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The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276079
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
Clinical & Translational Science Institute
American Psychological Foundation
American Psychological Association (APA)
Information provided by (Responsible Party):
University of Florida

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).

Condition or disease Intervention/treatment Phase
Brain Concussion Behavioral: Aerobic Exercise Behavioral: Non-Aerobic Exercise Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury
Actual Study Start Date : February 17, 2015
Actual Primary Completion Date : December 22, 2016
Actual Study Completion Date : December 22, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mTBI Aerobic Exercise Group
Participants are two-three weeks post-mild traumatic brain injury are randomized to receive a daily aerobic exercise intervention lasting 1-week.
Behavioral: Aerobic Exercise
Aerobic exercise will consist of riding a stationary bicycle at moderate intensity for 2 consecutive, 20-minute periods with a 5-minute break in between. Moderate intensity is defined as maintaining 65-75% of estimated maximum heart rate based on the calculation (HRmax = 208 - 0.7 × age).

Experimental: mTBI Non-Aerobic Exercise Group
Participants are two-three weeks post-mild traumatic brain injury are randomized to receive a daily non-aerobic exercise intervention lasting 1-week.
Behavioral: Non-Aerobic Exercise
Non-Aerobic exercise will consist of very low-intensity movements including static stretching and toning exercises.Participants will complete 2 consecutive, 20-minute periods with a 5-minute break in between, mirroring the aerobic exercise condition. Heart rate will be monitored by research staff to ensure that it remains below 50% of estimated maximum heart rate.

No Intervention: Non-injured Reference Group
Non-injured, healthy participants will serve as a reference group for functional outcome measures.



Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. Change in postural stability [ Time Frame: Baseline and up to day 8 ]
    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).

  5. Change in verbal learning and memory [ Time Frame: Baseline and up to day 8 ]
    Measured by the California Verbal Learning Test, 2nd Edition (CVLT-II). This test measures word recall and assesses the following skills: immediate recall, short delay free recall, short delay cued recall, long delay free recall, long delay cued recall, and long delay recognition.

  6. Change in auditory-linguistic memory [ Time Frame: Baseline and up to day 8 ]
    Measured by the Wechsler Memory Scale, 3rd Edition (WMS-III), Logical Memory subtests. Two stories are read to participants and then they are asked to freely recall items after a short and a long delay. A recognition trial is administered following the long delay.

  7. Change in word-fluency [ Time Frame: Baseline and up to day 8 ]
    Measured by the Controlled Oral Word Association (COWA). Participants are asked to say as many words beginning with a specified letter as they can in a one minute time period. Three trials with different letters are administered.

  8. Change in semantic fluency [ Time Frame: Baseline and up to day 8 ]
    Measured by the Verbal Fluency Test - Categories. Participants are asked to say as many items belonging to a specified semantic category as they can in a one minute time period.

  9. Change in psychomotor/executive functioning [ Time Frame: Baseline and up to day 8 ]
    Measured by the Delis-Kaplan Executive Functioning System (D-KEFS), Trail Making Test. The test consists of five different conditions where participants are asked to draw trails according to specified rules.

  10. Change in problem solving and abstract reasoning [ Time Frame: Baseline and up to day 8 ]
    Measured by the Wisconsin Card Sorting Test (WCST). Initially, a number of stimulus cards are presented to the participant. The participant is told to match the cards, but not how to match; however, he or she is told whether a particular match is right or wrong. A total of 128 cards are played.

  11. Change in attention [ Time Frame: Baseline and up to day 8 ]
    Measured by the Wechsler Adult Intelligence Scale, 3rd Edition (WAIS-III), Digit Span subtest. Participants are asked to repeat digit strings that are verbally administered exactly as they hear them (digits forward) or to repeat them backwards (digits backward).

  12. Change in processing speed [ Time Frame: Baseline and up to day 8 ]
    Measured by the Wechsler Adult Intelligence Scale, 3rd Edition (WAIS-III), Digit Symbol-Coding subtest. Participants are given three minutes to draw symbols as quickly and as accurately as possible according to a key code.

  13. Change in visual memory [ Time Frame: Baseline and up to day 8 ]
    Measured by the Wechsler Memory Scale, 3rd Edition (WMS-III), Visual Reproduction subtest. Participants are asked to draw abstract figures from memory at different time intervals. The subtest assesses the following visual memory skills: immediate free recall, long delayed free recall and a long delayed recognition.

  14. Change in sustained and selective attention [ Time Frame: Baseline and up to day 8 ]
    Measured by the Ruff 2 & 7 Selective Attention Test. The test consists of a series of 20 trials of a visual search and cancellation task. The participant detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test.

  15. Change in working memory and attention [ Time Frame: Baseline and up to day 8 ]
    Measured by the Paced Auditory Serial Addition Test (PASAT). Participants are read a series of numbers at specified time intervals. The participants are instructed to add the number to the preceding number and continue adding them together until the end of the trial. Four trials with 50 items each are administered with a 30 second break in between.

  16. Change in depression symptoms [ Time Frame: Baseline and up to day 8 ]
    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.

  17. Change in anxiety symptoms [ Time Frame: Baseline and up to day 8 ]
    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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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.


Other Outcome Measures:
  1. Change in aerobic fitness [ Time Frame: Baseline and up to day 8 ]
    Measured by the 3-Minute Step Test, which provides an estimate of aerobic fitness. Participants step up and down continuously on a 12-inch step for 3 minutes and the time it takes for their heart rate to return to baseline is recorded.

  2. Change in body weight [ Time Frame: Baseline and up to day 8 ]
    Body weight measured in kilograms.

  3. Minutes of physical activity outside of exercise program [ Time Frame: Day 7 of exercise program ]
    Average number of minutes the participant spent engaging in physical activity outside of the exercise sessions during the one-week exercise program. This will be measured by a digital fitness monitor that will be worn 24 hours per day during the 7 day exercise program.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Mild traumatic brain injury (mTBI) group:

Inclusion Criteria:

  • Meet criteria for mTBI as set forth by the American Congress of Rehabilitation Medicine
  • mTBI was sustained 14-25 days before beginning the exercise intervention

Exclusion Criteria:

  • comorbid orthopaedic injury that inhibits movement
  • history of serious psychiatric disturbance with hospitalization,
  • prior history of neurologic disease,
  • current or past history of substance abuse disorder,
  • diabetes
  • previous history of moderate or severe head injury,
  • neurological disorder unrelated to TBI (e.g., seizure disorder)
  • physician recommendations against exercise
  • non-English speakers

Non-injured Group:

Inclusion Criteria:

- Gainesville, Florida community member

Exclusion Criteria:

  • History of mTBI or other brain injury in the past year
  • comorbid orthopaedic injury that inhibits movement
  • history of serious psychiatric disturbance with hospitalization,
  • prior history of neurologic disease,
  • current or past history of substance abuse disorder,
  • diabetes
  • previous history of moderate or severe head injury,
  • neurological disorder unrelated to TBI (e.g., seizure disorder)
  • physician recommendations against exercise
  • non-English speakers

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): NCT02276079


Locations
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United States, Florida
University of Florida Health Science Center
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Clinical & Translational Science Institute
American Psychological Foundation
American Psychological Association (APA)
Investigators
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Principal Investigator: Russell M. Bauer, Ph.D. University of Florida
Study Director: Aliyah R. Snyder, M.S. University of Florida
Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02276079    
Other Study ID Numbers: IRB201400882
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Keywords provided by University of Florida:
Mild Traumatic Brain Injury
Aerobic Exercise
Brain-Derived Neurotrophic Factor
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating