The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion

Study Overview
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Brief Summary
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Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.

Detailed Description
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There has been recent change to the management of concussion, including the addition of exercise while a patient may still be experiencing symptoms. Some patients will be given a dose-dependent exercise prescription based on their own sub-maximal output. They will aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom duration is tracked. Some patients will only follow physician prescribed exercise, while undergoing the same heart rate and symptom monitoring for 8 weeks.

Official Title
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The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion

Conditions
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Concussion, Mild, Concussion, Brain, Concussion, Severe, Exertion; Excess

Intervention / Treatment
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* Other: Sub-maximal exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Experienced a concussion within the last 2 weeks. Concussion will be diagnosed by board-certified sports medicine physicians, and defined as a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment Low or moderate cardiac risk according to American College of Sports Medicine Post-Concussion Symptom Scale (PCSS) score greater than 9 Exclusion Criteria: History of neurological surgery Seizure disorder Use of medication or medical device that would alter heart rate, blood pressure or autonomic function Any current, serious, chronic medical or psychiatric disease that, in the Principal Investigator's judgment, may interfere with study participation or data integrity Unable or unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 21 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
Interventional Model Description: Patients will be randomly assigned to either the exercise intervention group or the usual care group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention Group<br>Thse patients will undergo a sub-maximal exercise training as treatment for concussion. | Other: Sub-maximal exercise<br>* Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.<br>|
| No Intervention: Usual Care Group<br>These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vasoreactivity During Exercise at Baseline and 8-week Visits. | Cerebral vasoreactivity was determined by assessing cerebrovascular conductance response to incremental hypercapnia elicited by rebreathing. Participants were fitted with a mouthpiece attached to a three-way respiratory valve unit, which, in turn, was attached to a 5-L rubber rebreathing bag. The valve allowed for an instantaneous switch from room air to the rebreathing bag, which had been prefilled with room air. EtCO2 was measured continuously via a sample line connecting the mouthpiece to an infrared CO2 analyzer. | Measured at initial visit and 8-weeks. | 
| Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. | Symptoms measured by the Post-concussion Symptom Inventory (PSCI). The PCSI ranges from 0-150 for symptom severity. The greater the number of symptoms reported, the more symptomatic the participant is. The forms focus on symptoms in the cognitive, emotional, sleep, and physical domains. There are 25 possible symptoms total. Participants answer on a scale of 0-6 for symptom severity (0- not a problem, 3- moderate problem, 6- severe problem). | The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-tidal CO2 | Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits. | Measured at initial visit and 8-week post injury visit. | 
| Heart Rate | Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits. | Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic. | 
| Volume of Self-reported Exercise Per Week | Volume exercise was monitored by self-reported exercise diary. All participants were asked to track their exercise and complete weekly exercise logs for the 8-week study duration. The participants randomized into the Exercise Intervention Group were prescribed a specific heart rate to exercise 5x/week for 8-weeks. Heart rate was determined by their performance from the corresponding exercise testing visit. Participants enrolled in the Usual Care Group were not prescribed any specific exercise. These participants were instructed to follow their Doctors requests. Values are presented as average minutes of exercise throughout the 8-week study period. | Average volume of exercise (min) that was self-reported by participants over the 8-week study period. | 
| Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. | Using the Borg Scale. The Borg scale is a way of measuring physical intensity level. The scale ranges from 6- no exertion at all, to 20- maximal exertion. The higher the RPE reported, the harder the participant perceives themselves to be physically working. | Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic |