Prescribed Light Exercise for ED Patients With MTBI
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Introduction:The emergency department (ED) is the first point of health care contact for most
      head injured patients. The majority (estimated 85%) of patients suffering head injury will
      not have intra-cranial damage requiring neurosurgical consultation, but may have symptoms of
      mil traumatic brain injury (MTBI). Patients with MTBI may have physical, emotional,
      behavioral, or cognitive symptoms such as headache, sleep disturbance, disorders of balance,
      fatigue, irritability, memory and concentration problems, and the majority have self-limited
      symptoms that abate within 7 to 10 days. Although early and spontaneous resolution occurs in
      most patients, a small proportion of adults with MTBI will have a protracted course. It is
      estimated between 15-30% of patients with MTBI develop post-concussion syndrome (PCS), which
      is a persistence of head injury symptoms after MTBI.3 PCS usually lasts 2-4 months, and the
      symptoms typically peak 4-6 weeks following the injury4. However, in a smaller percentage of
      patients, the symptoms of PCS last for a year or longer. Approximately 20% of adults with PCS
      will not have returned to full-time work 1 year after the initial injury, and some are
      disabled permanently by PCS.

      Current guidelines recommend a period of 'cognitive rest' and stepwise return to usual
      activities following MTBI. Cognitive rest is defined as the avoidance of mental activities
      that may trigger symptoms, such as watching television, using the computer, exercising, or
      talking on the phone. Patients following 'return to usual activity' instructions are
      encouraged to only resume normal activities once symptoms have resolved, and if symptoms
      return upon recommencement of activities, to return to rest. However, a recent systematic
      review of early educational interventions in the ED for MTBI concluded there are no clear and
      consistent interventions or standard management practices that exist for this population.
      Additionally, previous research evaluating a period of strict bed rest, which includes both
      physical and cognitive rest, has also not been shown to decrease severity or duration of MTBI
      symptoms. Based on the best available evidence, current guidelines for the management of MTBI
      suggest complete bed rest should be avoided after the first 48 hours post-injury.

      Regular exercise has been shown to have positive effects on well-being, including mental
      health, improved self esteem, sleep and memory. Recent studies including patients with PCS
      have reported exercise treatment programs improved exercise tolerance and decreased symptoms,
      even for those patients where exercise previously exacerbated PCS symptoms. Additionally,
      Wise et al., randomized patients with severe TBI to either a structured exercise program for
      10 weeks or usual care and found patients in the exercise group were less depressed and
      reported better health status compared to those not included in the exercise program.

      Rationale: Given the paucity of effective management strategies that prevent PCS following
      MTBI 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:

      Study Design and Population This randomized controlled trial will be conducted in the ED of
      an academic tertiary care hospital (annual census 60,000). Consecutive, adult (18-64 years)
      patients presenting to the ED with a MTBI sustained within the preceding 48 hours will be
      eligible for enrollment. Acute MTBI will be defined by the Zurich consensus statement as a
      direct blow to the head, face, neck or elsewhere on the body with a force transmitted to the
      head which may or may not involve loss of consciousness AND results in brain injury with 1 or
      more symptoms in 1 or more of the following clinical domains: somatic, cognitive, emotional
      or behavioral, or sleep.

      Triage nurses will screen potential patients and once eligibility is confirmed by the
      attending physician, informed written consent will be obtained from trained research
      personnel (when available) or by the attending physician or nurse. The study protocol will be
      approved by the local institutional Research Ethics Board and registered with
      clinicaltrials.gov.

      Trained research personnel will collect demographic and clinical parameters (history,
      physical examination findings, diagnostic testing, ED management) from paper and electronic
      charts using a standardized data collection tool. The research assistant will ask patients to
      complete an inventory of symptoms to establish a baseline using the Rivermead Post-Concussion
      Symptoms Questionnaire (RPQ), a validated, 16 item questionnaire and provide instructions to
      the patient regarding the wearable step counter.

      Interventions After providing informed written consent, patients will be randomized to either
      discharge instructions prescribing 30 minutes of light exercise (ie: walking) daily
      (intervention) or discharge instructions describing graduated return to usual activities and
      cognitive rest (control) using a fixed 1:1 allocation ratio produced by a computer-based
      random number generator. Block sizes of four will be used to ensure equal allocation to each
      group. To avoid potential patient selection and allocation bias, all physicians, nurses, RAs
      and patients will be blinded to the randomization schedule.

      Sealed, sequentially numbered, opaque envelopes will contain the pre-assigned group
      allocation. By necessity, the physician administering the instructions and the patient will
      be aware of their allocation. However, outcome assessors will be blinded to group assignment.

      Prior to receiving the discharge instructions, all patients will complete the RPQ
      questionnaire. Patients will be contacted via telephone at 2, 4 and 6 weeks following their
      index ED visit to repeat the RPQ questionnaire and determine if they have any subsequent
      MTBI-related physician visits and how many days of work or school they have missed due to
      MTBI symptoms. If telephone contact is not successful on the first day of scheduled
      follow-up, participants will be sent a text message to remind them of the scheduled telephone
      interview. If contact is not made within this timeframe, patients will be considered lost to
      follow-up and their data will be excluded from further analysis.

      Discharge instructions will be read by the attending physician or ED nurse. Patients will be
      provided a printed copy of the discharge instructions. All patients will receive instructions
      including a description of common symptoms following MTBI and warning signs for missed
      intracranial injury such as vomiting, stupor, focal weakness, seizure and severe headache.
      The control group discharge instructions have been adapted from the Centers for Disease
      Control and Prevention Acute Concussion Evaluation Care Plan (work version) for healthcare
      providers. These MTBI discharge instructions describe a graduated return to usual activities
      plan based on head injury symptoms and emphasized cognitive rest. 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.

      Outcome Measures 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 step counters.

      Data Analyses Data will be entered directly into a study specific Microsoft Excel database
      (Microsoft Corporation, Redmond, Washington). Descriptive statistics will be summarized using
      means with standard deviations (SD), medians with interquartile ranges (IQR) or frequencies
      with 95% confidence intervals (CIs) where appropriate. Differences in RPQ at 72 hours, 7
      days, 14 days, 30 days post ED visit between the intervention and control groups will be
      compared using paired samples t-tests. Other outcomes including included change in number of
      missed days of school or work, repeat visits to a healthcare provider, and quality of life
      indicators will be compared between groups using descriptive statistics with 95% confidence
      intervals where appropriate. Analyses will be conducted according to the intention-to-treat
      principle.

      Additionally, the tracking devices' measurements will be compared to the patients' reported
      symptoms and reported daily activity. All statistical analyses will be conducted using SAS
      (v.9.4, SAS institute, Inc., Cary, NC, USA).
    

Intervention name(s): Light exercise discharge instructions
Intervention type(s): Other
Intervention description(s): Participants in the intervention group will receive discharge instructions prescribing light exercise following mild traumatic brain injury.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: emergency department; concussion; head injury