AzTrials
AzTrials

Traumatic Brain InjuryPhase 1/2AER-TBI1NCT05786729

Aerobic Exercise After Traumatic Brain Injury

A Phase 1/2 study testing Aerobic Exercise (AER) and Rehabilitation in people with Traumatic Brain Injury, run by Centre for Neuro Skills at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Aerobic Exercise (AER) and Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteUnited States
Study dates
18 Jan 2022to 18 Jan 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • Inability to cooperate
  • Orthopedic impairment that compromises exercise performance
  • Any cardiovascular or respiratory condition that jeopardizes patient health during exercise.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Centre for Neuro Skills

    Bakersfield, California, 93313

Other trials in United States

About this study

Official title: Effects of Aerobic Exercise and Rehabilitation 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.

Read the detailed description

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.

Being tested
Aerobic Exercise (AER), Rehabilitation
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic Exercise (AER)Other

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

  • RehabilitationOther

    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.

Study groups in NCT05786729
Study groupRoleWhat they receive
Intervention Aerobic Exercise (AER)ExperimentalConsented participants will be randomly assigned to aerobic exercise regimen (AER) + Standard Rehabilitation(R+AER) or Standard Rehabilitation only (R) group. In order to determine the necessary time window for AER exercise treatment, TBI subjects will partake in supervised AER sessions for a period of 12 weeks. After a baseline evaluations follow-ups will take place at take place at weeks 4, 8 and 12. Thus each participants will be evaluated 4 times.
Receives: Other: Aerobic Exercise (AER)
Rehabilitation (R)Active comparatorParticipants with traumatic brain injury that are enrolled in a comprehensive rehabilitation program. These participants will receive standard rehabilitation. Given that the duration of the rehabilitative program is variable the duration of participation will be no less than 4 weeks and will not exceed 12 weeks. Activity levels will be monitored.
Receives: Other: Rehabilitation
Control (C)No interventionHealthy volunteers' responsiveness to exercise will be compared to TBI responsiveness.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline

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

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

    Measured: Week 4

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

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

    Measured: Week 8

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

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

    Measured: Week 12

Secondary outcomes (92)

