Exercise in Gulf War Illness (GWI)

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).

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Key information

Conditions

Gulf War Illness Behavior Brain Diseases Central Nervous System Diseases Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Fibromyalgia Gastrointestinal Diseases Headache Disorders Headache Disorders, Primary Intestinal Diseases Irritable Bowel Syndrome Migraine Disorders Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Occupational Diseases Persian Gulf Syndrome Rheumatic Diseases War-Related Injuries Wounds and Injuries

Age range

38 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Submaximal bicycle exercise stress tests performed 24 hr apart

Diagnostic Test

Submaximal bicycle exercise stress tests were performed for 25 min at 70% predicted heart rate, then ramped up to 85% predicted heart rate. Subjects could stop when they felt they had reached their maximum effort if before reaching 85% predicted heart rate.

Primary outcomes

To assess the alterations due to exercise in Gulf War Veterans

Time frame: 02/2009-09/2012

Difference in duration of exercise between first and second submaximal bicycle exercise stress test

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

U.S. Army Medical Research and Development Command

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Feb 8, 2011
Registry last updated: Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed