ClinicalTrials.gov
ClinicalTrials.gov Menu

Prescribed Light Exercise for ED Patients With MTBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03084211
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Catherine Varner, Mount Sinai Hospital, Canada

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
Contact: Catherine Varner, MD MSc 416-586-5959 catherine.varner@sinaihealthsystem.ca
Contact: Shelley McLeod, PhD(c) MSc 416-586-8330

Locations
Canada, Ontario
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         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Catherine Varner, MD MSc Sinai Health System

Responsible Party: Catherine Varner, Clinician Scientist, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT03084211     History of Changes
Other Study ID Numbers: MSHED002
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IDP will be shared with other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catherine Varner, Mount Sinai Hospital, Canada:
emergency department
concussion
head injury

Additional relevant MeSH terms:
Craniocerebral Trauma
Head Injuries, Closed
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating