The Effect of a Sub-symptom Threshold Aerobic Exercise Program on Recovery in Concussed Athletes
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|ClinicalTrials.gov Identifier: NCT03865433|
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
The purpose of this randomized controlled trial is to examine whether systematic sub-threshold exercise is effective in improving recovery time in athletes after sport related concussion (SRC) compared to those who participate in a placebo/stretching protocol. subjects will be randomized into either an Exercise group or a Placebo/stretching group. subjects in the Exercise group will participate in an individualized exercise program supervised by their athletic trainer while the Placebo/stretching group will engage in a standardized stretching routine supervised by their athletic trainer throughout the duration of their recovery.
Hypothesis 1: subjects in the aerobic Exercise group will require fewer days to recover from SRC than those who follow a placebo/stretching protocol.
Hypothesis 2: heart rate threshold (HRt) achieved on the graded treadmill test will be associated with days to recovery (i.e., the lower the HRt, the longer the time to recovery).
Hypothesis 3: Vestibular Ocular Motor Screen (VOMS) performance will be indicative of time to clinical recovery from concussion as evidenced by a strong correlation between VOMS score and days to clinical recovery.
Hypothesis 4: Sub-threshold aerobic exercise will facilitate improvement in VOMS post-concussion.
Hypothesis 5: subjects in the aerobic exercise group will demonstrate greater dynamic stability as evidenced by greater reach in each of the 3 primary directions (anterior, posterior medial and posterior lateral) for their right and left lower extremity.
|Condition or disease||Intervention/treatment||Phase|
|Concussion, Mild Rehabilitation||Other: Aerobic Exercise Other: Placebo/Stretching||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomly assigned to one of two groups: the intervention group or the placebo/control group|
|Masking:||Single (Care Provider)|
|Masking Description:||Study physicians will be blinded to group allocation|
|Official Title:||The Effect of a Sub-symptom Threshold Aerobic Exercise Program on Recovery in Concussed Athletes|
|Actual Study Start Date :||February 27, 2019|
|Estimated Primary Completion Date :||December 25, 2019|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: Exercise Group
Intervention: aerobic exercise Subjects in the exercise group will be prescribed exercise at a target heart rate (THR) of approximately 80% of the achieved heart rate during the Buffalo Concussion Treadmill Test (BCTT). They will be given this prescription in writing to provide to their athletic trainer. Subjects will complete 30 minutes of daily exercise (including 5 minutes of warm up and 5 minutes of cool down) on an exercise bike or walking and supervised by an athletic trainer. This program may be modified by increasing heart rate threshold 5-10 beats per minute per week by the athletic trainer as the heart rate for symptom exacerbation increases.
Other: Aerobic Exercise
Sub-symptom threshold aerobic exercise at a dose of 30 minutes per day, five days per week.
Placebo Comparator: Placebo/Stretching
Intrvention: stretching program Subjects assigned to the Stretching/Placebo group will be given a stretching protocol and instructions to report to their athletic trainer on a daily basis as soon as possible. . Subjects will then complete a 15-25 minute stretching program under supervision by the athletic trainer or other designated research personnel. The stretching protocol will be progressive and will change weekly as subjects continue their recovery.
A detailed, progressive stretching program to be performed for approximately 20-30 minutes per day, five days per week
- Time to full clinical recovery [ Time Frame: 0-45 days ]days between injury and return to play
- Heart rate [ Time Frame: Achieved HR measured and recorded on first Buffalo Concussion Treadmill Test (Week 0-baseline)-6 weeks ]Relationship between achieved heart rate on the Buffalo Concussion Test (Monitored using a Polar heart rate monitor) and recovery time.
- Vestibular Ocular Motor Screening (VOMS) [ Time Frame: Recorded on first visit (Week 0-baseline)-6 weeks ]Improved vestibular and oculo motor function with the treatment, as reflected by lower scores
- Y Balance Test (YBT) score [ Time Frame: Administered and recorded on the first visit (Week 0-baseline)-6 weeks ]Improved balance as indicated by increased reach scores with the treatment
- Concussion symptom burden [ Time Frame: Week 0 (baseline)- 6 weeks ]Improvement on The Post-Concussion Symptom Scale with the treatment, as indicated by lower scores
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): NCT03865433
|Contact: Rachel Coel, MD, PhD||808-691-4449||rcoel@Queens.org|
|Contact: Rebecca Ohta||rohta@Queens.org|
|United States, Hawaii|
|The Queen's Medical Center||Recruiting|
|Honolulu, Hawaii, United States, 96813|
|Contact: Rachel Coel, MD, PhD 808-691-4449 rcoel@Queens.org|
|Sub-Investigator: Emily M Kosderka, MS|
|Sub-Investigator: Douglas W Powell, PhD|
|Sub-Investigator: James Chesnutt, MD|
|Principal Investigator: Rachel Coel, MD, PhD|
|Sub-Investigator: Nathan Murata, PhD|
|United States, Oregon|
|Oregon Health and Science University||Not yet recruiting|
|Portland, Oregon, United States, 97219|
|Contact: Jim Chesnutt, MD 503-494-1950 firstname.lastname@example.org|
|Principal Investigator: Jim Chesnutt, MD|
|Sub-Investigator: Emily Kosderka, MS|
|Sub-Investigator: Doug Powell, PhD|
|Principal Investigator:||Emily Kosderka, MS||Rocky Mountain University of Health Professions|
|Study Chair:||Douglas Powell, PhD||Rocky Mountain University of Health Professions|