Clinical Trial: The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury

Brief Summary: The study is a "proof-of-principle" project to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). The study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor [BDNF] concentration).

Detailed Summary: This is a "proof-of-principle" project for human subjects to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). This study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor [BDNF] concentration). This project will also lay the foundation for understanding the relationship between exercise and BDNF in the area of mTBI neurorecovery, thereby allowing future studies to develop best-practice methods for implementing exercise interventions as a treatment option for brain injuries.
Sponsor: University of Florida

Current Primary Outcome:

  • Change in Symptom Score on the Sport Concussion Assessment Tool (SCAT3) [ Time Frame: Baseline and up to day 8 ]
    Obtained from the 22-item symptom evaluation included in the Sport Concussion Assessment Tool (SCAT3). The participant's present experience of each symptom is rated on a likert scale from 0 (none) to 6 (severe). The symptom score represents how many symptoms the participant endorses experiencing at a level greater than 0 (maximum 22 points).
  • Change in Symptom Severity on the Sport Concussion Assessment Tool (SCAT3) [ Time Frame: Baseline and up to day 8 ]
    Symptom evaluation included in the Sport Concussion Assessment Tool (SCAT3). The participant's present experience of each symptom is rated on a likert scale from 0 (none) to 6 (severe). The symptom severity represents the total summed severity ratings for all symptoms (maximum 132 points).
  • Change in sleep quality [ Time Frame: Baseline and up to day 8 ]
    Obtained from the Medical Outcomes Sleep Scale (MOS). This measure has 12 items and asks the participant to rate different aspects of their sleep experiences and sleep quality. The first two questions inquire about sleep times and the remaining questions utilize a likert scale ranging from 1 (all of the time) to 6 (none of the time). Some items are reverse scored and the scale yields several subscale measures, so scoring rules depend on the specific subscale.
  • Change in postural stability [ Time Frame: Baseline and up to day 8 ]
    The Balance Error Scoring System (BESS) will be used to measure postural stab

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change in functional neuroimaging activation [ Time Frame: Baseline and up to day 8 ]
      Functional resting state sequences will be performed on the Phillips 3 tesla magnetic resonance (MR) research scanner.
    • Change in Symptom Score on the Sport Concussion Assessment Tool (SCAT3) [ Time Frame: Baseline and up to day 70 ]
      Obtained from the 22-item symptom evaluation included in the Sport Concussion Assessment Tool (SCAT3). The participant's present experience of each symptom is rated on a likert scale from 0 (none) to 6 (severe). The symptom score represents how many symptoms the participant endorses experiencing at a level greater than 0 (maximum 22 points).
    • Change in Symptom Severity on the Sport Concussion Assessment Tool (SCAT3) [ Time Frame: Baseline and up to day 70 ]
      Symptom evaluation included in the Sport Concussion Assessment Tool (SCAT3). The participant's present experience of each symptom is rated on a likert scale from 0 (none) to 6 (severe). The symptom severity represents the total summed severity ratings for all symptoms (maximum 132 points).
    • Change in sleep quality [ Time Frame: Baseline and up to day 70 ]
      Obtained from the Medical Outcomes Sleep Scale (MOS). This measure has 12 items and asks the participant to rate different aspects of their sleep experiences and sleep quality. The first two questions inquire about sleep times and the remaining questions utilize a likert scale ranging from 1 (all of the time) to 6 (none of the time).
    • Change in postural stability [ Time Frame: Baseline and up to day 70 ]
      The Balance Error Scoring System (BESS) will be used to measure postural stability, which is sensitive to deficits in balance following mild head injury. A modified version of (SCAT3) will be used. It includes three different stances, double leg, single leg, and tandem stance. A point is added for committing an error during the test interval and if the participant is unable to maintain his or her balance for more than 5 seconds, the trial is discontinued and maximum points are awarded. The total score ranges from 0 (better postural stability) to 30 (worse postural stability).
    • Change in depression symptoms [ Time Frame: Baseline and up to day 70 ]
      Measured by the Beck Depression Inventory, 2nd Edition (BDI-II), which is a self-report questionnaire with 21 multiple choice items. The total score ranges from 0 to 63 with higher numbers indicating greater severity of depression symptoms.
    • Change in anxiety symptoms [ Time Frame: Baseline and up to day 70 ]
      Measured by the State Trait Anxiety Inventory (STAI), which is a self-report questionnaire with 40 questions on a 4-point likert scale. The STAI measures two types of anxiety - state and trait scores. Higher scores are positively correlated with higher levels of anxiety.


    Original Secondary Outcome: Same as current

    Information By: University of Florida

    Dates:
    Date Received: October 23, 2014
    Date Started: February 2015
    Date Completion: May 2018
    Last Updated: December 13, 2016
    Last Verified: December 2016