Aerobic Exercise to Improve Memory in TBI

Traumatic Brain Injury Clinical Trial

Official title:

A Randomized Controlled Trial of Aerobic Exercise to Improve Memory in TBI

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01952704
• Other study ID #: R-687-11
• Status: Not yet recruiting
• Phase: N/A
• First received: September 24, 2013
• Last updated: September 30, 2013
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2013
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Traumatic Brain Injury

Intervention

Behavioral:
• Aerobic exercise

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	New Jersey Commission on Brain Injury Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hippocampal volume	Volumetric software will be used to measure hippocampus at baseline and follow-up (within 1 week of completion of 12-week intervention).	1 week post intervention	No