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NCT Number: NCT05786729

Aerobic Exercise After Traumatic Brain Injury

The purpose of this study is to examine the effects of individualized aerobic exercise regimen on recovery after traumatic brain injury (TBI).Investigators will determine if exercise facilitates recovery by facilitating neuroplasticity and decreasing neuroinflammation.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre for Neuro Skills

Bakersfield, California, 93313, United States

About this study

Exercise-based therapies can promote recovery of function and are easily implemented in the clinical rehabilitation setting. This study will determine if exercise facilitates recovery by improving markers of neuroplasticity and decreasing neuroinflammatory responses. The investigators will also determine if variations in genes involved in neuroplasticity, and inflammation influence the responsiveness to exercise and rehabilitation. Recovery will be determined by assessing cognitive function, life quality and balance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants will provide informed consent and have to comply with the procedures of the study.
  • Age will range from 18 to 60 years.
  • Except for the non-injured control group, subjects will be required to have experienced TBI.
  • All participants should be fluent in English or Spanish.
  • All participants should have the ability to comply with the research protocol.
  • Capable of exercising in aerobic exercise equipment (with or without trunk support).
  • Able to walk independently with or without a device

Exclusion criteria

  • Current diagnosis of degenerative neurological disease.
  • A history of cerebral vascular accidents.
  • A history of major psychosis as defined by DSM-IV.
  • Subjects receiving physical therapy in a location that is not CNS.
  • Pregnancy.
  • A history of previous TBI requiring hospitalization.
  • Inability to cooperate
  • Orthopedic impairment that compromises exercise performance
  • Any cardiovascular or respiratory condition that jeopardizes patient health during exercise.

Treatment and study plan

Aerobic Exercise (AER)

Other

Aerobic exercise will be performed by utilizing aerobic exercise equipment 3 times per week.

rehabilitation

Other

Rehabilitative program is focused on completion of activities of daily living, initiation, appropriate behavior and community integration for five days per week at the Centre for Neuro Skills.

Primary outcomes

  1. Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline

    Time frame: Baseline

    CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.

  2. Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 4

    Time frame: Week 4

    CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.

  3. Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 8

    Time frame: Week 8

    CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.

  4. Aerobic Exercise Induced Changes in Cardio Pulmonary (CPET) at Week 12

    Time frame: Week 12

    CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.

Secondary outcomes

  1. Aerobic Exercise Induced Changes in Cognitive Function at baseline

    Time frame: Baseline

    Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.

  2. Aerobic Exercise Induced Changes in Cognitive Function at Week 4

    Time frame: Week 4

    Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.

  3. Aerobic Exercise Induced Changes in Cognitive Function at Week 8

    Time frame: Week 8

    Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.

  4. Aerobic Exercise Induced Changes in Cognitive Function at Week 12

    Time frame: Week 12

    Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.

  5. Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at baseline

    Time frame: Baseline

    The California Verbal Learning Test (CVLT II) is a verbal memory cognitive assessment. It assesses repetition learning, serial position effects, semantic organization, intrusions, and proactive interference. CVLT II scores have a mean of 0 and a SD of 1. The range of scores is +5 to -5 reported in increments of .5.

  6. Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 4

    Time frame: Week 4

    The California Verbal Learning Test (CVLT II) is a verbal memory cognitive assessment. It assesses repetition learning, serial position effects, semantic organization, intrusions, and proactive interference. CVLT II scores have a mean of 0 and a SD of 1. The range of scores is +5 to -5 reported in increments of .5.

  7. Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 8

    Time frame: Week 8

    The California Verbal Learning Test (CVLT II) is a verbal memory cognitive assessment. It assesses repetition learning, serial position effects, semantic organization, intrusions, and proactive interference. CVLT II scores have a mean of 0 and a SD of 1. The range of scores is +5 to -5 reported in increments of .5.

  8. Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 12

    Time frame: Week 12

    The California Verbal Learning Test (CVLT II) is a verbal memory cognitive assessment. It assesses repetition learning, serial position effects, semantic organization, intrusions, and proactive interference. CVLT II scores have a mean of 0 and a SD of 1. The range of scores is +5 to -5 reported in increments of .5.

