Post-Concussion Aerobic Exercise

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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). Monitoring + Treadmill Testing- in addition to wearing the heart rate monitor, they will undergo a treadmill test at each appointment. 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: Self-reported symptoms, Clinic physician's opinion, Treadmill test results (if applicable).

Official Title
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The Effects of Early Prescribed Aerobic Exercise on Recovery and Post-concussive Symptoms in Adults

Conditions
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Concussion, Mild, Mild Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Exercise Prescription
* Behavioral: Treadmill Test
* Device: Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that provide written informed consent prior to entry into the study 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: Evidence of intracranial hemorrhage, contusion or injury on brain imaging (CT Scan) 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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monitoring<br>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). | Device: Monitoring<br>* Activity monitoring using a Fitbit.<br>|
| Placebo Comparator: Monitoring + Treadmill Test<br>In addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment. | Behavioral: Treadmill Test<br>* A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.<br>Device: Monitoring<br>* Activity monitoring using a Fitbit.<br>|
| Experimental: Monitoring + Treadmill Test + Specific Exercise Prescription<br>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. | Behavioral: Exercise Prescription<br>* A specific exercise prescription, based on the results of a treadmill test.<br>Behavioral: Treadmill Test<br>* A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.<br>Device: Monitoring<br>* Activity monitoring using a Fitbit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Recovered | Recovery (yes/no) will be determined using a 3-step approach: Self-reported symptoms (using the Sport Concussion Assessment Tool [SCAT], Symptom Inventory), Clinic physician's opinion, Treadmill test results (if applicable). | Assessed at week 8 post-concussion. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion, Mild traumatic brain injury, Aerobic exercise