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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
Sponsor:
Collaborators:
Oregon Health and Science University
Queens Medical Center
Information provided by (Responsible Party):
Emily Kosderka, Rocky Mountain University of Health Professions

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Placebo/Stretching
A detailed, progressive stretching program to be performed for approximately 20-30 minutes per day, five days per week




Primary Outcome Measures :
  1. Time to full clinical recovery [ Time Frame: 0-45 days ]
    days between injury and return to play


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. are aged 13-17, years and a high school student-athlete who attends school where an athletic trainer can supervise the exercise protocol;
  2. have sustained a concussion within 2-7 days of clinic presentation and diagnosed by a study physician;
  3. demonstrate symptom exacerbation during a graded treadmill exercise test and cannot complete the test;
  4. are currently participating in a school or club sport;
  5. are English speaking and capable of giving assent

Exclusion Criteria:

  1. have a reported history of neurological condition or disorder including but not limited to brain surgery, special education, seizure disorder, speech pathology, previous diagnosis of Post-Concussion Syndrome (PCS),
  2. are unwilling to exercise,
  3. have focal neurologic deficit that would represent risk for walking/running on treadmill,
  4. exhibit an inability to exercise due to injury, known heart disease, or increased cardiac risk,
  5. have experienced more than 3 previous concussions,
  6. have suffered a substantial comorbidity (eg,cervical injury),
  7. currently taking β-blockers, calcium channel blockers, or prophylactic headache medications (e.g., amitriptyline, topiramate), or
  8. have a resting blood pressure of > 140/90.
  9. If the potential participant or parent/guardian is unable to fully understand the study protocol or study risks due to injury or developmental delay, the potential participant will be excluded from the study.

Information from the National Library of Medicine

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


Contacts
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Contact: Rachel Coel, MD, PhD 808-691-4449 rcoel@Queens.org
Contact: Rebecca Ohta rohta@Queens.org

Locations
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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    chesnutt@ohsu.edu   
Principal Investigator: Jim Chesnutt, MD         
Sub-Investigator: Emily Kosderka, MS         
Sub-Investigator: Doug Powell, PhD         
Sponsors and Collaborators
Rocky Mountain University of Health Professions
Oregon Health and Science University
Queens Medical Center
Investigators
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Principal Investigator: Emily Kosderka, MS Rocky Mountain University of Health Professions
Study Chair: Douglas Powell, PhD Rocky Mountain University of Health Professions

Publications:

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Responsible Party: Emily Kosderka, Principle Investigator, Rocky Mountain University of Health Professions
ClinicalTrials.gov Identifier: NCT03865433     History of Changes
Other Study ID Numbers: ConcussionRecovery2019
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating