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Trial record 23 of 315 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Aerobic Exercise (AER) Other: Rehabilitation Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Official Title: Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
Study Start Date : June 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.

No Intervention: control (C)
Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. 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 Outcome Measures :
  1. 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.

  2. Aerobic Exercise Induced Changes in Depression Symptoms [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
    Beck Depression Inventory


Other Outcome Measures:
  1. Verbal Memory [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
    California Verbal Learning Test (CVLT II).

  2. Visual Search/Processing Speed [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
    Trail Making

  3. Quality of Life [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
    Quality of Life in Neurological Disorders (Neuro-QoL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407924


Contacts
Contact: Grace S Griesbach, PhD (818)783-3800 researchcentre@neuroskills.com
Contact: Lisa Kreber, PhD (661)873-6513 researchcentre@neuroskills.com

Locations
United States, California
Centre for Neuro Skills Recruiting
Encino, California, United States, 91436
Contact: Grace Griesbach, PhD    818-783-3800    researchcentre@neuroskills.com   
Contact: Charan Singh, MS    (661)872-3408    csingh@neuroskills.com   
Sponsors and Collaborators
Centre for Neuro Skills
Investigators
Principal Investigator: Grace S Griesbach, PhD Centre for Neuro Skills

Publications:

Responsible Party: Grace S. Griesbach, National Director of Clinical Research, Centre for Neuro Skills
ClinicalTrials.gov Identifier: NCT03407924     History of Changes
Other Study ID Numbers: AER-TBI1
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System