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Exercise and Rehabilitation After Traumatic Brain Injury

Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03407924
Enrollment
120
Registered
2018-01-23
Start date
2016-06-30
Completion date
2022-03-31
Last updated
2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Brief summary

The purpose of this study is to examine the effects of exercise on recovery after traumatic brain injury. Investigators will determine if exercise enhances rehabilitation by increasing substances (proteins) that can facilitate recovery.

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, memory and inflammation influence the responsiveness to exercise and rehabilitation. Particular genetic polymorphisms involved in neuroplasticity and inflammatory responses will be evaluated. Recovery will be determined by assessing cognitive function, life quality and balance.

Interventions

Aerobic exercise will be performed with a treadmill or stationary tandem bike 3 times per week. Each exercise session will take about 30 minutes plus 5 to 10 min of warm-up and cool-down. Participants will wear a safety harness.

OTHERRehabilitation

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.

Sponsors

Centre for Neuro Skills
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Intervention will consist of aerobic exercise sessions at predetermined heart rate range.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Clinical diagnosis of TBI (for R+AER and R groups). * Fluency in English or Spanish. * Able to walk with or without a device.

Exclusion criteria

* Orthopedic or cardiac conditions that prevent from exercising. * Current diagnosis of neurological and/or psychiatric diseases. Unable to be in the Los Angeles CA metropolitan area for the duration of the study

Design outcomes

Primary

MeasureTime frameDescription
Aerobic Exercise Induced Changes in Cognitive Function5 yearsAttention, 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 Inflammatory responses to exercise4 to 30 weeks depending on the duration of rehabilitation coverage.Selected analytes will be evaluated from serum.
Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness4 to 30 weeks depending on the duration of rehabilitation coverage.Ventilatory Threshold (aerobic capacity)
Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise4 to 30 weeks depending on the duration of rehabilitation coverage.Selected analytes will be evaluated from serum.

Secondary

MeasureTime frameDescription
Aerobic Exercise Induced Changes in Depression Symptoms4 to 30 weeks depending on the duration of rehabilitation coverage.Beck Depression Inventory
Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.4 to 30 weeks depending on the duration of rehabilitation coverage.Genetic material will be obtained.

Other

MeasureTime frameDescription
Verbal Memory4 to 30 weeks depending on the duration of rehabilitation coverage.California Verbal Learning Test (CVLT II).
Quality of Life4 to 30 weeks depending on the duration of rehabilitation coverage.Quality of Life in Neurological Disorders (Neuro-QoL)
Visual Search/Processing Speed4 to 30 weeks depending on the duration of rehabilitation coverage.Trail Making

Countries

United States

Contacts

Primary ContactGrace S Griesbach, PhD
researchcentre@neuroskills.com(818)783-3800
Backup ContactLisa Kreber, PhD
researchcentre@neuroskills.com(661)873-6513

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026