Clinical trial NCT05786729: Aerobic Exercise After Traumatic Brain Injury
Official title: Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Traumatic Brain Injury
Lead sponsor: Centre for Neuro Skills
Sponsor class: INDUSTRY
Collaborators: name: University of Pittsburgh
First posted: 2023-03-28
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention will consist of aerobic exercise sessions at predetermined heart rate range.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline
timeFrame: Baseline
measure: Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 4
timeFrame: Week 4
measure: Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 8
timeFrame: Week 8
measure: Aerobic Exercise Induced Changes in Cardio Pulmonary (CPET) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Aerobic Exercise Induced Changes in Cognitive Function at baseline
timeFrame: Baseline
measure: Aerobic Exercise Induced Changes in Cognitive Function at Week 4
timeFrame: Week 4
measure: Aerobic Exercise Induced Changes in Cognitive Function at Week 8
timeFrame: Week 8
measure: Aerobic Exercise Induced Changes in Cognitive Function at Week 12
timeFrame: Week 12
measure: Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at baseline
timeFrame: Baseline
measure: Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 4
timeFrame: Week 4
measure: Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 8
timeFrame: Week 8
measure: Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 12
timeFrame: Week 12
measure: Quality of Life Measured by the NeuroQOL at baseline
timeFrame: Baseline
measure: Quality of Life Measured by the NeuroQOL at Week 4
timeFrame: Week 4
measure: Quality of Life Measured by the NeuroQOL at Week 8
timeFrame: Week 8
measure: Quality of Life Measured by the NeuroQOL at Week 12
timeFrame: Week 12
measure: Depression measured by the Beck Depression Inventory-II at baseline
timeFrame: Baseline
measure: Depression measured by the Beck Depression Inventory-II at Week 4
timeFrame: Week 4
measure: Depression measured by the Beck Depression Inventory-II at Week 8
timeFrame: Week 8
measure: Depression measured by the Beck Depression Inventory-II at Week 12
timeFrame: Week 12
measure: Visual Search/ Processing Speed measured by Trail Making Test (TMT) at baseline
timeFrame: Baseline
measure: Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 4
timeFrame: Week 4
measure: Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 8
timeFrame: Week 8
measure: Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 12
timeFrame: Week 12
measure: Sleepiness will be measured by the Epworth Sleepiness Scale at baseline
timeFrame: Baseline
measure: Sleepiness will be measured by the Epworth Sleepiness Scale at Week 4
timeFrame: Week 4
measure: Sleepiness will be measured by the Epworth Sleepiness Scale at Week 8
timeFrame: Week 8
measure: Sleepiness will be measured by the Epworth Sleepiness Scale at Week 12
timeFrame: Week 12
measure: Vestibular function will be measured by the Berg Balance Test at baseline
timeFrame: Baseline
measure: Vestibular function will be measured by the Berg Balance Test at Week 4
timeFrame: Week 4
measure: Vestibular function will be measured by the Berg Balance Test at Week 8
timeFrame: Week 8
measure: Vestibular function will be measured by the Berg Balance Test at Week 12
timeFrame: Week 12
measure: Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at baseline
timeFrame: Baseline
measure: Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 4
timeFrame: Week 4
measure: Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 8
timeFrame: Week 8
measure: Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 12
timeFrame: Week 12
measure: Evaluation of Inflammatory Biomarkers at Baseline
timeFrame: Baseline
