Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion
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|ClinicalTrials.gov Identifier: NCT02710123|
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Injury Concussion||Other: Sub-Threshold exercise prescription Other: Structured stretching prescription||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 31, 2018|
|Actual Study Completion Date :||June 1, 2018|
Experimental: Aerobic Exercise
Participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during the Buffalo Concussion Treadmill Test (BCTT). The script will ask the participant to exercise one a day for 20 minutes at 80% of HRT. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Sub-Threshold exercise prescription
Other: Sub-Threshold exercise prescription
Participants will be given a prescription to exercise at 80% of their threshold HR for symptom exacerbation. HR Threshold will be monitored weekly and exercise level increased accordingly.
Placebo Comparator: Stretching Exercise
Participants will receive a prescription for stretching exercises that they will be asked to do daily. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Structured stretching exercise prescription.
Other: Structured stretching prescription
Participants will be given a prescription for daily stretching lasting approximately 20 minutes.
- Time (in days) to recovery [ Time Frame: 2 to 180 days ]Time (in days) to recovery (Recovery is asymptomatic+able to exercise to exhaustion without symptom exacerbation+judged recovered by MD with structured physical exam.)
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): NCT02710123
|United States, New York|
|University at Buffalo|
|Buffalo, New York, United States, 14214|
|Principal Investigator:||John Leddy, MD||University at Buffalo|