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Aerobic Exercise to Improve Memory in TBI

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01952704
Enrollment
24
Registered
2013-09-30
Start date
2013-10-31
Completion date
2015-05-31
Last updated
2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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.

Interventions

BEHAVIORALAerobic exercise
BEHAVIORALPlacebo control

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

Sponsors

New Jersey Commission on Brain Injury Research
CollaboratorOTHER
Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hippocampal volume1 week post interventionVolumetric software will be used to measure hippocampus at baseline and follow-up (within 1 week of completion of 12-week intervention).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026