NCT04539509

Post-Concussion Aerobic Exercise

The Effects of Early Prescribed Aerobic Exercise on Recovery and Post-concussive Symptoms in Adults

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 17 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Concussion, Mild
• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Prescription	A specific exercise prescription, based on the results of a treadmill test.
BEHAVIORAL	Treadmill Test	A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.
DEVICE	Monitoring	Activity monitoring using a Fitbit.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-08-01
• Completion: 2024-12-01
• First posted: 2020-09-07
• Last updated: 2023-12-13

Locations

1 site across 1 country: Canada