Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury

Centre for Neuro Skills1 site in 1 country190 target enrollmentJanuary 18, 2022

ConditionsTraumatic Brain Injury

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Traumatic Brain Injury
Sponsor: Centre for Neuro Skills
Enrollment: 190
Locations: 1
Primary Endpoint: Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline
Status: Enrolling by Invitation
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 18, 2022

End Date

January 18, 2028

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre for Neuro Skills

Responsible Party

Principal Investigator

Grace S. Griesbach

National Director of Clinical Research

Centre for Neuro Skills

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.

Outcomes

Primary Outcomes

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

Time Frame: Baseline

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

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

Time Frame: Week 4

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

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

Time Frame: Week 12

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

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

Time Frame: Week 8

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

Secondary Outcomes

Aerobic Exercise Induced Changes in Cognitive Function at Week 12(Week 12)
Aerobic Exercise Induced Changes in Cognitive Function at Week 4(Week 4)
Aerobic Exercise Induced Changes in Cognitive Function at Week 8(Week 8)
Aerobic Exercise Induced Changes in Cognitive Function at baseline(Baseline)
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at baseline(Baseline)
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 4(Week 4)
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 12(Week 12)
Quality of Life Measured by the NeuroQOL at baseline(Baseline)
Quality of Life Measured by the NeuroQOL at Week 4(Week 4)
Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 8(Week 8)
Quality of Life Measured by the NeuroQOL at Week 8(Week 8)
Quality of Life Measured by the NeuroQOL at Week 12(Week 12)
Depression measured by the Beck Depression Inventory-II at baseline(Baseline)
Depression measured by the Beck Depression Inventory-II at Week 4(Week 4)
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at baseline(Baseline)
Sleepiness will be measured by the Epworth Sleepiness Scale at Week 4(Week 4)
Vestibular function will be measured by the Berg Balance Test at Week 4(Week 4)
Depression measured by the Beck Depression Inventory-II at Week 8(Week 8)
Depression measured by the Beck Depression Inventory-II at Week 12(Week 12)
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 4(Week 4)
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 12(Week 12)
Sleepiness will be measured by the Epworth Sleepiness Scale at baseline(Baseline)
Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 8(Week 8)
Sleepiness will be measured by the Epworth Sleepiness Scale at Week 8(Week 8)
Sleepiness will be measured by the Epworth Sleepiness Scale at Week 12(Week 12)
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at baseline(Baseline)
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 4(Week 4)
Vestibular function will be measured by the Berg Balance Test at baseline(Baseline)
Vestibular function will be measured by the Berg Balance Test at Week 12(Week 12)
Vestibular function will be measured by the Berg Balance Test at Week 8(Week 8)
Evaluation of Inflammatory Biomarkers at Week 4(Week 4)
Evaluation of Inflammatory Biomarkers at Week 8(Week 8)
Evaluation of Inflammatory Biomarkers at Week 12(Week 12)
Evaluation of Neuroplasticity, Stress Biomarkers at Baseline(Baseline)
Evaluation of Neurodegeneration Biomarkers at Week 4(Week 4)
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 8(Week 8)
Evaluation of Neuroplasticity, Stress Biomarkers at Week 8(Week 8)
BDNF / Val66Met at Week 8(Week 8)
Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 12(Week 12)
Evaluation of Neuroplasticity, Stress Biomarkers at Week 4(Week 4)
Evaluation of Neuroplasticity, Stress Biomarkers at Week 12(Week 12)
Evaluation of Neurodegeneration Biomarkers at Week 8(Week 8)
Evaluation of Neurodegeneration Biomarkers at Week 12(Week 12)
Evaluation of Inflammatory Biomarkers at Baseline(Baseline)
Evaluation of Neurodegeneration Biomarkers at Baseline(Baseline)
BDNF / Val66Met at baseline(Baseline)
BDNF / Val66Met at Week 4(Week 4)
BDNF / Val66Met at Week 12(Week 12)
IL-1β / rs16944 at baseline(Baseline)
IL-1β / rs16944 at Week 4(Week 4)
IL-1β / rs16944 at Week 8(Week 8)
IL-1β / rs16944 at Week 12(Week 12)
TrkB at baseline(Baseline)
COMT / VAll58Met at Week 4(Week 4)
COMT / VAll58Met at Week 12(Week 12)
DRD2 / A to T & A to G at baseline(Baseline)
ANKKI / TAQIA at baseline(Baseline)
ANKKI / TAQIA at Week 12(Week 12)
PPPIRIB / C to T at baseline(Baseline)
TrkB at Week 4(Week 4)
TrkB at Week 8(Week 8)
TrkB at Week 12(Week 12)
COMT / VAll58Met at baseline(Baseline)
COMT / VAll58Met at Week 8(Week 8)
DRD2 / A to T & A to G at Week 8(Week 8)
DRD2 / A to T & A to G at Week 4(Week 4)
DRD2 / A to T & A to G at Week 12(Week 12)
ANKKI / TAQIA at Week 4(Week 4)
PPPIRIB / C to T at Week 4(week 4)
5-HTR2A / AI438G at Week 4(Week 4)
5-HT1A / C1019G at baseline(Baseline)
5-HT1A / C1019G at Week 12(Week 12)
5-HTR2B / HTR2B Q20 at Week 8(Week 8)
ANKKI / TAQIA at Week 8(Week 8)
MAO-A /MAOA-H & MAOA-L at baseline(Baseline)
MAO-A /MAOA-H & MAOA-L at Week 4(Week 4)
PPPIRIB / C to T at Week 8(week 8)
MAO-A /MAOA-H & MAOA-L at Week 8(Week 8)
MAO-A /MAOA-H & MAOA-L at Week 12(Week 12)
5-HTR2A / AI438G at baseline(Baseline)
5-HTR2A / AI438G at Week 8(Week 8)
5-HT1A / C1019G at Week 4(Week 4)
PPPIRIB / C to T at Week 12(week 12)
5-HTR2A / AI438G at Week 12(Week 12)
5-HT1A / C1019G at Week 8(Week 8)
5-HTR2B / HTR2B Q20 at baseline(Baseline)
TPH / A218C & A779C at Week 4(Week 4)
TPH / A218C & A779C at Week 12(Week 12)
5-HTR2B / HTR2B Q20 at Week 4(Week 4)
5-HTR2B / HTR2B Q20 at Week 12(Week 12)
TPH / A218C & A779C at baseline(Baseline)
TPH / A218C & A779C at Week 8(Week 8)