Aerobic Exercise to Improve Memory in TBI

September 30, 2013 updated by: Victoria Leavitt, Kessler Foundation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic exercise
30 minutes x 3 times/week x 12 weeks of stationery cycling
Behavioral: Aerobic exercise
Placebo Comparator: Non-aerobic exercise
30 minutes x 3 times/week x 12 weeks of gentle non-aerobic stretching
Behavioral: Placebo control
Non-aerobic stretching sessions will be conducted 3x/week for 30 minutes over 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hippocampal volume
Time Frame: 1 week post intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

New Jersey Commission on Brain Injury Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 30, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-687-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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