Exercise in Gulf War Illness (GWI)

August 2, 2019 updated by: James Baraniuk, MD, Georgetown University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 86 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All veterans who served in the Armed Forces between August 1990 and July 1991

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
02/2009-09/2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

U.S. Army Medical Research and Development Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (ESTIMATE)

February 8, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-229
  • USAMRMC PR# W81XWH-09-1-0526 (OTHER_GRANT: Department of Defense)
  • HRPO Log No. A-15547 (OTHER: Human Research Protection Office)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Contact James N. Baraniuk MD at baraniuj@geogetown.edu Each request will be reviewed by Dr. Baraniuk and may require approval from the Georgetown University IRB Committee before data can be shared.

Efforts are underway to deidentify data for public access.

IPD Sharing Time Frame

Data are available for collaborative research as in Plan Description.

IPD Sharing Access Criteria

Access depends on the request and need for IRB approval

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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