Exercise in Gulf War Illness (GWI)

Georgetown University

Status: Completed

Conditions: Persian Gulf Syndrome; Gulf War Illness

Treatments: Diagnostic Test: Submaximal bicycle exercise stress tests performed 24 hr apart

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01291758

USAMRMC PR# W81XWH-09-1-0526 (Other Grant/Funding Number)

2009-229

HRPO Log No. A-15547 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 38 to 86 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

GWI

Description:

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

Treatment:

Diagnostic Test: Submaximal bicycle exercise stress tests performed 24 hr apart

HC

Description:

Healthy veterans of the 1990-1991 Persian Gulf War

Treatment:

Diagnostic Test: Submaximal bicycle exercise stress tests performed 24 hr apart