Exercise and Rehabilitation After Traumatic Brain Injury

NCT03407924 | Unknown Phase 1

• 1 other identifier: AER-TBI1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• Aerobic Exercise Induced Changes in Inflammatory responses to exercise

  Selected analytes will be evaluated from serum.

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

• 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.

  5 years

• Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness

  Ventilatory Threshold (aerobic capacity)

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

• Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise

  Selected analytes will be evaluated from serum.

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

Secondary Outcomes (2)

• Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.

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

• Aerobic Exercise Induced Changes in Depression Symptoms

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

Other Outcomes (3)

• Verbal Memory

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

• Visual Search/Processing Speed

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

• Quality of Life

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

Study Arms (3)

Intervention aerobic exercise (AER)

EXPERIMENTAL

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); Other: Rehabilitation

rehabilitation (R)

ACTIVE COMPARATOR

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

control (C)

NO INTERVENTION

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

Interventions

Aerobic Exercise (AER) OTHER

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 aerobic exercise (AER)

Rehabilitation OTHER

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.

Intervention aerobic exercise (AER); rehabilitation (R)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Neuro Skills: lead

Study Sites (1)

Centre for Neuro Skills

Encino, California, 91436, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 15051152 BACKGROUND

• 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.

  PMID: 10462147 BACKGROUND

• Ashman TA, Gordon WA, Cantor JB, Hibbard MR. Neurobehavioral consequences of traumatic brain injury. Mt Sinai J Med. 2006 Nov;73(7):999-1005.

  PMID: 17195886 BACKGROUND

• 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.

  PMID: 20588094 BACKGROUND

• 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.

  PMID: 15468028 BACKGROUND

• 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.

  PMID: 24378157 BACKGROUND

• 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.

  PMID: 25496475 BACKGROUND

• Chandrasekhar SS. The assessment of balance and dizziness in the TBI patient. NeuroRehabilitation. 2013;32(3):445-54. doi: 10.3233/NRE-130867.

  PMID: 23648599 BACKGROUND

• 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.

  PMID: 19131578 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Exercise; Rehabilitation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Grace S Griesbach, PhD

  Centre for Neuro Skills

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace S Griesbach, PhD

CONTACT

(818)783-3800; researchcentre@neuroskills.com

Lisa Kreber, PhD

CONTACT

(661)873-6513; researchcentre@neuroskills.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Director of Clinical Research

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

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: January 23, 2018
• Study Start: June 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2022
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

US (1)