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Clinical Trials/NCT03407924
NCT03407924
Unknown
Phase 1

Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury

Centre for Neuro Skills1 site in 1 country120 target enrollmentJune 2016

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Centre for Neuro Skills
Enrollment
120
Locations
1
Primary Endpoint
Aerobic Exercise Induced Changes in Inflammatory responses to exercise
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
March 2022
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Grace S. Griesbach

National Director of Clinical Research

Centre for Neuro Skills

Eligibility Criteria

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

Outcomes

Primary Outcomes

Aerobic Exercise Induced Changes in Inflammatory responses to exercise

Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.

Selected analytes will be evaluated from serum.

Aerobic Exercise Induced Changes in Cognitive Function

Time Frame: 5 years

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 Cardio Pulmonary Fitness

Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.

Ventilatory Threshold (aerobic capacity)

Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise

Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.

Selected analytes will be evaluated from serum.

Secondary Outcomes

  • Aerobic Exercise Induced Changes in Depression Symptoms(4 to 30 weeks depending on the duration of rehabilitation coverage.)
  • Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.(4 to 30 weeks depending on the duration of rehabilitation coverage.)

Study Sites (1)

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