Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-01-01
2024-12-31
Brief Summary
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Detailed Description
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A physician will review a participant's medical history to determine if physical activity is appropriate for them. They will then be randomly assigned to 1 of 3 study groups:
1. Monitoring- participants will be given a heart rate monitor to wear on their wrist for the duration of the study (until "recovered", or until 8 weeks post-concussion, whatever comes first).
2. Monitoring + Treadmill Testing- in addition to wearing the heart rate monitor, they will undergo a treadmill test at each appointment.
3. Monitoring + Treadmill Testing + Specific Exercise Prescription- in addition to wearing the heart rate monitor, and treadmill test, they will receive an exercise prescription based on the results of the treadmill test.
The randomization is by chance. Participants have a 40/20/40% respective chance of being assigned to the study groups above. This means that out of every 5 people: 2 people will be assigned to the group 1, 1 will be assigned to the group 2, and 2 will be assigned to the group 3. Both participants and the study doctor will be aware which group participants are in.
Regardless of the group assigned, participants will receive an exercise prescription form at each appointment, as per usual care. The prescription will be based on the physician's judgement. If a participant is in group 3, their prescription will also take into account the results of the treadmill test.
Recovery will be determined using a 3-step approach:
1. Self-reported symptoms,
2. Clinic physician's opinion,
3. Treadmill test results (if applicable).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Monitoring
Participants will be given a heart rate monitor to wear on their wrist for the duration of the study (i.e. until recovered, or 8 weeks post-injury, whatever comes first).
Monitoring
Activity monitoring using a Fitbit.
Monitoring + Treadmill Test
In addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment.
Treadmill Test
A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.
Monitoring
Activity monitoring using a Fitbit.
Monitoring + Treadmill Test + Specific Exercise Prescription
In addition to wearing the heart rate monitor, and completing a treadmill test at each appointment, participants will receive an exercise prescription based on the results of the treadmill test. They will be prescribed 30 minutes of structured aerobic exercise, 5 times per week, at a heart rate determined by their treadmill test.
Exercise Prescription
A specific exercise prescription, based on the results of a treadmill test.
Treadmill Test
A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.
Monitoring
Activity monitoring using a Fitbit.
Interventions
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Exercise Prescription
A specific exercise prescription, based on the results of a treadmill test.
Treadmill Test
A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.
Monitoring
Activity monitoring using a Fitbit.
Eligibility Criteria
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Inclusion Criteria
* Patients referred from the emergency department (ED) with recent (\<1 week) diagnosis of concussion by ED physician
* GCS score of 13-15 on presentation to the ED
* SCAT score \> 9 at week 1
* Physician cleared for exercise; low risk for cardiac disease (defined as no cardiopulmonary symptoms and meet no more than one risk factor for heart disease)
* Willing to exercise
Exclusion Criteria
* Beta-blocker medication
* High dose (\>50mg/day) tricyclic antidepressant medication
* Pre-existing or current orthopedic injuries preventing exercise
* Pre-existing vestibular disease preventing exercise
* Heartrate increase \<30 bpm from rest on treadmill test
* Deemed asymptomatic from concussion by clinic physician
* Unable/unwilling to follow commands
17 Years
55 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Mark Bayley, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto Rehabilitation Institute
Locations
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Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, Canada
Countries
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References
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Haider MN, Leddy JJ, Wilber CG, Viera KB, Bezherano I, Wilkins KJ, Miecznikowski JC, Willer BS. The Predictive Capacity of the Buffalo Concussion Treadmill Test After Sport-Related Concussion in Adolescents. Front Neurol. 2019 Apr 24;10:395. doi: 10.3389/fneur.2019.00395. eCollection 2019.
Lawrence DW, Richards D, Comper P, Hutchison MG. Earlier time to aerobic exercise is associated with faster recovery following acute sport concussion. PLoS One. 2018 Apr 18;13(4):e0196062. doi: 10.1371/journal.pone.0196062. eCollection 2018.
Leddy JJ, Willer B. Use of graded exercise testing in concussion and return-to-activity management. Curr Sports Med Rep. 2013 Nov-Dec;12(6):370-6. doi: 10.1249/JSR.0000000000000008.
Other Identifiers
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15-9214
Identifier Type: OTHER
Identifier Source: secondary_id
20-5899
Identifier Type: -
Identifier Source: org_study_id