Status:
UNKNOWN
Sub-maximal Exercise Prescription in Adolescents With Physiological Post-concussion Disorder
Lead Sponsor:
Sport Injury Prevention Research Centre
Collaborating Sponsors:
University of Manitoba
Conditions:
Physiological Post-Concussion Disorder
Post-Concussion Syndrome
Eligibility:
All Genders
13-19 years
Phase:
NA
Brief Summary
Although the vast majority of individuals sustaining a sport-related concussion (SRC) will receive medical clearance to return to sport within 7-10 days, approximately 30% of children and adolescents ...
Detailed Description
Research statement:This study is a multi-centre RCT. The purpose of the RCT is to evaluate the efficacy of a moderate intensity (80% symptom threshold heart rate (HR), Borg Rating of Perceived exertio...
Eligibility Criteria
Inclusion
- Age 13-19 years
- Physician diagnosed sports-related concussion, defined according to the 5th International Consensus Statement on Concussion in Sport (McCrory et al., 2017) as an injury caused by transmission of biomechanical forces to the brain leading to clinical symptoms affecting multiple domains of physical, cognitive, sleep, and neurobehavioral functioning (McCrory et al., 2017);
- persistent symptoms at 10-30 days post-concussion;
- a post-concussion symptom scale score greater than 5 for males and 8 for females (these are above the typically reported values for non-concussed athletes);
- self reported difficulties with exertion and/or a graded aerobic treadmill test demonstrating isolated Physiological Post Concussion Disorder;
- participant and parent/guardian informed consent;
- Participant must be able to reach a heart rate greater than 100 but less than 210 bpm, during and throughout the onset of exercise (to ensure their sub-symptom threshold is still above resting norms);
- Voluntary consent to wear an Actigraph (wGT3X-BT) accelerometer monitor for a minimum of 2 weeks and the provided Polar HR monitor during daily exercise.
Exclusion
- clinical evidence of vestibulo-ocular dysfunction (Ellis, et al., 2015; 2017);
- clinical evidence of cervical spine soft tissue injury (Schneider et al., 2014);
- past medical history of International Classification of Diseases-3 beta version migraine headaches;
- undergoing active medical treatment for a psychiatric disorder (e.g. on medication for depression);
- contraindication to exercise testing (traumatic abnormality on neuroimaging studies, co-existing cardiac, respiratory or orthopedic contraindication to exercise testing, pregnancy);
- exercise intolerance reached before 100 bpm, or after 210 bpm (age predicted maximum heart rate) on graded exercise test;
- subjects refusal to wear Actigraph and Polar HR monitor;
- subjects resting HR above 99bpm or blood pressure greater than 144/94.
Key Trial Info
Start Date :
December 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2019
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03367507
Start Date
December 10 2017
End Date
November 1 2019
Last Update
December 8 2017
Active Locations (2)
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1
University of Calgary
Calgary, Alberta, Canada
2
Pan Am Sports Medicine Clinic
Winnipeg, Manitoba, Canada