Exercise in Gulf War Illness (GWI)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by Georgetown University.
Recruitment status was Recruiting

Sponsor:

Collaborator:

U.S. Army Medical Research and Materiel Command

Information provided by:

Georgetown University

ClinicalTrials.gov Identifier:

NCT01291758

First received: February 7, 2011

Last updated: NA

Last verified: February 2011

History: No changes posted

Purpose

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
Gulf War Illness Persian Gulf Syndrome

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Georgetown University:

Biospecimen Retention: Samples With DNA

Plasma, serum, urine, cerebrospinal fluid (CSF), and buccal swab samples retained for testing as described in protocol.

Estimated Enrollment:	80
Study Start Date:	July 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
GWI Veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
HC Healthy veterans of the 1990-1991 Persian Gulf War

Eligibility

Ages Eligible for Study:	38 Years to 86 Years
Genders Eligible for Study:	Both
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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291758

Contacts

Contact: Yin Zheng, MS	202-687-8231	gwiresearch@georgetown.edu
Contact: Christian R Timbol, MS	202-687-8231	gwiresearch@georgetown.edu

Locations

United States, District of Columbia
Georgetown University	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Yin Zheng, MS 202-687-8231 gwiresearch@georgetown.edu
Contact: Christian R Timbol, MS 202-687-8231 gwiresearch@georgetown.edu
Principal Investigator: James N Baraniuk, MD

Sponsors and Collaborators

Georgetown University

U.S. Army Medical Research and Materiel Command

Investigators

Principal Investigator:

James N Baraniuk, MD

Georgetown University

More Information

Additional Information:

Laboratory Website This link exits the ClinicalTrials.gov site

Publications:

Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastañaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. Erratum in: Am J Epidemiol. 2005 Feb 1;161(3):302.

Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22.

Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Köppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7.

Casado B, Zanone C, Annovazzi L, Iadarola P, Whalen G, Baraniuk JN. Urinary electrophoretic profiles from chronic fatigue syndrome and chronic fatigue syndrome/fibromyalgia patients: a pilot study for achieving their normalization. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Jan 5;814(1):43-51.

Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8.

Responsible Party:	James N. Baraniuk, MD, Georgetown University
ClinicalTrials.gov Identifier:	NCT01291758 History of Changes
Other Study ID Numbers:	2009-229, USAMRMC PR# W81XWH-09-1-0526, HRPO Log No. A-15547
Study First Received:	February 7, 2011
Last Updated:	February 7, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Georgetown University:

Persian Gulf War
Gulf War Syndrome
GWI
Gulf War Illness
Exercise
Chronic Fatigue

Fibromyalgia
Veterans
Irritable Bowel Syndrome
Migraine headaches
Neuropathy

Additional relevant MeSH terms:

Persian Gulf Syndrome
Occupational Diseases

ClinicalTrials.gov processed this record on May 16, 2013

To Top