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Aerobic Exercise After Traumatic Brain Injury (AER-TBI1)

Primary Purpose

Traumatic Brain Injury

Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise (AER)
Rehabilitation
Sponsored by
Centre for Neuro Skills
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre for Neuro Skills

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Intervention Aerobic Exercise (AER)

Rehabilitation (R)

Control (C)

Arm Description

Consented 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.

Participants 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.

Healthy volunteers' responsiveness to exercise will be compared to TBI responsiveness.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 16, 2022
Last Updated
March 14, 2023
Sponsor
Centre for Neuro Skills
Collaborators
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT05786729
Brief Title
Aerobic Exercise After Traumatic Brain Injury
Acronym
AER-TBI1
Official Title
Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
January 18, 2027 (Anticipated)
Study Completion Date
January 18, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Neuro Skills
Collaborators
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Intervention will consist of aerobic exercise sessions at predetermined heart rate range.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Aerobic Exercise (AER)
Arm Type
Experimental
Arm Description
Consented 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.
Arm Title
Rehabilitation (R)
Arm Type
Active Comparator
Arm Description
Participants 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.
Arm Title
Control (C)
Arm Type
No Intervention
Arm Description
Healthy volunteers' responsiveness to exercise will be compared to TBI responsiveness.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise (AER)
Intervention Description
Aerobic exercise will be performed by utilizing aerobic exercise equipment 3 times per week.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline
Description
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Time Frame
Baseline
Title
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 4
Description
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Time Frame
Week 4
Title
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 8
Description
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Time Frame
Week 8
Title
Aerobic Exercise Induced Changes in Cardio Pulmonary (CPET) at Week 12
Description
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Aerobic Exercise Induced Changes in Cognitive Function at baseline
Description
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.
Time Frame
Baseline
Title
Aerobic Exercise Induced Changes in Cognitive Function at Week 4
Description
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.
Time Frame
Week 4
Title
Aerobic Exercise Induced Changes in Cognitive Function at Week 8
Description
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.
Time Frame
Week 8
Title
Aerobic Exercise Induced Changes in Cognitive Function at Week 12
Description
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.
Time Frame
Week 12
Title
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at baseline
Description
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.
Time Frame
Baseline
Title
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 4
Description
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.
Time Frame
Week 4
Title
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 8
Description
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.
Time Frame
Week 8
Title
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 12
Description
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.
Time Frame
Week 12
Title
Quality of Life Measured by the NeuroQOL at baseline
Description
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
Time Frame
Baseline
Title
Quality of Life Measured by the NeuroQOL at Week 4
Description
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
Time Frame
Week 4
Title
Quality of Life Measured by the NeuroQOL at Week 8
Description
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
Time Frame
Week 8
Title
Quality of Life Measured by the NeuroQOL at Week 12
Description
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
Time Frame
Week 12
Title
Depression measured by the Beck Depression Inventory-II at baseline
Description
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.
Time Frame
Baseline
Title
Depression measured by the Beck Depression Inventory-II at Week 4
Description
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.
Time Frame
Week 4
Title
Depression measured by the Beck Depression Inventory-II at Week 8
Description
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.
Time Frame
Week 8
Title
Depression measured by the Beck Depression Inventory-II at Week 12
Description
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.
Time Frame
Week 12
Title
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at baseline
Description
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.
Time Frame
Baseline
Title
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 4
Description
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.
Time Frame
Week 4
Title
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 8
Description
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.
Time Frame
Week 8
Title
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 12
Description
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.
Time Frame
Week 12
Title
Sleepiness will be measured by the Epworth Sleepiness Scale at baseline
Description
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.
Time Frame
Baseline
Title
Sleepiness will be measured by the Epworth Sleepiness Scale at Week 4
Description
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.
Time Frame
Week 4
Title
Sleepiness will be measured by the Epworth Sleepiness Scale at Week 8
Description
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.
Time Frame
Week 8
Title
Sleepiness will be measured by the Epworth Sleepiness Scale at Week 12
Description
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.
Time Frame
Week 12
Title
Vestibular function will be measured by the Berg Balance Test at baseline
Description
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.
Time Frame
Baseline
Title
Vestibular function will be measured by the Berg Balance Test at Week 4
Description
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.
Time Frame
Week 4
Title
Vestibular function will be measured by the Berg Balance Test at Week 8
Description
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.
Time Frame
Week 8
Title
Vestibular function will be measured by the Berg Balance Test at Week 12
Description
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.
Time Frame
Week 12
Title
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at baseline
Description
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.
Time Frame
Baseline
Title
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 4
Description
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.
Time Frame
Week 4
Title
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 8
Description
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.
Time Frame
Week 8
Title
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 12
Description
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.
Time Frame
Week 12
Title
Evaluation of Inflammatory Biomarkers at Baseline
Description
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.
Time Frame
Baseline
Title
Evaluation of Inflammatory Biomarkers at Week 4
Description
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.
Time Frame
Week 4
Title
Evaluation of Inflammatory Biomarkers at Week 8
Description
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.
Time Frame
Week 8
Title
Evaluation of Inflammatory Biomarkers at Week 12
Description
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.
Time Frame
Week 12
Title
