Aerobic Exercise to Improve Memory in TBI

NCT ID: NCT01952704

Last Updated: 2013-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-05-31

Brief Summary

Aerobic exercise holds a multitude of health benefits. Studies in mice have shown that aerobic exercise improves memory, and increases the volume of the hippocampus, the brain's primary memory center. Only two studies have been conducted in humans, one in healthy elders, and the other in a schizophrenia population. So far, there has never been an aerobic exercise trial in traumatic brain injury (TBI) to look at hippocampal volume and memory as outcomes of interest. The proposed project is a randomized controlled trial of aerobic exercise in persons with TBI. We will conduct a 12-week (36 sessions) program of aerobic exercise (stationary cycling), versus a control condition of non-aerobic exercise (stretching), in memory-impaired TBI patients to a) increase hippocampal volume and b) improve memory. Importantly, we also expect benefits of aerobic exercise on the level of brain function. Specifically, we will look at 'functional connectivity,' which refers to how efficiently remote regions of the brain 'talk' to each other. TBI is an ideal population to benefit from aerobic exercise, given the young age at which many individuals sustain TBI, which allows for benefits of aerobic exercise to be maximally realized in a population with sufficient neurofunctional reserve. The expected benefits of aerobic exercise (increased hippocampal volume, improved memory) from this intervention stand to have a meaningful impact on people with TBI, including improved health, productivity, independence, and quality of life. And, unlike current treatments for memory impairment (e.g., pharmacological agents, cognitive rehabilitation), aerobic exercise is a cost-effective, all natural, readily-available treatment for memory problems.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Aerobic exercise

30 minutes x 3 times/week x 12 weeks of stationery cycling

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: BEHAVIORAL

Non-aerobic exercise

30 minutes x 3 times/week x 12 weeks of gentle non-aerobic stretching

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: BEHAVIORAL

Non-aerobic stretching sessions will be conducted 3x/week for 30 minutes over 12 weeks.

Interventions

Aerobic exercise

Intervention Type: BEHAVIORAL

Placebo control

Non-aerobic stretching sessions will be conducted 3x/week for 30 minutes over 12 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• TBI greater than or equal to 1 year
• MRI compatibility
• Right Handed

Exclusion Criteria

• Reported lower body weakness or use of an assistive device for walking
• History of pulmonary disease, heart disease, vascular disease of the legs, high blood pressure
• History of stroke, other neurological disease/disorder, serious psychiatric illness
• Engaging in more than 30 minutes of aerobic exercise per week
• Current use of steroids, benzodiazepines, and/or neuroleptics
• History of substance abuse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Jersey Commission on Brain Injury Research

OTHER

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Victoria Leavitt

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

R-687-11

Identifier Type: -

Identifier Source: org_study_id