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Prescribed Light Exercise for ED Patients With MTBI

NCT03084211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2020-02-20

No results posted yet for this study

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

Interventions

OTHER

Light exercise discharge instructions

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

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Catherine Varner, MD MSc · Sinai Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2019-10-03
Completion
2019-10-03

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03084211 on ClinicalTrials.gov