Post-Concussion Aerobic Exercise

Not Applicable

Withdrawn

• Conditions: Concussion, Mild; Mild Traumatic Brain Injury
• Interventions: Behavioral: Treadmill Test; Behavioral: Exercise Prescription; Device: Monitoring

• Registration Number: NCT04539509
• Lead Sponsor: University Health Network, Toronto

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:

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 Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-07
• Study Start: 2021-01-01
• Status Verified: 2022-11
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monitoring + Treadmill Test	Monitoring	In addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment.
Monitoring + Treadmill Test	Treadmill Test	In addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment.
Monitoring + Treadmill Test + Specific Exercise Prescription	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.
Monitoring	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).
Monitoring + Treadmill Test + Specific Exercise Prescription	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.
Monitoring + Treadmill Test + Specific Exercise Prescription	Treadmill Test	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Recovered	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

Name	Time	Method
Percentage of Participants who have Returned to Work/School	Assessed at week 8 post-concussion.
Percentage of Participants Recovered	Assessed at week 4 post-concussion.
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score	Assessed at week 8 post-concussion.

Trial Locations

Locations (1)

Toronto Rehabilitation Institute - University Health Network; 🇨🇦 Toronto, Ontario, Canada