Exercise and Rehabilitation After Traumatic Brain Injury

Phase 1

• Conditions: Traumatic Brain Injury
• Interventions: Other: Rehabilitation; Other: Aerobic Exercise (AER)

• Registration Number: NCT03407924
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-07-09
• Study Start: 2016-06
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-23
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-30
• Primary Completion: 2020-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rehabilitation (R)	Rehabilitation	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 aerobic exercise (AER)	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.
Intervention aerobic exercise (AER)	Rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Aerobic Exercise Induced Changes in Inflammatory responses to exercise	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	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	4 to 30 weeks depending on the duration of rehabilitation coverage.	Ventilatory Threshold (aerobic capacity)
Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise	4 to 30 weeks depending on the duration of rehabilitation coverage.	Selected analytes will be evaluated from serum.

Secondary Outcome Measures

Name	Time	Method
Aerobic Exercise Induced Changes in Depression Symptoms	4 to 30 weeks depending on the duration of rehabilitation coverage.	Beck Depression Inventory
Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.	4 to 30 weeks depending on the duration of rehabilitation coverage.	Genetic material will be obtained.

Trial Locations

Locations (1)

Centre for Neuro Skills; 🇺🇸 Encino, California, United States