  1. Aerobic Exercise Induced Changes in Cognitive Function at 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.

    Measured: Baseline

  2. Aerobic Exercise Induced Changes in Cognitive Function at 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.

    Measured: Week 4

  3. Aerobic Exercise Induced Changes in Cognitive Function at 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.

    Measured: Week 8

  4. Aerobic Exercise Induced Changes in Cognitive Function at 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.

    Measured: Week 12

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

    Measured: Baseline

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

    Measured: Week 4

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

    Measured: Week 8

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

    Measured: Week 12

  9. Quality of Life Measured by the NeuroQOL at 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

    Measured: Baseline

  10. Quality of Life Measured by the NeuroQOL at 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

    Measured: Week 4

  11. Quality of Life Measured by the NeuroQOL at 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

    Measured: Week 8

  12. Quality of Life Measured by the NeuroQOL at 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

    Measured: Week 12

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

    Measured: Baseline

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

    Measured: Week 4

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

    Measured: Week 8

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

    Measured: Week 12

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

    Measured: Baseline

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

    Measured: Week 4

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

    Measured: Week 8

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

    Measured: Week 12

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

    Measured: Baseline

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

    Measured: Week 4

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

    Measured: Week 8

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

    Measured: Week 12

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

    Measured: Baseline

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

    Measured: Week 4

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

    Measured: Week 8

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

    Measured: Week 12

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

    Measured: Baseline

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

    Measured: Week 4

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

    Measured: Week 8

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

    Measured: Week 12

  33. Evaluation of Inflammatory Biomarkers at 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.

    Measured: Baseline

  34. Evaluation of Inflammatory Biomarkers at 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.

    Measured: Week 4

  35. Evaluation of Inflammatory Biomarkers at 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.

    Measured: Week 8

  36. Evaluation of Inflammatory Biomarkers at 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.

    Measured: Week 12

  37. Evaluation of Neuroplasticity, Stress Biomarkers at 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.

    Measured: Baseline

  38. Evaluation of Neuroplasticity, Stress Biomarkers at 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.

    Measured: Week 4

  39. Evaluation of Neuroplasticity, Stress Biomarkers at 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.

    Measured: Week 8

  40. Evaluation of Neuroplasticity, Stress Biomarkers at 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.

    Measured: Week 12

  41. Evaluation of Neurodegeneration Biomarkers at 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.

    Measured: Baseline

  42. Evaluation of Neurodegeneration Biomarkers at 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.

    Measured: Week 4

  43. Evaluation of Neurodegeneration Biomarkers at 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.

    Measured: Week 8

  44. Evaluation of Neurodegeneration Biomarkers at 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.

    Measured: Week 12

  45. BDNF / Val66Met at baseline

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

    Measured: Baseline

  46. BDNF / Val66Met at 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.

    Measured: Week 4

  47. BDNF / Val66Met at 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.

    Measured: Week 8

  48. BDNF / Val66Met at 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.

    Measured: Week 12

  49. IL-1β / rs16944 at 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.

    Measured: Baseline

  50. IL-1β / rs16944 at 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.

    Measured: Week 4

  51. IL-1β / rs16944 at 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.

    Measured: Week 8

  52. IL-1β / rs16944 at 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.

    Measured: Week 12

  53. TrkB at baseline

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

    Measured: Baseline

  54. TrkB at Week 4

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

    Measured: Week 4

  55. TrkB at Week 8

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

    Measured: Week 8

  56. TrkB at Week 12

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

    Measured: Week 12

  57. COMT / VAll58Met at baseline

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

    Measured: Baseline

  58. COMT / VAll58Met at 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.

    Measured: Week 4

  59. COMT / VAll58Met at 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.

    Measured: Week 8

  60. COMT / VAll58Met at 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.

    Measured: Week 12

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

    Measured: Baseline

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

    Measured: Week 4

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

    Measured: Week 8

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

    Measured: Week 12

  65. ANKKI / TAQIA at baseline

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

    Measured: Baseline

  66. ANKKI / TAQIA at 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.

    Measured: Week 4

  67. ANKKI / TAQIA at 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.

    Measured: Week 8

  68. ANKKI / TAQIA at 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.

    Measured: Week 12

  69. PPPIRIB / C to T at 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.

    Measured: Baseline

  70. PPPIRIB / C to T at 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.

    Measured: week 4

  71. PPPIRIB / C to T at 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.

    Measured: week 8

  72. PPPIRIB / C to T at 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.

    Measured: week 12

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

    Measured: Baseline

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

    Measured: Week 4

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

    Measured: Week 8

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

    Measured: Week 12

  77. 5-HTR2A / AI438G at 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.

    Measured: Baseline

  78. 5-HTR2A / AI438G at 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.

    Measured: Week 4

  79. 5-HTR2A / AI438G at 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.

    Measured: Week 8

  80. 5-HTR2A / AI438G at 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.

    Measured: Week 12

  81. 5-HT1A / C1019G at 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.

    Measured: Baseline

  82. 5-HT1A / C1019G at 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.

    Measured: Week 4

  83. 5-HT1A / C1019G at 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.

    Measured: Week 8

  84. 5-HT1A / C1019G at 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.

    Measured: Week 12

  85. 5-HTR2B / HTR2B Q20 at 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.

    Measured: Baseline

  86. 5-HTR2B / HTR2B Q20 at 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.

    Measured: Week 4

  87. 5-HTR2B / HTR2B Q20 at 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.

    Measured: Week 8

  88. 5-HTR2B / HTR2B Q20 at 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.

    Measured: Week 12

  89. TPH / A218C & A779C at 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.

    Measured: Baseline

  90. TPH / A218C & A779C at 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.

    Measured: Week 4

  91. TPH / A218C & A779C at 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.

    Measured: Week 8

  92. TPH / A218C & A779C at 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2023
  2. Study start18 Jan 2022
  3. Primary completion18 Jan 2027 (estimated)
  4. Study completion18 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention will consist of aerobic exercise sessions at predetermined heart rate range.
Masking
None (open label)
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05786729
Sponsor's protocol ID
Pro00016168
Acronym
AER-TBI1
Status last verified
Mar 2023
First submitted
16 Mar 2022
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ashman TA, Gordon WA, Cantor JB, Hibbard MR. Neurobehavioral consequences of traumatic brain injury. Mt Sinai J Med. 2006 Nov;73(7):999-1005.

