Prescribed Light Exercise for ED Patients With MTBI
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|ClinicalTrials.gov Identifier: NCT03084211|
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : June 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Traumatic Brain Injury||Other: Light exercise discharge instructions||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial Comparing Prescribed Light Exercise to Standard Management for Emergency Department Patients With Acute Mild Traumatic Brain Injury.|
|Actual Study Start Date :||June 19, 2017|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
No Intervention: Control Group
The control group will be instructed to gradually return to activities.
Experimental: Prescribed Light Exercise Group
Intervention: Prescribed Light Exercise Group will receive discharge instructions prescribing 30 minutes of light exercise (ie: walking).
Other: Light exercise discharge instructions
Participants in the intervention group will receive discharge instructions prescribing light exercise following mild traumatic brain injury.
- proportion of patients with PCS [ Time Frame: 30 days ]Defined as an increase from baseline of ≥ 3 symptoms on the validated Rivermead Post-Concussion Symptoms Questionnaire
- Change in RPQ from baseline [ Time Frame: 72 hours, 7 days, 14 days, 30 days post initial ED visit ]Between group differences of changes in RPQ will be compared.
- Days of school or work missed [ Time Frame: 72 hours, 7 days, 14 days, 30 days post initial ED visit ]Between group differences will be compared.
- Return visits to a health care provider [ Time Frame: 72 hours, 7 days, 14 days, 30 days post initial ED visit ]Between group differences will be compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084211
|Contact: Catherine Varner, MD MScfirstname.lastname@example.org|
|Contact: Shelley McLeod, PhD(c) MSc||416-586-8330|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Contact: Catherine E Varner, MD 416-586-5054 CVarner@mtsinai.on.ca|
|Principal Investigator: Catherine E Varner, MD|
|Principal Investigator:||Catherine Varner, MD MSc||Sinai Health System|