Study Stopped
Revising study protocol.
Post-Concussion Aerobic Exercise
The Effects of Early Prescribed Aerobic Exercise on Recovery and Post-concussive Symptoms in Adults
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
This study is looking at the specific role of an exercise prescription on recovery from concussion symptoms in the general population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2021
Longer than P75 for not_applicable
1 active site
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
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedDecember 13, 2023
November 1, 2022
3.6 years
August 19, 2020
December 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Recovered
"Recovery" (yes/no) will be determined using a 3-step approach: 1. Self-reported symptoms (using the Sport Concussion Assessment Tool \[SCAT\], Symptom Inventory), 2. Clinic physician's opinion, 3. Treadmill test results (if applicable).
Assessed at week 8 post-concussion.
Secondary Outcomes (8)
Percentage of Participants Recovered
Assessed at week 2 post-concussion.
Percentage of Participants Recovered
Assessed at week 4 post-concussion.
Percentage of Participants who have Returned to Work/School
Assessed at week 2 post-concussion.
Percentage of Participants who have Returned to Work/School
Assessed at week 4 post-concussion.
Percentage of Participants who have Returned to Work/School
Assessed at week 8 post-concussion.
- +3 more secondary outcomes
Study Arms (3)
Monitoring
ACTIVE COMPARATORParticipants will be given a heart rate monitor to wear on their wrist for the duration of the study (i.e. until recovered, or 8 weeks post-injury, whatever comes first).
Monitoring + Treadmill Test
PLACEBO COMPARATORIn addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment.
Monitoring + Treadmill Test + Specific Exercise Prescription
EXPERIMENTALIn addition to wearing the heart rate monitor, and completing a treadmill test at each appointment, participants will receive an exercise prescription based on the results of the treadmill test. They will be prescribed 30 minutes of structured aerobic exercise, 5 times per week, at a heart rate determined by their treadmill test.
Interventions
A specific exercise prescription, based on the results of a treadmill test.
A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.
Activity monitoring using a Fitbit.
Eligibility Criteria
You may qualify if:
- Patients that provide written informed consent prior to entry into the study
- Patients referred from the emergency department (ED) with recent (\<1 week) diagnosis of concussion by ED physician
- GCS score of 13-15 on presentation to the ED
- SCAT score \> 9 at week 1
- Physician cleared for exercise; low risk for cardiac disease (defined as no cardiopulmonary symptoms and meet no more than one risk factor for heart disease)
- Willing to exercise
You may not qualify if:
- Evidence of intracranial hemorrhage, contusion or injury on brain imaging (CT Scan)
- Beta-blocker medication
- High dose (\>50mg/day) tricyclic antidepressant medication
- Pre-existing or current orthopedic injuries preventing exercise
- Pre-existing vestibular disease preventing exercise
- Heartrate increase \<30 bpm from rest on treadmill test
- Deemed asymptomatic from concussion by clinic physician
- Unable/unwilling to follow commands
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, M5G 2A2, Canada
Related Publications (3)
Haider MN, Leddy JJ, Wilber CG, Viera KB, Bezherano I, Wilkins KJ, Miecznikowski JC, Willer BS. The Predictive Capacity of the Buffalo Concussion Treadmill Test After Sport-Related Concussion in Adolescents. Front Neurol. 2019 Apr 24;10:395. doi: 10.3389/fneur.2019.00395. eCollection 2019.
PMID: 31105634BACKGROUNDLawrence DW, Richards D, Comper P, Hutchison MG. Earlier time to aerobic exercise is associated with faster recovery following acute sport concussion. PLoS One. 2018 Apr 18;13(4):e0196062. doi: 10.1371/journal.pone.0196062. eCollection 2018.
PMID: 29668716BACKGROUNDLeddy JJ, Willer B. Use of graded exercise testing in concussion and return-to-activity management. Curr Sports Med Rep. 2013 Nov-Dec;12(6):370-6. doi: 10.1249/JSR.0000000000000008.
PMID: 24225521BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Bayley, MD
University Health Network, Toronto Rehabilitation Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The primary outcome (recovery) is determined using a 3 step approach. Each assessor responsible for one of the three steps, will be blind to at least ONE other recovery determinant.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2020
First Posted
September 7, 2020
Study Start
January 1, 2021
Primary Completion
August 1, 2024
Study Completion
December 1, 2024
Last Updated
December 13, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share
No IDP sharing plan.