  9. Quality of Life Measured by the NeuroQOL at baseline

    Time frame: Baseline

    The NeuroQOL assesses quality of life in the domains of Physical Domain, Mental Domain, Cognitive Domain, and Social Domain. Items are scored on a 5-point scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. T-score are used, mean of 50 and SD of 10

  10. Quality of Life Measured by the NeuroQOL at Week 4

    Time frame: Week 4

    The NeuroQOL assesses quality of life in the domains of Physical Domain, Mental Domain, Cognitive Domain, and Social Domain. Items are scored on a 5-point scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. T-score are used, mean of 50 and SD of 10

  11. Quality of Life Measured by the NeuroQOL at Week 8

    Time frame: Week 8

    The NeuroQOL assesses quality of life in the domains of Physical Domain, Mental Domain, Cognitive Domain, and Social Domain. Items are scored on a 5-point scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. T-score are used, mean of 50 and SD of 10

  12. Quality of Life Measured by the NeuroQOL at Week 12

    Time frame: Week 12

    The NeuroQOL assesses quality of life in the domains of Physical Domain, Mental Domain, Cognitive Domain, and Social Domain. Items are scored on a 5-point scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. T-score are used, mean of 50 and SD of 10

  13. Depression measured by the Beck Depression Inventory-II at baseline

    Time frame: Baseline

    The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.

  14. Depression measured by the Beck Depression Inventory-II at Week 4

    Time frame: Week 4

    The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.

  15. Depression measured by the Beck Depression Inventory-II at Week 8

    Time frame: Week 8

    The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.

  16. Depression measured by the Beck Depression Inventory-II at Week 12

    Time frame: Week 12

    The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.

  17. Visual Search/ Processing Speed measured by Trail Making Test (TMT) at baseline

    Time frame: Baseline

    The Trail Making Test (TMT) provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task.

  18. Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 4

    Time frame: Week 4

    The Trail Making Test (TMT) provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task.

  19. Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 8

    Time frame: Week 8

    The Trail Making Test (TMT) provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task.

  20. Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 12

    Time frame: Week 12

    The Trail Making Test (TMT) provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task.

  21. Sleepiness will be measured by the Epworth Sleepiness Scale at baseline

    Time frame: Baseline

    The Epworth Sleepiness Scale is used to measure a patient's sleepiness. The test is a list of eight situations in which the patient rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is based on a scale of 0 to 24. The scale estimates whether you are experiencing excessive sleepiness.

  22. Sleepiness will be measured by the Epworth Sleepiness Scale at Week 4

    Time frame: Week 4

    The Epworth Sleepiness Scale is used to measure a patient's sleepiness. The test is a list of eight situations in which the patient rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is based on a scale of 0 to 24. The scale estimates whether you are experiencing excessive sleepiness.

  23. Sleepiness will be measured by the Epworth Sleepiness Scale at Week 8

    Time frame: Week 8

    The Epworth Sleepiness Scale is used to measure a patient's sleepiness. The test is a list of eight situations in which the patient rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is based on a scale of 0 to 24. The scale estimates whether you are experiencing excessive sleepiness.

  24. Sleepiness will be measured by the Epworth Sleepiness Scale at Week 12

    Time frame: Week 12

    The Epworth Sleepiness Scale is used to measure a patient's sleepiness. The test is a list of eight situations in which the patient rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is based on a scale of 0 to 24. The scale estimates whether you are experiencing excessive sleepiness.

  25. Vestibular function will be measured by the Berg Balance Test at baseline

    Time frame: Baseline

    The Berg Balance Scale is used to determine vestibular function through a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

  26. Vestibular function will be measured by the Berg Balance Test at Week 4

    Time frame: Week 4

    The Berg Balance Scale is used to determine vestibular function through a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

  27. Vestibular function will be measured by the Berg Balance Test at Week 8

    Time frame: Week 8

    The Berg Balance Scale is used to determine vestibular function through a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

  28. Vestibular function will be measured by the Berg Balance Test at Week 12

    Time frame: Week 12

    The Berg Balance Scale is used to determine vestibular function through a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

  29. Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at baseline

    Time frame: Baseline

    The 6 Minute Walk Test (6MWT) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. A lower score (reflecting less distance covered in 6 minutes) indicates worse function. An increase in the distance walked indicates improvement in basic mobility.

  30. Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 4

    Time frame: Week 4

    The 6 Minute Walk Test (6MWT) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. A lower score (reflecting less distance covered in 6 minutes) indicates worse function. An increase in the distance walked indicates improvement in basic mobility.

  31. Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 8

    Time frame: Week 8

    The 6 Minute Walk Test (6MWT) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. A lower score (reflecting less distance covered in 6 minutes) indicates worse function. An increase in the distance walked indicates improvement in basic mobility.

  32. Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 12

    Time frame: Week 12

    The 6 Minute Walk Test (6MWT) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. A lower score (reflecting less distance covered in 6 minutes) indicates worse function. An increase in the distance walked indicates improvement in basic mobility.

