Trial of Aerobic Treadmill Exercise Treatment for Concussion
Condition: Concussion
Study type: Interventional

Summary: 
      A post-concussion syndrome (PCS) diagnosis has historically led to a recommendation of
      continued mental and physical rest to minimize symptoms. However, this conservative approach
      does not consider the pathophysiological mechanisms and neurological subsystem dysfunction
      which mediate persistent signs and symptoms. Recently, developing research is recommending
      targeted therapies for specific post-concussion disorders (physiologic, vestibulo-ocular and
      cervicogenic). The Buffalo Concussion Treadmill Test (BCTT) is a graded aerobic test that has
      emerged as safe, reliable, and effective in distinguishing between post-concussion syndrome
      sub-types, quantifying physiological recovery, and guiding return to play decision making. It
      has been proposed that the results of a BCTT can be used to prescribe progressively
      intensifying whole body aerobic exercise (such as walking or biking), maintained at a
      sub-symptom threshold, to improve autoregulatory function with the potential to improve PCS
      symptoms. Positive results with BCTT have now made it the standard of care at the University
      of Buffalo Concussion Clinic and Pan Am Clinic during the management of sport related
      concussions. Despite its increased use in patients with post-concussion syndrome there is
      currently no data on the use of exercise treatment in the early stages of concussion
      recovery.
    

Detailed description: 
      This is a randomized controlled trial of sub-threshold (symptom-threshold) exercise therapy
      versus relative rest treatment in subjects with an acute phase concussion.

      If a participant is eligible and consent has been given the neurosurgeon will conduct a
      Physical Activity Readiness Medical Examination (PARmed-X) and the participant will complete
      an exercise tolerance test on a treadmill (Visit 1) under the supervision of the neurosurgeon
      and exercise scientist. Using a standardized Balke protocol, participants will perform an
      incremental treadmill test to the point of symptom onset of exacerbation (increase of 2
      points on an overall condition Likert scale). Those who achieve a peak Heart Rate (HR) > 150
      bpm will be excluded from the study since they are close to full recovery. Those who achieve
      a HR > 120 but < 150 bpm and who cannot exercise to exhaustion (defined as a final rating of
      perceived exertion (RPE) < 17 on a Borg scale) will be randomly assigned to sub-threshold
      aerobic exercise (exercise at a HR equivalent to 80% of their HR achieved at symptom onset or
      exacerbation) or to relative rest. Any participant who does not achieve a HR > 120 bpm will
      return the following week for a repeat treadmill test (Visit 2). If they achieve a HR > 120
      bpm but cannot exercise to exhaustion during Visit 2, they will be randomly assigned to
      sub-threshold exercise or to relative rest. This is because participants must demonstrate a
      level of exercise tolerance to have a reasonable sub-threshold (80% of achieved HR) exercise
      treatment prescription.

      Participants randomized to sub-threshold aerobic exercise will be given a HR monitor and a
      specific HR intensity to exercise at 30 minutes per day. Participants randomized to rest will
      be asked to rest for 30 minutes per day (no structured physical or cognitive activity for at
      least 30 minutes per day and no participation in structured aerobic exercise during the
      entire study). After randomization, all subjects will have treadmill testing at all
      subsequent follow-ups with the neurosurgeon (every 1 to 2 weeks) to determine physiological
      recovery. All participants will be asked to document their symptom data into a form between
      7-10 PM each evening (following that day's exercise for the exercise group), along with hours
      of work/school, and minutes of exercise.

      The study end point for each subject is at recovery (as determined by a normal exercise level
      and an exam from the treating neurosurgeon).

      Data Analysis

      All statistics will be presented as mean ± SD. Data will be analyzed with a two-way analysis
      of variance to compare physiological variables for the exercise and rest groups over the
      duration of the study. Total test duration, maximum heart rate achieved and peak respiratory
      rate will be compared between the two groups with an independent samples t-test. A repeated
      measures ANOVA will be used for all questionnaire analyses. All analysis will be completed
      using SPSS 22 (IBM corp, Armonk, NY, USA) with an alpha level set at p<0.05.
    

Intervention name(s): Aerobic Exercise
Intervention type(s): Other
Intervention description(s): Patients are treated with progressive exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment