Buffalo Concussion Treadmill Test in adolescents with acute sport-related concussion. [2021]

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

Combined Neurocognitive and Exercise Tolerance Testing Improves Objectivity of Buffalo Concussion Treadmill Test. [2023]

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

Use of graded exercise testing in concussion and return-to-activity management. [2022]

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

An Investigation of Physiological System Impairments in Individuals 4 Weeks to 6 Months Following Mild Traumatic Brain Injury. [2023]

6. United States 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. [2023]

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

Concurrent Validity of a Stationary Cycling Test and the Buffalo Concussion Treadmill Test in Adults With Concussion. [2023]