Effects of Exercise on Acute Concussion Symptoms and Recovery in Adults

• ClinicalTrials.gov Identifier: NCT04539509
• Recruitment Status: Suspended
• First Posted: September 7, 2020
• Last Update Posted: October 6, 2021
• Sponsor: University Health Network, Toronto
• Information provided by (Responsible Party): University Health Network, Toronto

Study Description

Brief Summary:

This study is looking at the specific role of an exercise prescription on recovery from concussion symptoms in the general population.

Condition or disease	Intervention/treatment	Phase
Concussion, Mild; Mild Traumatic Brain Injury	Behavioral: Exercise Prescription; Behavioral: Treadmill Test; Device: Monitoring	Not Applicable

Detailed Description:

435 people will participate in this study.

A physician will review a participant's medical history to determine if physical activity is appropriate for them. They will then be randomly assigned to 1 of 3 study groups:

1. Monitoring- participants will be given a heart rate monitor to wear on their wrist for the duration of the study (until "recovered", or until 8 weeks post-concussion, whatever comes first).
2. Monitoring + Treadmill Testing- in addition to wearing the heart rate monitor, they will undergo a treadmill test at each appointment.
3. Monitoring + Treadmill Testing + Specific Exercise Prescription- in addition to wearing the heart rate monitor, and treadmill test, they will receive an exercise prescription based on the results of the treadmill test.

The randomization is by chance. Participants have a 40/20/40% respective chance of being assigned to the study groups above. This means that out of every 5 people: 2 people will be assigned to the group 1, 1 will be assigned to the group 2, and 2 will be assigned to the group 3. Both participants and the study doctor will be aware which group participants are in.

Regardless of the group assigned, participants will receive an exercise prescription form at each appointment, as per usual care. The prescription will be based on the physician's judgement. If a participant is in group 3, their prescription will also take into account the results of the treadmill test.

Recovery will be determined using a 3-step approach:

1. Self-reported symptoms,
2. Clinic physician's opinion,
3. Treadmill test results (if applicable).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 435 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: The Development of a Rapid Access Concussion Care and Research Clinic - Effects of Exercise on Acute Concussed Adults Referred to a Rapid Access Concussion Clinic
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: August 2024
• Estimated Study Completion Date: December 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Monitoring; Participants 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).	Device: Monitoring; Activity monitoring using a Fitbit.
Placebo Comparator: Monitoring + Treadmill Test; In addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment.	Behavioral: Treadmill Test; A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.; Device: Monitoring; Activity monitoring using a Fitbit.
Experimental: Monitoring + Treadmill Test + Specific Exercise Prescription; In 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.	Behavioral: Exercise Prescription; A specific exercise prescription, based on the results of a treadmill test.; Behavioral: Treadmill Test; A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.; Device: Monitoring; Activity monitoring using a Fitbit.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Recovered [ Time Frame: Assessed at week 8 post-concussion. ]

   "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).

Secondary Outcome Measures :

1. Percentage of Participants Recovered [ Time Frame: Assessed at week 2 post-concussion. ]
2. Percentage of Participants Recovered [ Time Frame: Assessed at week 4 post-concussion. ]
3. Percentage of Participants who have Returned to Work/School [ Time Frame: Assessed at week 2 post-concussion. ]
   Time at which participants return to part-time and/or full-time work or school activities.
4. Percentage of Participants who have Returned to Work/School [ Time Frame: Assessed at week 4 post-concussion. ]
5. Percentage of Participants who have Returned to Work/School [ Time Frame: Assessed at week 8 post-concussion. ]
6. Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score [ Time Frame: Assessed at week 2 post-concussion. ]

   Measured using the Brief Symptom Inventory (BSI)-18. Global scores, as well as somatization, depression, and anxiety sub-scales will be included.

   Global scores are calculated by adding up participants self-reported score (0-72), with high scores indicating more psychological distress. These scores are then compared to gender-stratified norms. Sub-scales are scored on a 0-24 scale, again higher scores indicating more psychological distress (sub-scales also compared to gender-stratified norms).

7. Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score [ Time Frame: Assessed at week 4 post-concussion. ]
8. Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score [ Time Frame: Assessed at week 8 post-concussion. ]

Eligibility Criteria

• Ages Eligible for Study: 17 Years to 55 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Canada, Ontario

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Canada, M5G 2A2

Sponsors and Collaborators

University Health Network, Toronto

Investigators

• Principal Investigator: Mark Bayley, MD; University Health Network, Toronto Rehabilitation Institute

More Information

Publications:

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.

Lawrence 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.

Leddy 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. Review.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT04539509
• Other Study ID Numbers: CAPCR ID: 15-9214
• First Posted: September 7, 2020
• Last Update Posted: October 6, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No IDP sharing plan.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:

Concussion; Mild traumatic brain injury; Aerobic exercise

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating