The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
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|ClinicalTrials.gov Identifier: NCT03170856|
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Concussion, Mild Concussion, Brain Concussion, Severe Exertion; Excess||Other: Sub-maximal exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomly assigned to either the exercise intervention group or the usual care group.|
|Masking:||None (Open Label)|
|Official Title:||The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||August 2020|
Experimental: Exercise Intervention Group
Thse patients will undergo a sub-maximal exercise training as treatment for concussion.
Other: Sub-maximal exercise
Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 60 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.
No Intervention: Usual Care Group
These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.
- Change in Regional Cerebral Blood Flow during exercise [ Time Frame: Measured at initial visit, 4 weeks and 8weeks to look for a change in blood flow to the brain as a person becomes asymptomatic. ]Using transcranial Doppler ultrasound to look at blood oxygenation levels at the prefrontal cortex during sub-maximal exercise testing.
- Change Concussion symptoms over the course of an exercise intervention [ Time Frame: Will be a repeated measure at the time of injury, 4 weeks and 8 weeks, to look for a change in symptom score. ]Measured by the Post-concussion Symptom Inventory
- End-tidal CO2 [ Time Frame: Measured at initial visit, 4 weeks and 8 weeks to look for a change as a person becomes asymptomatic. ]Will be monitored using infrared analyzer during sub-maximal exercise testing.
- Heart rate [ Time Frame: Measured at initial visit, 4 weeks and 8 weeks to look for a change as a person becomes asymptomatic. ]Monitored via standard 3 lead ECG during sub-maximal exercise testing.
- Heart rate workout [ Time Frame: This will be monitored at every time point a participant exercises. 5 times a week for 8 weeks to see if their steady state heart rate increase, decreases or stays the same as they heal from their concussion. ]Monitored via polar watch, while the participant exercise at home based on their exercise prescription.
- Rate of Perceived Exhaustion [ Time Frame: Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic ]Using the Borg Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170856
|Contact: David Howell, PhD||720-777-1502 ext 71502||David.Howell@UCDenver.edu|
|Contact: William Meehan, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital||Recruiting|
|Cambridge, Massachusetts, United States, 02138|
|Contact: Can Tan, PhD email@example.com|
|Contact: Matthew Lapointe, MS 617-758-5506 firstname.lastname@example.org|