The Effect of a Sub-symptom Threshold Aerobic Exercise Program on Recovery in Concussed Athletes

NCT03865433 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-08-20

No results posted yet for this study

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

Interventions

OTHER

Aerobic Exercise

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

OTHER

Placebo/Stretching

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

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER
  • Rocky Mountain University of Health Professions

    lead OTHER

Principal Investigators

  • Emily Kosderka, MS · Rocky Mountain University of Health Professions

  • Douglas Powell, PhD · Rocky Mountain University of Health Professions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2020-07-01
Completion
2020-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03865433 on ClinicalTrials.gov