Aerobic Exercise After Traumatic Brain Injury (AER-TBI1)

Centre for Neuro Skills (CNS)

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Traumatic Brain Injury

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05786729

Pro00016168

Details and patient eligibility

About

The purpose of this study is to examine the effects of individualized aerobic exercise regimen on recovery after traumatic brain injury (TBI).Investigators will determine if exercise facilitates recovery by facilitating neuroplasticity and decreasing neuroinflammation.

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, and inflammation influence the responsiveness to exercise and rehabilitation. Recovery will be determined by assessing cognitive function, life quality and balance.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All participants will provide informed consent and have to comply with the procedures of the study.
• Age will range from 18 to 60 years.
• Except for the non-injured control group, subjects will be required to have experienced TBI.
• All participants should be fluent in English or Spanish.
• All participants should have the ability to comply with the research protocol.
• Capable of exercising in aerobic exercise equipment (with or without trunk support).
• Able to walk independently with or without a device

Exclusion criteria

• Current diagnosis of degenerative neurological disease.
• A history of cerebral vascular accidents.
• A history of major psychosis as defined by DSM-IV.
• Subjects receiving physical therapy in a location that is not CNS.
• Pregnancy.
• A history of previous TBI requiring hospitalization.
• Inability to cooperate
• Orthopedic impairment that compromises exercise performance
• Any cardiovascular or respiratory condition that jeopardizes patient health during exercise.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 3 patient groups

Intervention Aerobic Exercise (AER)

Experimental group

Description:

Consented participants will be randomly assigned to aerobic exercise regimen (AER) + Standard Rehabilitation(R+AER) or Standard Rehabilitation only (R) group. In order to determine the necessary time window for AER exercise treatment, TBI subjects will partake in supervised AER sessions for a period of 12 weeks. After a baseline evaluations follow-ups will take place at take place at weeks 4, 8 and 12. Thus each participants will be evaluated 4 times.

Treatment:

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 12 weeks. Activity levels will be monitored.

Treatment:

Other: Rehabilitation

Control (C)

No Intervention group

Description:

Healthy volunteers' responsiveness to exercise will be compared to TBI responsiveness.