Effects of Exercise on Memory in Healthy and Brain-Injured Individuals

NCT01939769 | Terminated Phase 1

• 2 other identifiers: 13019813-N-0198
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Research has shown that one exercise session may improve a person s ability to recall information they learned before the exercise. Knowing how exercise changes brain activity to improve memory can help researchers understand how memory works and how to improve it in people with memory problems. This study compares two kinds of exercise on a stationary bike for their ability to temporarily improve memory on certain tests. Researchers will look at the effect of exercise on body chemistry by drawing blood and collecting saliva. Objectives: \- To understand how a single session of exercise affects memory testing in healthy people and people who have had traumatic brain injury (TBI). Eligibility:

• Adults ages 18 through 45 with TBI.
• Healthy adult volunteers, ages 18 through 45. Design:
• Participants will be screened with medical history and physical exam. This will take about 1 hour.
• Participants with TBI will also be screened with a test of their memory. This will take another hour.
• Visit 1 will take about 3 hours. Participants will: \<TAB\>- Have a tube inserted in their arm for drawing blood during the tests. \<TAB\>- Take memory tests. They will look at pictures, symbols, and words, then answer questions. \<TAB\>- Give a saliva sample by chewing on a small sponge for 2 minutes. \<TAB\>- Exercise on a stationary bike. \<TAB\>- Take the memory tests again. \- Visit 2 will take place 1 week later. Participants will take the memory tests only.

Conditions

Traumatic Brain Injury

Keywords

fMRI; Catecholamines; Stress; Exercise; Memory

Outcome Measures

Primary Outcomes (1)

• Recall of pictures

  2 years

Secondary Outcomes (2)

• Recall of word lists

  2 years

• Digit-symbol substitution performance

  2 years

Interventions

Exercise - Low-intensity exercise OTHER

Exercise - High-intensity exercise OTHER

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \<TAB\>
• Age 18-45 (inclusive)
• English speaking and writing
• For TBI patients:\<TAB\>
• History of TBI (defined according to the American Congress of Rehabilitation Medicine Criteria: History of having sustained a traumatically induced physiological disruption of brain function at least 2 months before participation)
• Evidence of at least moderate TBI severity. Evidence for intensity of TBI will be any one of the following 3 criteria:
• GCS greater than or equal to 9 (obtained in Emergency Room and noted in medical record)
• Post-traumatic amnesia \> 24 hours
• TBI-related abnormality on neuroimaging (either CT or MRI)
• Documented memory deficit, i.e., a score of 1 standard deviation or more below age-adjusted norm on a recognized clinical test of memory, such as the Wexler Memory Scale, within the last two years.
• Enrollment in Protocol 11-N-0084
• Right-handedness for fMRI participants

You may not qualify if:

• Inability to give informed consent
• History of major neurological or psychiatric illness, e.g., neurodegenerative disorder, stroke, congenital or genetic disorder, currently symptomatic major depressive disorder, schizophrenia
• History of exercise intolerance
• Any finding on examination indicative of cardiac or respiratory compromise
• History of heart disease
• History of pulmonary disease, other than controlled, non-exercise-induced asthma
• History of uncontrolled diabetes
• Resting heart rate \> 100 BPM
• Resting systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 100 mmHg
• Peripheral condition making completion of the exercise protocol impossible, such as severe osteoarthritis or chronic pain
• Pregnancy
• For healthy subjects undergoing MRI:
• Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, or ocular foreign body
• Implanted cardiac pacemaker or auto-defibrillator or pump
• Non-removable body piercing

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Ahlskog JE, Geda YE, Graff-Radford NR, Petersen RC. Physical exercise as a preventive or disease-modifying treatment of dementia and brain aging. Mayo Clin Proc. 2011 Sep;86(9):876-84. doi: 10.4065/mcp.2011.0252.

  PMID: 21878600 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.

  PMID: 5523831 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eric M Wassermann, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 11, 2013
• Study Start: August 31, 2013
• Primary Completion: May 21, 2015
• Study Completion: August 28, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08-28

Locations

US (1)