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
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
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
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
NCT ID
NCT01952704
First Posted
September 24, 2013
Last Updated
September 30, 2013
Sponsor
Kessler Foundation
Collaborators
New Jersey Commission on Brain Injury Research
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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