The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

NCT00940615 | Terminated

• 1 other identifier: B6859-M
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The current project will examine the effects of aerobic exercise on cognition among a group of veterans who have suffered a mild traumatic brain injury.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; aerobic exercise; Diffusion Tensor Imaging; Neuropsychology; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Diffusion Tensor Imaging

  16 weeks

Secondary Outcomes (14)

• Trail Making Test - Part A

  16 weeks

• Symbol Search

  16 weeks

• California Verbal Learning Test - Second Edition (CVLT-II).

  16 weeks

• Brief Visual Memory Test - Revised (BVMT-R).

  16 weeks

• Adaptive Digit Ordering Test (DOT-A).

  16 weeks

Study Arms (2)

1

EXPERIMENTAL

participants in the aerobic exercise intervention

Other: aerobic exercise

2

ACTIVE COMPARATOR

participants in the stretching/toning control condition

Other: stretching/toning

Interventions

aerobic exercise OTHER

, participants assigned to the exercise treatment group of the proposed study will participate in an aerobic exercise regimen of brisk walking on a treadmill for a 60 minute interval, three times a week

1

stretching/toning OTHER

Individuals in the control group will participate in a low intensity stretching and toning session for 60 minutes, three times a week

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Anyone between 18 and 50 years of age,
• from the geographic region served by the Malcolm Randall-North Florida-South Georgia VAMC,
• who have sustained a TBI and demonstrate impairment on neuropsychological assessment (criteria for mTBI will be defined as a loss of consciousness for not more than 30 minutes and post-trauma amnesia of not more than 24 hours).

You may not qualify if:

• TBI occurring less than 6 months or greater than 5 years prior to enrollment,
• any metal implants or shrapnel that may put them at risk for injury during an MRI scan,
• significant cognitive impairment (MMSE\<24),
• history of stroke,
• B-12 deficiency,
• hypothyroidism,
• organ failure (renal, hepatic, cardiac, or lung),
• substance abuse,
• seizures,
• or any limitation that would preclude them from safely engaging in the aerobic exercise regimen.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Exercise

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

Study Officials

• David E Cox, PhD

  North Florida/South Georgia Veterans Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 16, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

US (1)