An interventional study of Exercise Prescription and Treadmill Test in Concussion, Mild and Mild Traumatic Brain Injury, sponsored by University Health Network, Toronto. Withdrawn at 1 site in Canada. Open to participants aged 17 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
This study is looking at the specific role of an exercise prescription on recovery from concussion symptoms in the general population.
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:
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:
550 studies on the registry are indexed under Brain Concussion; 154 are open to participants now.
Browse Brain Concussion studies →University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
In addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment.
Behavioral: Treadmill Test · Device: Monitoring
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 · Behavioral: Treadmill Test · Device: Monitoring
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.
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).
Time frame: Assessed at week 8 post-concussion.
Percentage of Participants Recovered
Time frame: Assessed at week 2 post-concussion.
Percentage of Participants Recovered
Time frame: Assessed at week 4 post-concussion.
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.
Time frame: Assessed at week 2 post-concussion.
Percentage of Participants who have Returned to Work/School
Time frame: Assessed at week 4 post-concussion.
Percentage of Participants who have Returned to Work/School
Time frame: Assessed at week 8 post-concussion.
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).
Time frame: Assessed at week 2 post-concussion.
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score
Time frame: Assessed at week 4 post-concussion.
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score
Time frame: Assessed at week 8 post-concussion.
Plan to share: No — No IDP sharing plan.
This study is withdrawn, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Health Network, Toronto →