Exercise in Gulf War Illness (GWI)

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
James Baraniuk, MD, Georgetown University
ClinicalTrials.gov Identifier:
NCT01291758
First received: February 7, 2011
Last updated: February 24, 2014
Last verified: February 2014
  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:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • To assess the alterations due to exercise in Gulf War Veterans [ Time Frame: 02/2009-09/2012 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Enrollment: 50
Study Start Date: July 2009
Study Completion Date: September 2012
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

Locations
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
Investigators
Principal Investigator: James N Baraniuk, MD Georgetown University
  More Information

Additional Information:
Publications:

Responsible Party: James Baraniuk, MD, Professor of Medicine, 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 24, 2014
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 April 17, 2014