Evaluation of Neuroplasticity, Stress Biomarkers at Baseline
Description
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.
Time Frame
Baseline
Title
Evaluation of Neuroplasticity, Stress Biomarkers at Week 4
Description
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.
Time Frame
Week 4
Title
Evaluation of Neuroplasticity, Stress Biomarkers at Week 8
Description
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.
Time Frame
Week 8
Title
Evaluation of Neuroplasticity, Stress Biomarkers at Week 12
Description
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.
Time Frame
Week 12
Title
Evaluation of Neurodegeneration Biomarkers at Baseline
Description
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.
Time Frame
Baseline
Title
Evaluation of Neurodegeneration Biomarkers at Week 4
Description
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.
Time Frame
Week 4
Title
Evaluation of Neurodegeneration Biomarkers at Week 8
Description
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.
Time Frame
Week 8
Title
Evaluation of Neurodegeneration Biomarkers at Week 12
Description
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.
Time Frame
Week 12
Title
BDNF / Val66Met at baseline
Description
Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Baseline
Title
BDNF / Val66Met at Week 4
Description
Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 4
Title
BDNF / Val66Met at Week 8
Description
Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 8
Title
BDNF / Val66Met at Week 12
Description
Evaluation of genetic material BDNF / Val66Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 12
Title
IL-1β / rs16944 at baseline
Description
Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Baseline
Title
IL-1β / rs16944 at Week 4
Description
Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 4
Title
IL-1β / rs16944 at Week 8
Description
Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 8
Title
IL-1β / rs16944 at Week 12
Description
Evaluation of genetic material IL-1β / rs16944 will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 12
Title
TrkB at baseline
Description
Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Baseline
Title
TrkB at Week 4
Description
Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 4
Title
TrkB at Week 8
Description
Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 8
Title
TrkB at Week 12
Description
Evaluation of genetic material TrkB will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 12
Title
COMT / VAll58Met at baseline
Description
Evaluation of genetic material COMT / VAll58Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Baseline
Title
COMT / VAll58Met at Week 4
Description
Evaluation of genetic material COMT / VAll58Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 4
Title
COMT / VAll58Met at Week 8
Description
Evaluation of genetic material COMT / VAll58Met will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 8
Title
COMT / VAll58Met at Week 12
Description
Evaluation of genetic material COMT / VAll58Met ewill be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 12
Title
DRD2 / A to T & A to G at baseline
Description
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.
Time Frame
Baseline
Title
DRD2 / A to T & A to G at Week 4
Description
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.
Time Frame
Week 4
Title
DRD2 / A to T & A to G at Week 8
Description
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.
Time Frame
Week 8
Title
DRD2 / A to T & A to G at Week 12
Description
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.
Time Frame
Week 12
Title
ANKKI / TAQIA at baseline
Description
Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Baseline
Title
ANKKI / TAQIA at Week 4
Description
Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 4
Title
ANKKI / TAQIA at Week 8
Description
Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 8
Title
ANKKI / TAQIA at Week 12
Description
Evaluation of genetic material ANKKI / TAQIA will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 12
Title
PPPIRIB / C to T at baseline
Description
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.
Time Frame
Baseline
Title
PPPIRIB / C to T at Week 4
Description
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.
Time Frame
week 4
Title
PPPIRIB / C to T at Week 8
Description
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.
Time Frame
week 8
Title
PPPIRIB / C to T at Week 12
Description
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.
Time Frame
week 12
Title
MAO-A /MAOA-H & MAOA-L at baseline
Description
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.
Time Frame
Baseline
Title
MAO-A /MAOA-H & MAOA-L at Week 4
Description
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.
Time Frame
Week 4
Title
MAO-A /MAOA-H & MAOA-L at Week 8
Description
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.
Time Frame
Week 8
Title
MAO-A /MAOA-H & MAOA-L at Week 12
Description
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.
Time Frame
Week 12
Title
5-HTR2A / AI438G at baseline
Description
Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as % difference from the general population.
Time Frame
Baseline
Title
5-HTR2A / AI438G at Week 4
Description
Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 4
Title
5-HTR2A / AI438G at Week 8
Description
Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 8
Title
5-HTR2A / AI438G at Week 12
Description
Evaluation of genetic material 5-HTR2A / AI438G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 12
Title
5-HT1A / C1019G at baseline
Description
Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Baseline
Title
5-HT1A / C1019G at Week 4
Description
Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 4
Title
5-HT1A / C1019G at Week 8
Description
Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 8
Title
5-HT1A / C1019G at Week 12
Description
Evaluation of genetic material 5-HT1A / C1019G will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 12
Title
5-HTR2B / HTR2B Q20 at baseline
Description
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.
Time Frame
Baseline
Title
5-HTR2B / HTR2B Q20 at Week 4
Description
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.
Time Frame
Week 4
Title
5-HTR2B / HTR2B Q20 at Week 8
Description
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.
Time Frame
Week 8
Title
5-HTR2B / HTR2B Q20 at Week 12
Description
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.
Time Frame
Week 12
Title
TPH / A218C & A779C at baseline
Description
Evaluation of genetic material TPH / A218C & A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Baseline
Title
TPH / A218C & A779C at Week 4
Description
Evaluation of genetic material TPH / A218C & A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 4
Title
TPH / A218C & A779C at Week 8
Description
Evaluation of genetic material TPH / A218C & A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 8
Title
TPH / A218C & A779C at Week 12
Description
Evaluation of genetic material TPH / A218C & A779C will be measured in a saliva sample. Results will be reported as% difference from the general population.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace S Griesbach, PhD
Organizational Affiliation
Centre for Neuro Skills
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Neuro Skills
City
Bakersfield
State/Province
California
ZIP/Postal Code
93313
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17195886
Citation
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Citation
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PubMed Identifier
15051152
Citation
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.
Results Reference
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PubMed Identifier
19555673
Citation
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.
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PubMed Identifier
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Aerobic Exercise After Traumatic Brain Injury

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