  33. Evaluation of Inflammatory Biomarkers at Baseline

    Time frame: Baseline

    Biomarkers IL10, IL12, IL-1β, IL-4 , IL-5, IL-6, IL-7, IL-8, TNFα, will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  34. Evaluation of Inflammatory Biomarkers at Week 4

    Time frame: Week 4

    Biomarkers IL10, IL12, IL-1β, IL-4 , IL-5, IL-6, IL-7, IL-8, TNFα, will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  35. Evaluation of Inflammatory Biomarkers at Week 8

    Time frame: Week 8

    Biomarkers IL10, IL12, IL-1β, IL-4 , IL-5, IL-6, IL-7, IL-8, TNFα, will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  36. Evaluation of Inflammatory Biomarkers at Week 12

    Time frame: Week 12

    Biomarkers IL10, IL12, IL-1β, IL-4 , IL-5, IL-6, IL-7, IL-8, TNFα, will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  37. Evaluation of Neuroplasticity, Stress Biomarkers at Baseline

    Time frame: Baseline

    Biomarkers BDNF, GH, ACTH, Cortisol, Melatonin, VEGF will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  38. Evaluation of Neuroplasticity, Stress Biomarkers at Week 4

    Time frame: Week 4

    Biomarkers BDNF, GH, ACTH, Cortisol, Melatonin, VEGF will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  39. Evaluation of Neuroplasticity, Stress Biomarkers at Week 8

    Time frame: Week 8

    Biomarkers BDNF, GH, ACTH, Cortisol, Melatonin, VEGF will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  40. Evaluation of Neuroplasticity, Stress Biomarkers at Week 12

    Time frame: Week 12

    Biomarkers BDNF, GH, ACTH, Cortisol, Melatonin, VEGF will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  41. Evaluation of Neurodegeneration Biomarkers at Baseline

    Time frame: Baseline

    Biomarkers sCAM1, vCAM-1, sFAS will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  42. Evaluation of Neurodegeneration Biomarkers at Week 4

    Time frame: Week 4

    Biomarkers sCAM1, vCAM-1, sFAS will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  43. Evaluation of Neurodegeneration Biomarkers at Week 8

    Time frame: Week 8

    Biomarkers sCAM1, vCAM-1, sFAS will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  44. Evaluation of Neurodegeneration Biomarkers at Week 12

    Time frame: Week 12

    Biomarkers sCAM1, vCAM-1, sFAS will be measured in blood serum before and after a 30 minute aerobic activity. Results will be reported as change in levels.

  45. BDNF / Val66Met at baseline

    Time frame: Baseline

    Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.

  46. BDNF / Val66Met at Week 4

    Time frame: Week 4

    Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.

  47. BDNF / Val66Met at Week 8

    Time frame: Week 8

    Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.

  48. BDNF / Val66Met at Week 12

    Time frame: Week 12

    Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.

  49. IL-1β / rs16944 at baseline

    Time frame: Baseline

    Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.

  50. IL-1β / rs16944 at Week 4

    Time frame: Week 4

    Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.

  51. IL-1β / rs16944 at Week 8

    Time frame: Week 8

    Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.

  52. IL-1β / rs16944 at Week 12

    Time frame: Week 12

    Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.

  53. TrkB at baseline

    Time frame: Baseline

    Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.

  54. TrkB at Week 4

    Time frame: Week 4

    Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.

  55. TrkB at Week 8

    Time frame: Week 8

    Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.

  56. TrkB at Week 12

    Time frame: Week 12

    Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.

  57. COMT / VAll58Met at baseline

    Time frame: Baseline

    Evaluation of genetic material COMT / VAll58Met will be measured in a saliva sample. Results will be reported as% difference from the general population.

  58. COMT / VAll58Met at Week 4

    Time frame: Week 4

    Evaluation of genetic material COMT / VAll58Met will be measured in a saliva sample. Results will be reported as% difference from the general population.

  59. COMT / VAll58Met at Week 8

    Time frame: Week 8

    Evaluation of genetic material COMT / VAll58Met will be measured in a saliva sample. Results will be reported as% difference from the general population.

  60. COMT / VAll58Met at Week 12

    Time frame: Week 12

    Evaluation of genetic material COMT / VAll58Met ewill be measured in a saliva sample. Results will be reported as% difference from the general population.

  61. DRD2 / A to T & A to G at baseline

    Time frame: Baseline

    Evaluation of genetic material DRD2 / A to T & A to G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  62. DRD2 / A to T & A to G at Week 4

    Time frame: Week 4

    Evaluation of genetic material DRD2 / A to T & A to G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  63. DRD2 / A to T & A to G at Week 8

    Time frame: Week 8

    Evaluation of genetic material DRD2 / A to T & A to G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  64. DRD2 / A to T & A to G at Week 12

    Time frame: Week 12

    Evaluation of genetic material DRD2 / A to T & A to G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  65. ANKKI / TAQIA at baseline

    Time frame: Baseline

    Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.

