The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury

University of Florida

Status: Completed

Conditions: Brain Concussion

Treatments: Behavioral: Non-Aerobic Exercise; Behavioral: Aerobic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02276079

IRB201400882

Details and patient eligibility

About

The study is a "proof-of-principle" project to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). The study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor [BDNF] concentration).

Full description

This is a "proof-of-principle" project for human subjects to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). This study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor [BDNF] concentration). This project will also lay the foundation for understanding the relationship between exercise and BDNF in the area of mTBI neurorecovery, thereby allowing future studies to develop best-practice methods for implementing exercise interventions as a treatment option for brain injuries.

Enrollment: 39 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Mild traumatic brain injury (mTBI) group:

Inclusion Criteria:

• Meet criteria for mTBI as set forth by the American Congress of Rehabilitation Medicine
• mTBI was sustained 14-25 days before beginning the exercise intervention

Exclusion Criteria:

• comorbid orthopaedic injury that inhibits movement
• history of serious psychiatric disturbance with hospitalization,
• prior history of neurologic disease,
• current or past history of substance abuse disorder,
• diabetes
• previous history of moderate or severe head injury,
• neurological disorder unrelated to TBI (e.g., seizure disorder)
• physician recommendations against exercise
• non-English speakers

Non-injured Group:

Inclusion Criteria:

• Gainesville, Florida community member

Exclusion Criteria:

• History of mTBI or other brain injury in the past year
• comorbid orthopaedic injury that inhibits movement
• history of serious psychiatric disturbance with hospitalization,
• prior history of neurologic disease,
• current or past history of substance abuse disorder,
• diabetes
• previous history of moderate or severe head injury,
• neurological disorder unrelated to TBI (e.g., seizure disorder)
• physician recommendations against exercise
• non-English speakers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

39 participants in 3 patient groups

mTBI Aerobic Exercise Group

Experimental group

Description:

Participants are two-three weeks post-mild traumatic brain injury are randomized to receive a daily aerobic exercise intervention lasting 1-week.

Treatment:

Behavioral: Aerobic Exercise

mTBI Non-Aerobic Exercise Group

Experimental group

Description:

Participants are two-three weeks post-mild traumatic brain injury are randomized to receive a daily non-aerobic exercise intervention lasting 1-week.

Treatment:

Behavioral: Non-Aerobic Exercise

Non-injured Reference Group

No Intervention group

Description:

Non-injured, healthy participants will serve as a reference group for functional outcome measures.