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| ID | Type | Description | Link |
|---|---|---|---|
| 15-9214 | Other Identifier | University Health Network REB - Legacy ID |
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Revising study protocol.
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This study is looking at the specific role of an exercise prescription on recovery from concussion symptoms in the general population.
435 people will participate in this study.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring | Active Comparator | 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). |
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| Monitoring + Treadmill Test | Placebo Comparator | In addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment. |
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| Monitoring + Treadmill Test + Specific Exercise Prescription | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Prescription | Behavioral | A specific exercise prescription, based on the results of a treadmill test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Recovered | "Recovery" (yes/no) will be determined using a 3-step approach:
| Assessed at week 8 post-concussion. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Recovered | Assessed at week 2 post-concussion. | |
| Percentage of Participants Recovered | Assessed at week 4 post-concussion. | |
| Percentage of Participants who have Returned to Work/School |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Bayley, MD | University Health Network, Toronto Rehabilitation Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Rehabilitation Institute - University Health Network | Toronto | Ontario | M5G 2A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31105634 | Background | 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. | |
| 29668716 | Background |
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No IDP sharing plan.
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The primary outcome (recovery) is determined using a 3 step approach. Each assessor responsible for one of the three steps, will be blind to at least ONE other recovery determinant.
| Treadmill Test | Behavioral | A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol. |
|
| Monitoring | Device | Activity monitoring using a Fitbit. |
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Time at which participants return to part-time and/or full-time work or school activities. |
| Assessed at week 2 post-concussion. |
| Percentage of Participants who have Returned to Work/School | Assessed at week 4 post-concussion. |
| Percentage of Participants who have Returned to Work/School | Assessed at week 8 post-concussion. |
| Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score | Measured using the Brief Symptom Inventory (BSI)-18. Global scores, as well as somatization, depression, and anxiety sub-scales will be included. Global scores are calculated by adding up participants self-reported score (0-72), with high scores indicating more psychological distress. These scores are then compared to gender-stratified norms. Sub-scales are scored on a 0-24 scale, again higher scores indicating more psychological distress (sub-scales also compared to gender-stratified norms). | Assessed at week 2 post-concussion. |
| Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score | Assessed at week 4 post-concussion. |
| Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score | Assessed at week 8 post-concussion. |
| 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. |
| 24225521 | Background | 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. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |