Assessing the Effects of a Clinical Exercise Protocol on Children With Post-concussion Syndrome
Post Concussion Syndrome
About this trial
This is an interventional treatment trial for Post Concussion Syndrome
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 13 and 18 (freshman - senior)
- Subject must be able to understand and sign assent form and parent/guardian must be able to understand and sign consent form
Initial injury meets the definition of mTBI as follows:
a. Traumatically induced physiological disruption of brain function by at least one of the following: i. Any period of loss of consciousness of 30 minutes or less ii. Any loss of memory for events immediately before or after accident and post-traumatic amnesia not greater than 24 hours iii. Any alteration in mental state at time of accident b. No structural lesions in the head or brain
Diagnosed with post concussive syndrome as follows:
a. Clinical SCAT-3 revised score of >22 at 3+ weeks or plateaued score for 2 weeks or more of >15 at 4+ weeks
- Continues to experience symptoms post injury and at time of enrollment
- Has had a normal MRI
- Can commit to participating for 12 weeks
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from study participation:
- Any documented structural lesions in the skull or brain
- Borderline TBI or concern that TBI is moderate rather than mild
- Any medication or condition that elevates heart rate
Sites / Locations
- University of Arizona
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Graduated Exercise Protocol
Rest followed by Protocol
Intervention involves exercise starting at 50% of maximum age-adjusted heart rate (MHR) for 10 minutes (warm-up and Recovery)_ plus 5 minutes of target heart rate per day 5 days a week for 2 weeks, supervised by the athletic trainer or parent. The protocol increases the intensity of target heart rate by 10% MHR and duration of 50% MHR by 2 minutes every 2 weeks if there is no symptom exacerbation. The exercise protocol includes treadmill speed and track minutes per lap conversion, rate of perceived exertion and talk test for each stage of exercise plus total time to execute for 5 days each week.
No activity in weeks 1 - 8. In week 9 we will begin their intervention phase as described in graduated exercise protocol