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Aerobic Exercise to Improve Memory in TBI

Primary Purpose

Traumatic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic exercise
Placebo control
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Aerobic exercise

    Non-aerobic exercise

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Hippocampal volume
    Volumetric software will be used to measure hippocampus at baseline and follow-up (within 1 week of completion of 12-week intervention).

    Secondary Outcome Measures

    Full Information

    First Posted
    September 24, 2013
    Last Updated
    September 30, 2013
    Sponsor
    Kessler Foundation
    Collaborators
    New Jersey Commission on Brain Injury Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01952704
    Brief Title
    Aerobic Exercise to Improve Memory in TBI
    Official Title
    A Randomized Controlled Trial of Aerobic Exercise to Improve Memory in TBI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    May 2015 (Anticipated)
    Study Completion Date
    May 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kessler Foundation
    Collaborators
    New Jersey Commission on Brain Injury Research

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aerobic exercise
    Arm Type
    Experimental
    Arm Description
    30 minutes x 3 times/week x 12 weeks of stationery cycling
    Arm Title
    Non-aerobic exercise
    Arm Type
    Placebo Comparator
    Arm Description
    30 minutes x 3 times/week x 12 weeks of gentle non-aerobic stretching
    Intervention Type
    Behavioral
    Intervention Name(s)
    Aerobic exercise
    Intervention Type
    Behavioral
    Intervention Name(s)
    Placebo control
    Intervention Description
    Non-aerobic stretching sessions will be conducted 3x/week for 30 minutes over 12 weeks.
    Primary Outcome Measure Information:
    Title
    Hippocampal volume
    Description
    Volumetric software will be used to measure hippocampus at baseline and follow-up (within 1 week of completion of 12-week intervention).
    Time Frame
    1 week post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Aerobic Exercise to Improve Memory in TBI

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