NCT02432989

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 1, 2018

Status Verified

March 1, 2018

Enrollment Period

3.7 years

First QC Date

March 26, 2015

Last Update Submit

April 30, 2018

Conditions

Brain Concussion

Keywords

Exercise TherapyConcussion ManagementConcussion Recovery

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 48 hours of concussion, and 7 days post-injury

Secondary Outcomes (2)

  • Change in Subjective Symptom Reporting

    Days 1,2,3,4,5,6 through 7 inclusive post-injury

  • Differences in Activity Levels

    Days 1,2,3,4,5,6 through 7 inclusive post-injury

Study Arms (2)

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.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Light-moderate exercise on a stationary bike and leisurely walks.

Exercise Group

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fortius Sport & Health

Burnaby, British Columbia, V5B 3B8, Canada

Location

Djavad Mowafaghian Centre for Brain Health

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25560444BACKGROUND

Related Links

MeSH Terms

Conditions

Brain Concussion

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Naznin Virji-Babul, PhD, PT

    Department of Physical Therapy, University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Naznin Virji-Babul

Study Record Dates

First Submitted

March 26, 2015

First Posted

May 4, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 1, 2018

Record last verified: 2018-03

Locations

CA(2)