Establishing Early Exercise Interventions in Concussion Recovery

April 30, 2018 updated by: Naznin Virji-Babul, University of British Columbia

Rest vs. Early Return to Exercise Following Concussion (H15-00307)

This is a Phase 1 study to determine (1) the safety of an exercise protocol in adolescents and young adults with concussion in the first week post-injury and (2) to evaluate the effects of mild symptoms on brain function using EEG. This pilot study will inform subsequent grant applications, and a Phase II randomized control trial that will explore the influence of age on an early re-introduction to exercise, as well as the influence of varying intensity levels of exercise.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

The investigators will recruit a total of 20 patients between the ages of 15-25.Ten patients will be randomized to the "rest" group and ten to the "exercise" group.

All patients will then be invited to complete balance testing and a 5 minute resting state EEG at the Perception Action Lab at UBC's Djavad Mowafaghian Centre for Brain Health within 48 hours of their concussion. At this time all patients will be provided with an Actigraph GT3X+ from Actigraph Corp and requested to wear this on their wrist or ankle 24 hours a day, and record times in which the device is removed. The patients will wear this device until returning to UBC on day 7 post-injury. Daily questionnaires describing their physical and mental activity levels, and any concussion related symptoms they experienced will also be completed. This initial meeting will take approximately 90 minutes.

Afterwards, all patients will be invited to attend a standard post-concussion management visit with a physical therapist at FORTIUS Sport and Health in Burnaby BC, 48-72 hours after their injury. Both the rest and exercise groups will receive a "standard post-concussion management visit". In this visit, physical measures of c-spine range of motion (ROM), c-spine proprioception with laser (within 7 cm pass, >7 cm fail), strength, presence/absence of subjective symptoms, numeric c-spine rating scale, and neurocognitive testing will be completed. Those assigned to the exercise group will additionally complete 15 minutes of light-moderate aerobic exercise on a stationary bike. Activity levels will be determined by the physical therapist to individualize each program using heart rate reserve (HHR) and perceived exertion between 11-12 on the Visual Analogue Scale (VAS) for "Rating of Perceived Exertion". Patients will aim to achieve 65% of their HHR. The visit will take approximately 60 minutes, with an additional 20 minutes for those assigned to the exercise group.

On day 4 post-injury, all patients will continue with the standard care and recovery at home, completing their daily questionnaires of activity levels and post-concussion symptom reporting. Those assigned to the exercise group will be asked to complete 30 minutes of continuous leisurely walking at their convenience.

All patients will complete a second standard post-concussion management visit to FORTIUS Sport and Health on day 5 or 6 post-injury to repeat their standard concussion care and neurocognitive testing. Those in the exercise group will be invited to complete 30 minutes of light-moderate aerobic exercise (65% HHR) on the stationary bike following the aforementioned criteria. On the remaining day, all patients will continue with standard care and recovery at home; completing their daily questionnaires of activity levels and post-concussion symptom reporting. Those in the exercise group will again complete 30 minutes of continuous leisurely walking at their convenience while at home.

On day 7 post-injury, patients will return to UBC for a follow up appointment in which balance testing, and resting state EEG will be re-assessed. Patients will return their Actigraph, and complete a final questionnaire. At this stage, participation will be considered complete

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5B 3B8
        • Fortius Sport & Health
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Djavad Mowafaghian Centre for Brain Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Enrolled in participating minor sports association in the Greater Vancouver Area
  • Sustained a recent sports related concussion (within 48 hours of contacting the research coordinators)

Exclusion Criteria:

  • Less than 15 years of age or over 25 years old.
  • Diagnosis of concurrent learning disability, ADHD, Autism or Seizure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Resting Control Group
Patients will receive standard concussion management, but will be asked not to exercise for the first 7 days after their concussion.
Experimental: Exercise Group
Patients will receive standard concussion management, but will be asked to exercise on a stationary bike on two different occasions (once for 15 minutes and again for 30 minutes) in their first week of recovery. This group will also be asked to complete a 30 minute leisurely walk at their convenience on the two days they are not tested at UBC or Fortius.
Behavioral: Exercise
Light-moderate exercise on a stationary bike and leisurely walks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EEG Functional Connectivity Using Graph Theoretical Modeling
Time Frame: Within 48 hours of concussion, and 7 days post-injury
Compare 5 minute resting state electroencephalogram (EEG) between rest and exercise groups. We will record the electrical activity (in Hertz) and compare values using Graph Theoretical measures that establish both global and local connectivity. We will look at the changes in composite measures of betweenness, global efficiency, clustering coefficient, and hub value.
Within 48 hours of concussion, and 7 days post-injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Subjective Symptom Reporting
Time Frame: Days 1,2,3,4,5,6 through 7 inclusive post-injury
Compare changes in daily cognitive and physical symptoms between the rest and exercise groups. Symptoms are rated on a 7 point Likert Scale.
Days 1,2,3,4,5,6 through 7 inclusive post-injury
Differences in Activity Levels
Time Frame: Days 1,2,3,4,5,6 through 7 inclusive post-injury
Compare differences in activity levels between the rest and exercise groups. Activity levels are recorded by an accelerometer and will be compared to participant journal entries.
Days 1,2,3,4,5,6 through 7 inclusive post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Fortius Sport & Health

Investigators

  • Principal Investigator: Naznin Virji-Babul, PhD, PT, Department of Physical Therapy, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H15-00307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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