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Trial record 8 of 109 for:    Exercise | TBI (Traumatic Brain Injury)

Aerobic Exercise to Improve Memory in TBI

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ClinicalTrials.gov Identifier: NCT01952704
Recruitment Status : Unknown
Verified September 2013 by Victoria Leavitt, Kessler Foundation.
Recruitment status was:  Not yet recruiting
First Posted : September 30, 2013
Last Update Posted : October 1, 2013
Sponsor:
Collaborator:
New Jersey Commission on Brain Injury Research
Information provided by (Responsible Party):
Victoria Leavitt, Kessler Foundation

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Aerobic exercise Behavioral: Placebo control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Aerobic Exercise to Improve Memory in TBI
Study Start Date : October 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Victoria Leavitt, Research Scientist, Kessler Foundation
ClinicalTrials.gov Identifier: NCT01952704     History of Changes
Other Study ID Numbers: R-687-11
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries