Post-Concussion Aerobic Exercise

University Health Network, Toronto

Status: Withdrawn

Conditions: Mild Traumatic Brain Injury; Concussion, Mild

Treatments: Behavioral: Treadmill Test; Behavioral: Exercise Prescription; Device: Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04539509

20-5899

15-9214 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Sex: All

Ages: 17 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

Monitoring

Active Comparator group

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).

Treatment:

Device: Monitoring

Monitoring + Treadmill Test

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Treadmill Test

Device: Monitoring

Monitoring + Treadmill Test + Specific Exercise Prescription

Experimental group

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.

Treatment:

Behavioral: Treadmill Test

Device: Monitoring

Behavioral: Exercise Prescription