  66. ANKKI / TAQIA at Week 4

    Time frame: Week 4

    Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.

  67. ANKKI / TAQIA at Week 8

    Time frame: Week 8

    Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.

  68. ANKKI / TAQIA at Week 12

    Time frame: Week 12

    Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.

  69. PPPIRIB / C to T at baseline

    Time frame: Baseline

    Evaluation of genetic material PPPIRIB / C to T will be measured in a saliva sample. Results will be reported as% difference from the general population.

  70. PPPIRIB / C to T at Week 4

    Time frame: week 4

    Evaluation of genetic material PPPIRIB / C to T will be measured in a saliva sample. Results will be reported as% difference from the general population.

  71. PPPIRIB / C to T at Week 8

    Time frame: week 8

    Evaluation of genetic material PPPIRIB / C to T will be measured in a saliva sample. Results will be reported as% difference from the general population.

  72. PPPIRIB / C to T at Week 12

    Time frame: week 12

    Evaluation of genetic material PPPIRIB / C to T will be measured in a saliva sample. Results will be reported as% difference from the general population.

  73. MAO-A /MAOA-H & MAOA-L at baseline

    Time frame: Baseline

    Evaluation of genetic material MAO-A /MAOA-H & MAOA-L will be measured in a saliva sample. Results will be reported as% difference from the general population.

  74. MAO-A /MAOA-H & MAOA-L at Week 4

    Time frame: Week 4

    Evaluation of genetic material MAO-A /MAOA-H & MAOA-L will be measured in a saliva sample. Results will be reported as% difference from the general population.

  75. MAO-A /MAOA-H & MAOA-L at Week 8

    Time frame: Week 8

    Evaluation of genetic material MAO-A /MAOA-H & MAOA-Lwill be measured in a saliva sample. Results will be reported as% difference from the general population.

  76. MAO-A /MAOA-H & MAOA-L at Week 12

    Time frame: Week 12

    Evaluation of genetic material MAO-A /MAOA-H & MAOA-L will be measured in a saliva sample. Results will be reported as% difference from the general population.

  77. 5-HTR2A / AI438G at baseline

    Time frame: Baseline

    Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as % difference from the general population.

  78. 5-HTR2A / AI438G at Week 4

    Time frame: Week 4

    Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  79. 5-HTR2A / AI438G at Week 8

    Time frame: Week 8

    Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  80. 5-HTR2A / AI438G at Week 12

    Time frame: Week 12

    Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  81. 5-HT1A / C1019G at baseline

    Time frame: Baseline

    Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  82. 5-HT1A / C1019G at Week 4

    Time frame: Week 4

    Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  83. 5-HT1A / C1019G at Week 8

    Time frame: Week 8

    Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  84. 5-HT1A / C1019G at Week 12

    Time frame: Week 12

    Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.

  85. 5-HTR2B / HTR2B Q20 at baseline

    Time frame: Baseline

    Evaluation of genetic material 5-HTR2B / HTR2B Q20 will be measured in a saliva sample. Results will be reported as% difference from the general population.

  86. 5-HTR2B / HTR2B Q20 at Week 4

    Time frame: Week 4

    Evaluation of genetic material 5-HTR2B / HTR2B Q20 will be measured in a saliva sample. Results will be reported as% difference from the general population.

  87. 5-HTR2B / HTR2B Q20 at Week 8

    Time frame: Week 8

    Evaluation of genetic material 5-HTR2B / HTR2B Q20 will be measured in a saliva sample. Results will be reported as% difference from the general population.

  88. 5-HTR2B / HTR2B Q20 at Week 12

    Time frame: Week 12

    Evaluation of genetic material 5-HTR2B / HTR2B Q20 will be measured in a saliva sample. Results will be reported as% difference from the general population.

  89. TPH / A218C & A779C at baseline

    Time frame: Baseline

    Evaluation of genetic material TPH / A218C & A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.

  90. TPH / A218C & A779C at Week 4

    Time frame: Week 4

    Evaluation of genetic material TPH / A218C & A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.

  91. TPH / A218C & A779C at Week 8

    Time frame: Week 8

    Evaluation of genetic material TPH / A218C & A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.

  92. TPH / A218C & A779C at Week 12

    Time frame: Week 12

    Evaluation of genetic material TPH / A218C & A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.

Sponsors and collaborators

Lead sponsor

Centre for Neuro Skills

Industry

Collaborators

  • University of Pittsburgh

Registry information

Official study title

Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury

Acronym: AER-TBI1

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Mar 28, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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