Exercise in Gulf War Illness (GWI)

Completed

• Conditions: Gulf War Illness; Persian Gulf Syndrome
• Interventions: Diagnostic Test: Submaximal bicycle exercise stress tests performed 24 hr apart

• Registration Number: NCT01291758
• Lead Sponsor: 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).

Detailed Description

Subjects sat on upright bicycles for preexercise symptoms, respiratory gases, EKG, and vital sign measurements.

Submaximal exercise began at low resistance with increases every 30 to 60 seconds until 70% predicted heart rate was reached by 5 minutes. Subjects maintained their pace until 25 minutes, then resistance was increased incrementally to increase to 85% predicted heart rate (approximately sufficient to reach anaerobic threshold).

Symptoms, respiratory gases, EKG, and vital signs were measured every 5 minutes, at peak of exercise, and 5 minute intervals after exercise.

The identical exercise protocol was used approximately 24 hr later. Secondary outcomes were assessed by comparisons from before exercise to after the second bicycle exercise stress test.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GWI	Submaximal bicycle exercise stress tests performed 24 hr apart	Veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
HC	Submaximal bicycle exercise stress tests performed 24 hr apart	Healthy veterans of the 1990-1991 Persian Gulf War

Primary Outcome Measures

Name	Time	Method
To assess the alterations due to exercise in Gulf War Veterans	02/2009-09/2012	Difference in duration of exercise between first and second submaximal bicycle exercise stress test

Trial Locations

Locations (1)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States