Prescribed Light Exercise for ED Patients With MTBI

NCT03084211 | Completed DMC

• 1 other identifier: MSHED002
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Traumatic Brain Injury

Keywords

emergency department; concussion; head injury

Outcome Measures

Primary Outcomes (1)

• proportion of patients with PCS

  Defined as an increase from baseline of ≥ 3 symptoms on the validated Rivermead Post-Concussion Symptoms Questionnaire

  30 days

Secondary Outcomes (3)

• Change in RPQ from baseline

  72 hours, 7 days, 14 days, 30 days post initial ED visit

• Days of school or work missed

  72 hours, 7 days, 14 days, 30 days post initial ED visit

• Return visits to a health care provider

  72 hours, 7 days, 14 days, 30 days post initial ED visit

Study Arms (2)

Control Group

NO INTERVENTION

The control group will be instructed to gradually return to activities.

Prescribed Light Exercise Group

EXPERIMENTAL

Intervention: Prescribed Light Exercise Group will receive discharge instructions prescribing 30 minutes of light exercise (ie: walking).

Other: Light exercise discharge instructions

Interventions

Light exercise discharge instructions OTHER

Participants in the intervention group will receive discharge instructions prescribing light exercise following mild traumatic brain injury.

Prescribed Light Exercise Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- MTBI occurring within 48 hours of the index emergency department visit

You may not qualify if:

• Acute intracranial injury identified on head CT
• Multisystem injuries prohibiting light exercise
• Existing medical condition that would compromise ability to participate in light exercise
• GCS \< 15 at time of ED discharge
• Underlying neurological condition resulting in communication difficulties
• Insurmountable language barrier
• Inability to follow-up via telephone
• Alcohol or drug intoxication

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

• Varner CE, Thompson C, de Wit K, Borgundvaag B, Houston R, McLeod S. A randomized trial comparing prescribed light exercise to standard management for emergency department patients with acute mild traumatic brain injury. Acad Emerg Med. 2021 May;28(5):493-501. doi: 10.1111/acem.14215. Epub 2021 Feb 28.

  PMID: 33481332 DERIVED

MeSH Terms

Conditions

Brain Concussion; Emergencies; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Varner, MD MSc

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 20, 2017
• Study Start: June 19, 2017
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)