Effects of Exercise on Acute Concussion Symptoms and Recovery in Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Concussion Mild
- Mild Traumatic Brain Injury
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: 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
Participation Requirements
- Age
- Between 17 years and 55 years
- Gender
- Both males and females
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...
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).
Tracking Information
- NCT #
- NCT04539509
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Mark Bayley, MD University Health Network, Toronto Rehabilitation Institute