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Gulf War IllnessNCT01291758

Exercise in Gulf War Illness (GWI)

An observational study of Gulf War Illness and Persian Gulf Syndrome, run by Georgetown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 38 to 86 yearsHealthy volunteers can take part
Conditions the study is for
Gulf War Illness, Persian Gulf Syndrome
What is being tested?
Submaximal bicycle exercise stress tests performed 24 hr apart
How many people
50 participants
Where
1 siteUnited States
Study dates
Jul 2009to Sep 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 38 to 86 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

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).

Read the 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.

Being tested
Submaximal bicycle exercise stress tests performed 24 hr apart
Keywords
Persian Gulf War, Gulf War Syndrome, GWI, Gulf War Illness, Exercise, Chronic Fatigue, Fibromyalgia, Veterans, Irritable Bowel Syndrome, Migraine headaches, Neuropathy
Medical subject headings
Persian Gulf Syndrome, Motor Activity, Fibromyalgia, Irritable Bowel Syndrome, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Submaximal bicycle exercise stress tests performed 24 hr apartDiagnostic 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.

Study groups in NCT01291758
Study groupRoleWhat they receive
GWIVeterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
Receives: Diagnostic Test: Submaximal bicycle exercise stress tests performed 24 hr apart
HCHealthy veterans of the 1990-1991 Persian Gulf War
Receives: Diagnostic Test: Submaximal bicycle exercise stress tests performed 24 hr apart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the alterations due to exercise in Gulf War Veterans

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

    Measured: 02/2009-09/2012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2011 (estimated)
  2. Study startJul 2009
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01291758
Sponsor's protocol ID
2009-229
Other IDs
USAMRMC PR# W81XWH-09-1-0526, HRPO Log No. A-15547
Status last verified
Aug 2019
First submitted
7 Feb 2011
Last updated
6 Aug 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastanaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. doi: 10.1093/aje/155.11.1033.

    PubMed 12034582

  • Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22. doi: 10.1186/1471-2377-5-22.

    PubMed 16321154

  • Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Koppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7. doi: 10.2337/diabetes.54.8.2320.

    PubMed 16046297

  • Casado B, Zanone C, Annovazzi L, Iadarola P, Whalen G, Baraniuk JN. Urinary electrophoretic profiles from chronic fatigue syndrome and chronic fatigue syndrome/fibromyalgia patients: a pilot study for achieving their normalization. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Jan 5;814(1):43-51. doi: 10.1016/j.jchromb.2004.09.056.

    PubMed 15607706

  • Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8. doi: 10.1001/jama.280.11.981.

    PubMed 9749480

  • Rayhan RU, Zheng Y, Uddin E, Timbol C, Adewuyi O, Baraniuk JN. Administer and collect medical questionnaires with Google documents: a simple, safe, and free system. Appl Med Inform. 2013;33(3):12-21.

    PubMed 24415903

  • Rayhan RU, Ravindran MK, Baraniuk JN. Migraine in gulf war illness and chronic fatigue syndrome: prevalence, potential mechanisms, and evaluation. Front Physiol. 2013 Jul 24;4:181. doi: 10.3389/fphys.2013.00181. eCollection 2013.

    PubMed 23898301

  • Rayhan RU, Stevens BW, Raksit MP, Ripple JA, Timbol CR, Adewuyi O, VanMeter JW, Baraniuk JN. Exercise challenge in Gulf War Illness reveals two subgroups with altered brain structure and function. PLoS One. 2013 Jun 14;8(6):e63903. doi: 10.1371/journal.pone.0063903. Print 2013.

    PubMed 23798990

  • Rayhan RU, Stevens BW, Timbol CR, Adewuyi O, Walitt B, VanMeter JW, Baraniuk JN. Increased brain white matter axial diffusivity associated with fatigue, pain and hyperalgesia in Gulf War illness. PLoS One. 2013;8(3):e58493. doi: 10.1371/journal.pone.0058493. Epub 2013 Mar 20.

    PubMed 23526988

  • Narayan V, Shivapurkar N, Baraniuk JN. Informatics Inference of Exercise-Induced Modulation of Brain Pathways Based on Cerebrospinal Fluid Micro-RNAs in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Netw Syst Med. 2020 Nov 18;3(1):142-158. doi: 10.1089/nsm.2019.0009. eCollection 2020.

    PubMed 33274349

Questions about this trial

What is this clinical trial studying?

An observational study of Gulf War Illness and Persian Gulf Syndrome, run by Georgetown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the alterations due to exercise in Gulf War Veterans (time frame: 02/2009-09/2012). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01291758, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.

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