Aerobic Exercise to Improve Memory in TBI

NCT01952704 | Unknown DMC

• 1 other identifier: R-687-11
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Hippocampal volume

  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

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

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

Behavioral: Aerobic exercise

Non-aerobic exercise

PLACEBO COMPARATOR

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

Behavioral: Placebo control

Interventions

Aerobic exercise BEHAVIORAL

Aerobic exercise

Placebo control BEHAVIORAL

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

Non-aerobic exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• TBI greater than or equal to 1 year
• MRI compatibility
• Right Handed

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead
• New Jersey Commission on Brain Injury Research: collaborator

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 30, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 1, 2013

Record last verified: 2013-09