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Exercise and Rehabilitation After Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise (AER)
Rehabilitation
Sponsored by
Centre for Neuro Skills
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre for Neuro SkillsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Intervention aerobic exercise (AER)

rehabilitation (R)

control (C)

Arm Description

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.

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.

Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects.

Outcomes

Primary Outcome Measures

Aerobic Exercise Induced Changes in Inflammatory responses to exercise
Selected analytes will be evaluated from serum.
Aerobic Exercise Induced Changes in Cognitive Function
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
Ventilatory Threshold (aerobic capacity)
Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise
Selected analytes will be evaluated from serum.

Secondary Outcome Measures

Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.
Genetic material will be obtained.
Aerobic Exercise Induced Changes in Depression Symptoms
Beck Depression Inventory

Full Information

First Posted
July 9, 2015
Last Updated
January 26, 2018
Sponsor
Centre for Neuro Skills
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1. Study Identification

Unique Protocol Identification Number
NCT03407924
Brief Title
Exercise and Rehabilitation After Traumatic Brain Injury
Official Title
Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Neuro Skills

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Intervention will consist of aerobic exercise sessions at predetermined heart rate range.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention aerobic exercise (AER)
Arm Type
Experimental
Arm Description
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.
Arm Title
rehabilitation (R)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control (C)
Arm Type
No Intervention
Arm Description
Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise (AER)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aerobic Exercise Induced Changes in Inflammatory responses to exercise
Description
Selected analytes will be evaluated from serum.
Time Frame
4 to 30 weeks depending on the duration of rehabilitation coverage.
Title
Aerobic Exercise Induced Changes in Cognitive Function
Description
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.
Time Frame
5 years
Title
Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness
Description
Ventilatory Threshold (aerobic capacity)
Time Frame
4 to 30 weeks depending on the duration of rehabilitation coverage.
Title
Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise
Description
Selected analytes will be evaluated from serum.
Time Frame
4 to 30 weeks depending on the duration of rehabilitation coverage.
Secondary Outcome Measure Information:
Title
Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.
Description
Genetic material will be obtained.
Time Frame
4 to 30 weeks depending on the duration of rehabilitation coverage.
Title
Aerobic Exercise Induced Changes in Depression Symptoms
Description
Beck Depression Inventory
Time Frame
4 to 30 weeks depending on the duration of rehabilitation coverage.
Other Pre-specified Outcome Measures:
Title
Verbal Memory
Description
California Verbal Learning Test (CVLT II).
Time Frame
4 to 30 weeks depending on the duration of rehabilitation coverage.
Title
Visual Search/Processing Speed
Description
Trail Making
Time Frame
4 to 30 weeks depending on the duration of rehabilitation coverage.
Title
Quality of Life
Description
Quality of Life in Neurological Disorders (Neuro-QoL)
Time Frame
4 to 30 weeks depending on the duration of rehabilitation coverage.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace S Griesbach, PhD
Phone
(818)783-3800
Email
researchcentre@neuroskills.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Kreber, PhD
Phone
(661)873-6513
Email
researchcentre@neuroskills.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace S Griesbach, PhD
Organizational Affiliation
Centre for Neuro Skills
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Neuro Skills
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Griesbach, PhD
Phone
818-783-3800
Email
researchcentre@neuroskills.com
First Name & Middle Initial & Last Name & Degree
Charan Singh, MS
Phone
(661)872-3408
Email
csingh@neuroskills.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15051152
Citation
Griesbach GS, Hovda DA, Molteni R, Wu A, Gomez-Pinilla F. Voluntary exercise following traumatic brain injury: brain-derived neurotrophic factor upregulation and recovery of function. Neuroscience. 2004;125(1):129-39. doi: 10.1016/j.neuroscience.2004.01.030.
Results Reference
background
PubMed Identifier
10462147
Citation
Hellawell DJ, Taylor RT, Pentland B. Cognitive and psychosocial outcome following moderate or severe traumatic brain injury. Brain Inj. 1999 Jul;13(7):489-504. doi: 10.1080/026990599121403.
Results Reference
background
PubMed Identifier
17195886
Citation
Ashman TA, Gordon WA, Cantor JB, Hibbard MR. Neurobehavioral consequences of traumatic brain injury. Mt Sinai J Med. 2006 Nov;73(7):999-1005.
Results Reference
background
PubMed Identifier
20588094
Citation
Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
Results Reference
background
PubMed Identifier
15468028
Citation
Chamelian L, Feinstein A. Outcome after mild to moderate traumatic brain injury: the role of dizziness. Arch Phys Med Rehabil. 2004 Oct;85(10):1662-6. doi: 10.1016/j.apmr.2004.02.012.
Results Reference
background
PubMed Identifier
24378157
Citation
Agrawal M, Joshi M. Impact of rehabilitation on functional outcome during the first year of moderate and severe traumatic brain injury. Brain Inj. 2014;28(3):292-7. doi: 10.3109/02699052.2013.865266. Epub 2013 Dec 30.
Results Reference
background
PubMed Identifier
25496475
Citation
Griesbach GS, Kreber LA, Harrington D, Ashley MJ. Post-acute traumatic brain injury rehabilitation: effects on outcome measures and life care costs. J Neurotrauma. 2015 May 15;32(10):704-11. doi: 10.1089/neu.2014.3754. Epub 2015 Feb 11.
Results Reference
background
PubMed Identifier
23648599
Citation
Chandrasekhar SS. The assessment of balance and dizziness in the TBI patient. NeuroRehabilitation. 2013;32(3):445-54. doi: 10.3233/NRE-130867.
Results Reference
background
PubMed Identifier
19131578
Citation
Ridgel AL, Vitek JL, Alberts JL. Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):600-8. doi: 10.1177/1545968308328726. Epub 2009 Jan 8.
Results Reference
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Exercise and Rehabilitation After Traumatic Brain Injury

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