Exercise and Rehabilitation After Traumatic Brain Injury

Centre for Neuro Skills (CNS)

Status and phase: Unknown; Phase 1

Conditions: Traumatic Brain Injury

Treatments: Other: Rehabilitation; Other: Aerobic Exercise (AER)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03407924

AER-TBI1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Intervention aerobic exercise (AER)

Experimental group

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.

Treatment:

Other: Rehabilitation

Other: Aerobic Exercise (AER)

rehabilitation (R)

Active Comparator group

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.

Treatment:

Other: Rehabilitation

control (C)

No Intervention group

Description:

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