measure: Evaluation of Inflammatory Biomarkers at Week 4
timeFrame: Week 4
measure: Evaluation of Inflammatory Biomarkers at Week 8
timeFrame: Week 8
measure: Evaluation of Inflammatory Biomarkers at Week 12
timeFrame: Week 12
measure: Evaluation of Neuroplasticity, Stress Biomarkers at Baseline
timeFrame: Baseline
measure: Evaluation of Neuroplasticity, Stress Biomarkers at Week 4
timeFrame: Week 4
measure: Evaluation of Neuroplasticity, Stress Biomarkers at Week 8
timeFrame: Week 8
measure: Evaluation of Neuroplasticity, Stress Biomarkers at Week 12
timeFrame: Week 12
measure: Evaluation of Neurodegeneration Biomarkers at Baseline
timeFrame: Baseline
measure: Evaluation of Neurodegeneration Biomarkers at Week 4
timeFrame: Week 4
measure: Evaluation of Neurodegeneration Biomarkers at Week 8
timeFrame: Week 8
measure: Evaluation of Neurodegeneration Biomarkers at Week 12
timeFrame: Week 12
measure: BDNF / Val66Met at baseline
timeFrame: Baseline
measure: BDNF / Val66Met at Week 4
timeFrame: Week 4
measure: BDNF / Val66Met at Week 8
timeFrame: Week 8
measure: BDNF / Val66Met at Week 12
timeFrame: Week 12
measure: IL-1β / rs16944 at baseline
timeFrame: Baseline
measure: IL-1β / rs16944 at Week 4
timeFrame: Week 4
measure: IL-1β / rs16944 at Week 8
timeFrame: Week 8
measure: IL-1β / rs16944 at Week 12
timeFrame: Week 12
measure: TrkB at baseline
timeFrame: Baseline
measure: TrkB at Week 4
timeFrame: Week 4
measure: TrkB at Week 8
timeFrame: Week 8
measure: TrkB at Week 12
timeFrame: Week 12
measure: COMT / VAll58Met at baseline
timeFrame: Baseline
measure: COMT / VAll58Met at Week 4
timeFrame: Week 4
measure: COMT / VAll58Met at Week 8
timeFrame: Week 8
measure: COMT / VAll58Met at Week 12
timeFrame: Week 12
measure: DRD2 / A to T & A to G at baseline
timeFrame: Baseline
measure: DRD2 / A to T & A to G at Week 4
timeFrame: Week 4
measure: DRD2 / A to T & A to G at Week 8
timeFrame: Week 8
measure: DRD2 / A to T & A to G at Week 12
timeFrame: Week 12
measure: ANKKI / TAQIA at baseline
timeFrame: Baseline
measure: ANKKI / TAQIA at Week 4
timeFrame: Week 4
measure: ANKKI / TAQIA at Week 8
timeFrame: Week 8
measure: ANKKI / TAQIA at Week 12
timeFrame: Week 12
measure: PPPIRIB / C to T at baseline
timeFrame: Baseline
measure: PPPIRIB / C to T at Week 4
timeFrame: week 4
measure: PPPIRIB / C to T at Week 8
timeFrame: week 8
measure: PPPIRIB / C to T at Week 12
timeFrame: week 12
measure: MAO-A /MAOA-H & MAOA-L at baseline
timeFrame: Baseline
measure: MAO-A /MAOA-H & MAOA-L at Week 4
timeFrame: Week 4
measure: MAO-A /MAOA-H & MAOA-L at Week 8
timeFrame: Week 8
measure: MAO-A /MAOA-H & MAOA-L at Week 12
timeFrame: Week 12
measure: 5-HTR2A / AI438G at baseline
timeFrame: Baseline
measure: 5-HTR2A / AI438G at Week 4
timeFrame: Week 4
measure: 5-HTR2A / AI438G at Week 8
timeFrame: Week 8
measure: 5-HTR2A / AI438G at Week 12
timeFrame: Week 12
measure: 5-HT1A / C1019G at baseline
timeFrame: Baseline
measure: 5-HT1A / C1019G at Week 4
timeFrame: Week 4
measure: 5-HT1A / C1019G at Week 8
timeFrame: Week 8
measure: 5-HT1A / C1019G at Week 12
timeFrame: Week 12
measure: 5-HTR2B / HTR2B Q20 at baseline
timeFrame: Baseline
measure: 5-HTR2B / HTR2B Q20 at Week 4
timeFrame: Week 4
measure: 5-HTR2B / HTR2B Q20 at Week 8
timeFrame: Week 8
measure: 5-HTR2B / HTR2B Q20 at Week 12
timeFrame: Week 12
measure: TPH / A218C & A779C at baseline
timeFrame: Baseline
measure: TPH / A218C & A779C at Week 4
timeFrame: Week 4
measure: TPH / A218C & A779C at Week 8
timeFrame: Week 8
measure: TPH / A218C & A779C at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Centre for Neuro Skills
state: California
Study officials:
affiliation: Centre for Neuro Skills
name: Grace S Griesbach, PhD
role: PRINCIPAL_INVESTIGATOR
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