Exercise in Gulf War Illness (GWI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01291758
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : February 25, 2014
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
James Baraniuk, MD, Georgetown University

Brief Summary:
The purpose of this study is to determine if submaximal exercise by bicycle stress tests with pulmonary measurement of VO2MAX plus maximal isometric hand grips on 2 consecutive days causes a higher level of "exertional exhaustion" in GWI compared to healthy veterans (HVets).

Condition or disease
Gulf War Illness Persian Gulf Syndrome

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : July 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
Healthy veterans of the 1990-1991 Persian Gulf War

Primary Outcome Measures :
  1. To assess the alterations due to exercise in Gulf War Veterans [ Time Frame: 02/2009-09/2012 ]

Biospecimen Retention:   Samples With DNA
Plasma, serum, urine, cerebrospinal fluid (CSF), and buccal swab samples retained for testing as described in protocol.

Information from the National Library of Medicine

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Ages Eligible for Study:   38 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All veterans who served in the Armed Forces between August 1990 and July 1991

Inclusion Criteria:

  • Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:

    • Persian Gulf waters and adjacent land areas
    • Other global locations
    • U.S. only
  • Status prior to 1990 and 1991:

    • Active duty
    • National Guard
    • Reserves

Exclusion Criteria:

  • Current active duty military personnel
  • Any one who was not active duty military personnel between August 1, 1990 and July 31, 1991
  • HIV/AIDS; pregnancy or lactation; potential hepatitis; drug addiction; chronic inflammatory, infectious, or autoimmune medical illnesses not associated with GWI; incarceration; dementia, other cognitive limitation; or reliance on a care-giver in order to respond to the questionnaires and other study tests.

Amputations of one or both hands and forearms will be permitted but hand grip tests will not be tested

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01291758

United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
U.S. Army Medical Research and Materiel Command
Principal Investigator: James N Baraniuk, MD Georgetown University

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: James Baraniuk, MD, Professor of Medicine, Georgetown University Identifier: NCT01291758     History of Changes
Other Study ID Numbers: 2009-229
USAMRMC PR# W81XWH-09-1-0526
HRPO Log No. A-15547
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

Keywords provided by James Baraniuk, MD, Georgetown University:
Persian Gulf War
Gulf War Syndrome
Gulf War Illness
Chronic Fatigue
Irritable Bowel Syndrome
Migraine headaches

Additional relevant MeSH terms:
Persian Gulf Syndrome
Pathologic Processes
Occupational Diseases