The Effect of a Sub-symptom Threshold Aerobic Exercise Program on Recovery in Concussed Athletes
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Concussion, Mild, Rehabilitation
In brief
The purpose of this randomized controlled trial is to examine whether systematic sub-threshold exercise is effective in improving recovery time in athletes after sport related concussion (SRC) compared to those who participate in a placebo/stretching protocol. subjects will be randomized into either an Exercise group or a Placebo/stretching group. subjects in the Exercise group will participate in an individualized exercise program supervised by their athletic trainer while the Placebo/stretching group will engage in a standardized stretching routine supervised by their athletic trainer throughout the duration of their recovery. Hypothesis 1: subjects in the aerobic Exercise group will require fewer days to recover from SRC than those who follow a placebo/stretching protocol. Hypothesis 2: heart rate threshold (HRt) achieved on the graded treadmill test will be associated with days to recovery (i.e., the lower the HRt, the longer the time to recovery). Hypothesis 3: Vestibular Ocular Motor Screen (VOMS) performance will be indicative of time to clinical recovery from concussion as evidenced by a strong correlation between VOMS score and days to clinical recovery. Hypothesis 4: Sub-threshold aerobic exercise will facilitate improvement in VOMS post-concussion. Hypothesis 5: subjects in the aerobic exercise group will demonstrate greater dynamic stability as evidenced by greater reach in each of the 3 primary directions (anterior, posterior medial and posterior lateral) for their right and left lower extremity.
Key facts
- Study ID
- NCT03865433
- Run by
- Rocky Mountain University of Health Professions
- People needed
- 65
- Starts
- 2019-02-27
- Expected to finish
- 2020-07-01
- Last updated by the study team
- 2019-08-20
Who can join
Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- are aged 13-17, years and a high school student-athlete who attends school where an athletic trainer can supervise the exercise protocol;
- have sustained a concussion within 2-7 days of clinic presentation and diagnosed by a study physician;
- demonstrate symptom exacerbation during a graded treadmill exercise test and cannot complete the test;
- are currently participating in a school or club sport;
- are English speaking and capable of giving assent
You may not qualify if…
- have a reported history of neurological condition or disorder including but not limited to brain surgery, special education, seizure disorder, speech pathology, previous diagnosis of Post-Concussion Syndrome (PCS),
- are unwilling to exercise,
- have focal neurologic deficit that would represent risk for walking/running on treadmill,
- exhibit an inability to exercise due to injury, known heart disease, or increased cardiac risk,
- have experienced more than 3 previous concussions,
- have suffered a substantial comorbidity (eg,cervical injury),
- currently taking β-blockers, calcium channel blockers, or prophylactic headache medications (e.g., amitriptyline, topiramate), or
- have a resting blood pressure of > 140/90.
- If the potential participant or parent/guardian is unable to fully understand the study protocol or study risks due to injury or developmental delay, the potential participant will be excluded from the study.
Where it is running
- Oregon Health and Science University — Portland, Oregon, United States (enrolling)
Full record on ClinicalTrials.gov
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