Recruiting

Aerobic Exercise

Sponsor:

Rocky Mountain University of Health Professions

Code:

NCT03865433

Conditions

Concussion, Mild

Rehabilitation

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

Aerobic Exercise

Placebo/Stretching

Study Details

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.

Conditions

Concussion, Mild

Rehabilitation

Study ID

NCT03865433

Start date

Feb 27, 2019

Status verified date

Aug, 2019

Completion date

Jul 1, 2020

Anticipated

Primary completion date

Jul 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Aerobic Exercise

Sub-symptom threshold aerobic exercise at a dose of 30 minutes per day, five days per week.

Placebo/Stretching

A detailed, progressive stretching program to be performed for approximately 20-30 minutes per day, five days per week

Primary outcome measure

  • Time to full clinical recovery [ Time Frame: 0-45 days ]

Central Contacts and Locations

Central contacts

James Chesnutt, MD

503-494-9992chesnutt@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97219

Contacts

Jim Chesnutt, MD

503-494-1950chesnutt@ohsu.edu

Principal Investigator:

Jim Chesnutt, MD

More Information

Sponsor

Rocky Mountain University of Health Professions

Last update posted

Aug 20, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rocky Mountain University of Health Professions on 2019-08-20.