    PubMed 17195886

  • Kleim JA, Jones TA, Schallert T. Motor enrichment and the induction of plasticity before or after brain injury. Neurochem Res. 2003 Nov;28(11):1757-69. doi: 10.1023/a:1026025408742.

    PubMed 14584829

  • Griesbach GS, Hovda DA, Molteni R, Wu A, Gomez-Pinilla F. Voluntary exercise following traumatic brain injury: brain-derived neurotrophic factor upregulation and recovery of function. Neuroscience. 2004;125(1):129-39. doi: 10.1016/j.neuroscience.2004.01.030.

    PubMed 15051152

  • Griesbach GS, Hovda DA, Gomez-Pinilla F. Exercise-induced improvement in cognitive performance after traumatic brain injury in rats is dependent on BDNF activation. Brain Res. 2009 Sep 8;1288:105-15. doi: 10.1016/j.brainres.2009.06.045. Epub 2009 Jun 23.

    PubMed 19555673

  • Seifert T, Brassard P, Wissenberg M, Rasmussen P, Nordby P, Stallknecht B, Adser H, Jakobsen AH, Pilegaard H, Nielsen HB, Secher NH. Endurance training enhances BDNF release from the human brain. Am J Physiol Regul Integr Comp Physiol. 2010 Feb;298(2):R372-7. doi: 10.1152/ajpregu.00525.2009. Epub 2009 Nov 18.

    PubMed 19923361

  • Johnson VE, Stewart W, Smith DH. Axonal pathology in traumatic brain injury. Exp Neurol. 2013 Aug;246:35-43. doi: 10.1016/j.expneurol.2012.01.013. Epub 2012 Jan 20.

    PubMed 22285252

  • Povlishock JT, Pettus EH. Traumatically induced axonal damage: evidence for enduring changes in axolemmal permeability with associated cytoskeletal change. Acta Neurochir Suppl. 1996;66:81-6. doi: 10.1007/978-3-7091-9465-2_15.

    PubMed 8780803

  • Schuit AJ, Feskens EJ, Launer LJ, Kromhout D. Physical activity and cognitive decline, the role of the apolipoprotein e4 allele. Med Sci Sports Exerc. 2001 May;33(5):772-7. doi: 10.1097/00005768-200105000-00015.

    PubMed 11323547

  • Adlard PA, Perreau VM, Pop V, Cotman CW. Voluntary exercise decreases amyloid load in a transgenic model of Alzheimer's disease. J Neurosci. 2005 Apr 27;25(17):4217-21. doi: 10.1523/JNEUROSCI.0496-05.2005.

    PubMed 15858047

  • Piao CS, Stoica BA, Wu J, Sabirzhanov B, Zhao Z, Cabatbat R, Loane DJ, Faden AI. Late exercise reduces neuroinflammation and cognitive dysfunction after traumatic brain injury. Neurobiol Dis. 2013 Jun;54:252-63. doi: 10.1016/j.nbd.2012.12.017. Epub 2013 Jan 8.

    PubMed 23313314

  • Norden DM, Muccigrosso MM, Godbout JP. Microglial priming and enhanced reactivity to secondary insult in aging, and traumatic CNS injury, and neurodegenerative disease. Neuropharmacology. 2015 Sep;96(Pt A):29-41. doi: 10.1016/j.neuropharm.2014.10.028. Epub 2014 Nov 13.

    PubMed 25445485

  • Gurley JM, Hujsak BD, Kelly JL. Vestibular rehabilitation following mild traumatic brain injury. NeuroRehabilitation. 2013;32(3):519-28. doi: 10.3233/NRE-130874.

    PubMed 23648606

  • Rinne MB, Pasanen ME, Vartiainen MV, Lehto TM, Sarajuuri JM, Alaranta HT. Motor performance in physically well-recovered men with traumatic brain injury. J Rehabil Med. 2006 Jul;38(4):224-9. doi: 10.1080/16501970600582989.

    PubMed 16801204

  • Bland DC, Zampieri C, Damiano DL. Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. Brain Inj. 2011;25(7-8):664-79. doi: 10.3109/02699052.2011.576306. Epub 2011 May 11.

    PubMed 21561297

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Aerobic Exercise (AER) and Rehabilitation in people with Traumatic Brain Injury, run by Centre for Neuro Skills at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05786729, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

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