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Post-Concussion Aerobic Exercise

Primary Purpose

Concussion, Mild, Mild Traumatic Brain Injury

Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Prescription
Treadmill Test
Monitoring
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Mild focused on measuring Concussion, Mild traumatic brain injury, Aerobic exercise

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Rehabilitation Institute - University Health Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Monitoring

Monitoring + Treadmill Test

Monitoring + Treadmill Test + Specific Exercise Prescription

Arm Description

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).

In addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Recovered
"Recovery" (yes/no) will be determined using a 3-step approach: Self-reported symptoms (using the Sport Concussion Assessment Tool [SCAT], Symptom Inventory), Clinic physician's opinion, Treadmill test results (if applicable).

Secondary Outcome Measures

Percentage of Participants Recovered
Percentage of Participants Recovered
Percentage of Participants who have Returned to Work/School
Time at which participants return to part-time and/or full-time work or school activities.
Percentage of Participants who have Returned to Work/School
Percentage of Participants who have Returned to Work/School
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score
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).
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score

Full Information

First Posted
August 19, 2020
Last Updated
November 16, 2022
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04539509
Brief Title
Post-Concussion Aerobic Exercise
Official Title
The Effects of Early Prescribed Aerobic Exercise on Recovery and Post-concussive Symptoms in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Revising study protocol.
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: 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). Monitoring + Treadmill Testing- in addition to wearing the heart rate monitor, they will undergo a treadmill test at each appointment. 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: Self-reported symptoms, Clinic physician's opinion, Treadmill test results (if applicable).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild, Mild Traumatic Brain Injury
Keywords
Concussion, Mild traumatic brain injury, Aerobic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
435 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monitoring
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Monitoring + Treadmill Test
Arm Type
Placebo Comparator
Arm Description
In addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment.
Arm Title
Monitoring + Treadmill Test + Specific Exercise Prescription
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Prescription
Intervention Description
A specific exercise prescription, based on the results of a treadmill test.
Intervention Type
Behavioral
Intervention Name(s)
Treadmill Test
Intervention Description
A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.
Intervention Type
Device
Intervention Name(s)
Monitoring
Intervention Description
Activity monitoring using a Fitbit.
Primary Outcome Measure Information:
Title
Percentage of Participants Recovered
Description
"Recovery" (yes/no) will be determined using a 3-step approach: Self-reported symptoms (using the Sport Concussion Assessment Tool [SCAT], Symptom Inventory), Clinic physician's opinion, Treadmill test results (if applicable).
Time Frame
Assessed at week 8 post-concussion.
Secondary Outcome Measure Information:
Title
Percentage of Participants Recovered
Time Frame
Assessed at week 2 post-concussion.
Title
Percentage of Participants Recovered
Time Frame
Assessed at week 4 post-concussion.
Title
Percentage of Participants who have Returned to Work/School
Description
Time at which participants return to part-time and/or full-time work or school activities.
Time Frame
Assessed at week 2 post-concussion.
Title
Percentage of Participants who have Returned to Work/School
Time Frame
Assessed at week 4 post-concussion.
Title
Percentage of Participants who have Returned to Work/School
Time Frame
Assessed at week 8 post-concussion.
Title
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score
Description
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).
Time Frame
Assessed at week 2 post-concussion.
Title
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score
Time Frame
Assessed at week 4 post-concussion.
Title
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score
Time Frame
Assessed at week 8 post-concussion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Bayley, MD
Organizational Affiliation
University Health Network, Toronto Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute - University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IDP sharing plan.
Citations:
PubMed Identifier
31105634
Citation
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.
Results Reference
background
PubMed Identifier
29668716
Citation
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.
Results Reference
background
PubMed Identifier
24225521
Citation
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.
Results Reference
background

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Post-Concussion Aerobic Exercise

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