Brain ConcussionNCT02432989
Establishing Early Exercise Interventions in Concussion Recovery
A study testing Exercise in people with Brain Concussion, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Brain Concussion
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Less than 15 years of age or over 25 years old.
- Diagnosis of concurrent learning disability, ADHD, Autism or Seizure.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Fortius Sport & Health
Burnaby, British Columbia, V5B 3B8
Djavad Mowafaghian Centre for Brain Health
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: 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.
Read the 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
- Conditions
- Brain Concussion
- Being tested
- Exercise
- Keywords
- Exercise Therapy, Concussion Management, Concussion Recovery
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Light-moderate exercise on a stationary bike and leisurely walks.
| Study group | Role | What they receive |
|---|---|---|
| Resting Control Group | No intervention | Patients will receive standard concussion management, but will be asked not to exercise for the first 7 days after their concussion. |
| Exercise Group | Experimental | 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 48 hours of concussion, and 7 days post-injury
Secondary outcomes (2)
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.
Measured: Days 1,2,3,4,5,6 through 7 inclusive post-injury
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.
Measured: Days 1,2,3,4,5,6 through 7 inclusive post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Not able to get enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Fortius Sport & Health
- Responsible party
- Principal investigator, Naznin Virji-Babul, University of British Columbia
- Investigators
- Naznin Virji-Babul, PhD, PT, Principal investigator, Department of Physical Therapy, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432989
- Sponsor's protocol ID
- H15-00307
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2015
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25560444
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rest vs. Early Return to Exercise Following Concussion (H15-00307)
- ClinicalTrials.gov ID
- NCT02432989
- Acronym / sponsor ID
- H15-00307
- Conditions
- Brain Concussion
- Keywords
- Exercise Therapy, Concussion Management, Concussion Recovery
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Not able to get enough participants
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Fortius Sport & Health
- Study start
- Apr 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resting Control Group | No intervention | –Patients will receive standard concussion management, but will be asked not to exercise for the first 7 days after their concussion. |
| Exercise Group | Experimental | Behavioral: ExercisePatients 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. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Less than 15 years of age or over 25 years old.
- Diagnosis of concurrent learning disability, ADHD, Autism or Seizure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseLight-moderate exercise on a stationary bike and leisurely walks. | Behavioural | Exercise Group |
Primary outcome
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.
2 secondary outcomes
Change in Subjective Symptom Reporting
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Background: PubMed 25560444Thomas 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.
- Perception-Action Lab WebsiteLink provided by the sponsor.
- Fortius Sport \& Health WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naznin Virji-Babul, PhD, PT principal investigator
Department of Physical Therapy, University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Brain Concussion, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EEG Functional Connectivity Using Graph Theoretical Modeling (time frame: Within 48 hours of concussion, and 7 days post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.