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Exercise and Rehabilitation After Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03407924
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Grace S. Griesbach, Centre for Neuro Skills

July 9, 2015
January 23, 2018
January 30, 2018
June 2016
March 2020   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT03407924 on ClinicalTrials.gov Archive Site
  • Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise. [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
    Genetic material will be obtained.
  • Aerobic Exercise Induced Changes in Depression Symptoms [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
    Beck Depression Inventory
Same as current
  • Verbal Memory [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
    California Verbal Learning Test (CVLT II).
  • Visual Search/Processing Speed [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
    Trail Making
  • Quality of Life [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
    Quality of Life in Neurological Disorders (Neuro-QoL)
Same as current
 
Exercise and Rehabilitation After Traumatic Brain Injury
Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Intervention will consist of aerobic exercise sessions at predetermined heart rate range.
Masking: None (Open Label)
Primary Purpose: Treatment
Traumatic Brain Injury
  • Other: Aerobic Exercise (AER)
    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.
  • Other: Rehabilitation
    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.
  • Experimental: Intervention aerobic exercise (AER)
    Participants with traumatic brain injury (TBI) that are enrolled in a comprehensive rehabilitation program (R) will be engaged in an aerobic exercise program (AER). These participants will also receive standard rehabilitation which includes exercise within the physical therapy session. Given that the duration of the rehabilitative program is variable the period of AER training will be no less than 4 weeks and will not exceed 30 weeks. Activity levels will be monitored.
    Interventions:
    • Other: Aerobic Exercise (AER)
    • Other: Rehabilitation
  • Active Comparator: rehabilitation (R)
    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 30 weeks. Activity levels will be monitored.
    Intervention: Other: Rehabilitation
  • No Intervention: control (C)
    Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Same as current
March 2022
March 2020   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact: Grace S Griesbach, PhD (818)783-3800 researchcentre@neuroskills.com
Contact: Lisa Kreber, PhD (661)873-6513 researchcentre@neuroskills.com
United States
 
 
NCT03407924
AER-TBI1
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Grace S. Griesbach, Centre for Neuro Skills
Centre for Neuro Skills
Not Provided
Principal Investigator: Grace S Griesbach, PhD Centre for Neuro Skills
Centre for Neuro Skills
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP