Establishing Early Exercise Interventions in Concussion Recovery
Primary Purpose
Brain Concussion
Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Brain Concussion focused on measuring Exercise Therapy, Concussion Management, Concussion Recovery
Eligibility Criteria
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.
Sites / Locations
- Fortius Sport & Health
- Djavad Mowafaghian Centre for Brain Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Resting Control Group
Exercise Group
Arm Description
Patients will receive standard concussion management, but will be asked not to exercise for the first 7 days after their concussion.
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.
Outcomes
Primary Outcome Measures
Change in EEG Functional Connectivity Using Graph Theoretical Modeling
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.
Secondary Outcome Measures
Change in Subjective Symptom Reporting
Compare changes in daily cognitive and physical symptoms between the rest and exercise groups. Symptoms are rated on a 7 point Likert Scale.
Differences in Activity Levels
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.
Full Information
NCT ID
NCT02432989
First Posted
March 26, 2015
Last Updated
April 30, 2018
Sponsor
University of British Columbia
Collaborators
Fortius Sport & Health
1. Study Identification
Unique Protocol Identification Number
NCT02432989
Brief Title
Establishing Early Exercise Interventions in Concussion Recovery
Official Title
Rest vs. Early Return to Exercise Following Concussion (H15-00307)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Suspended
Why Stopped
Not able to get enough participants
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Fortius Sport & Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion
Keywords
Exercise Therapy, Concussion Management, Concussion Recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resting Control Group
Arm Type
No Intervention
Arm Description
Patients will receive standard concussion management, but will be asked not to exercise for the first 7 days after their concussion.
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Light-moderate exercise on a stationary bike and leisurely walks.
Primary Outcome Measure Information:
Title
Change in EEG Functional Connectivity Using Graph Theoretical Modeling
Description
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.
Time Frame
Within 48 hours of concussion, and 7 days post-injury
Secondary Outcome Measure Information:
Title
Change in Subjective Symptom Reporting
Description
Compare changes in daily cognitive and physical symptoms between the rest and exercise groups. Symptoms are rated on a 7 point Likert Scale.
Time Frame
Days 1,2,3,4,5,6 through 7 inclusive post-injury
Title
Differences in Activity Levels
Description
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.
Time Frame
Days 1,2,3,4,5,6 through 7 inclusive post-injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naznin Virji-Babul, PhD, PT
Organizational Affiliation
Department of Physical Therapy, University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fortius Sport & Health
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5B 3B8
Country
Canada
Facility Name
Djavad Mowafaghian Centre for Brain Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25560444
Citation
Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):213-23. doi: 10.1542/peds.2014-0966. Epub 2015 Jan 5.
Results Reference
background
Links:
URL
http://pal.rehab.med.ubc.ca/
Description
Perception-Action Lab Website
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Establishing Early Exercise Interventions in Concussion Recovery
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