Years since first academic appointment: Less than 5 years
Title: Challenging the dogma: A randomized controlled trial comparing prescribed light exercise to standard management for emergency department patients with acute mild traumatic brain injury.
Full Author List: Catherine Varner, Shelley McLeod, Bjug Borgundvaag
Introduction: Current guidelines for treating patients with mild traumatic brain injury (MTBI) recommend a period of cognitive rest and gradual return to usual activities with avoidance of any activity that exacerbates symptoms. However, recent studies have reported prolonged rest beyond 48 hours might hinder MTBI recovery, and there is limited evidence to suggest following guidelines has a positive impact on prognosis. Given the paucity of effective management strategies to prevent post-concussion syndrome (PCS) and emerging evidence of the benefits of exercise in MTBI patients, there is an urgent need for more research on the effectiveness of an early exercise intervention in the acute MTBI patient population as prevention of PCS.
Research Question: Among adult (18-64 years) patients presenting to the ED with a discharge diagnosis of acute MTBI (defined by the Zurich consensus statement), does prescribing light exercise (ie: 30 min daily walking) reduce the proportion of patients with PCS at 30 days, compared to standard discharge instructions?
Methods: This will be a randomized controlled trial of adult (18-64 years) patients discharged from an academic ED diagnosed with MTBI occurring within 48 hours of the index ED visit. The intervention group will receive discharge instructions prescribing 30 minutes of light exercise (ie: walking) and the control group will be instructed to gradually return to activities. Discharge instructions will be read by the attending physician or ED nurse. Patients will be provided a printed copy of the discharge instructions. Depending on their preferences, patients will be contacted by email or by telephone to complete the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), a validated, 16 item questionnaire.
The primary outcome of this study will be the proportion of patients with PCS at 30 days, defined as an increase from baseline of ≥ 3 symptoms on the validated RPQ at 1 month. Secondary outcomes will include change in RPQ from baseline to 72 hours, 7 days, 14 days, 30 days post initial ED visit, number of missed days of school or work and repeat visits to a healthcare provider. To assess compliance with ED discharge instructions, patients will be asked to complete a daily activity journal and will be given fitness tracking devices.
Sample Size: Predicting 30% of the control group will have PCS at 30 days, and assuming an alpha of 0.05 and beta of 0.2, to detect a 15% absolute risk difference, we estimate that 236 participants will have to be enrolled (118 in each group) to reject the null hypothesis that the proportion of patients with PCS is not different between the two groups. To account for potential attrition, we have increased our sample size by 25% and plan to enroll 330 patients, 165 in each group.
Impact: This study will be the first to clinically evaluate the impact of light exercise on acute MTBI patients discharged from the ED. If proven effective, a prescription for light and early exercise may reduce the incidence PCS and facilitate return to activity in the MTBI patient population commonly cared for in the ED.
Questions for the audience:
- We would like to conduct this in a few other EDs, but have very limited funding to complete the trial. Would anyone be interested in participating considering we cannot compensate them for their efforts?
- We would like to use fitness tracking devices to help measure compliance with discharge instructions. Do you think this aspect is seen as a weakness in the study protocol or a novel idea? If utilized, we would also compare patient reported activity versus fitness tracking device-reported activity.