Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01291758
Other study ID # 2009-229
Secondary ID USAMRMC PR# W81X
Status Completed
Phase
First received
Last updated
Start date July 2009
Est. completion date September 2012

Study information

Verified date August 2019
Source Georgetown University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 38 Years to 86 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Georgetown University Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Georgetown University U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastañaga 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. Erratum in: Am J Epidemiol. 2005 Feb 1;161(3):302. — View Citation

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, Köppel 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. — View Citation

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. — View Citation

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.po — View Citation

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.00584 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 02/2009-09/2012
See also
  Status Clinical Trial Phase
Recruiting NCT04254627 - TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset Phase 1
Terminated NCT02011542 - Probiotic (VSL #3) for Gulf War Illness Phase 2/Phase 3
Recruiting NCT03078530 - Probiotic (Visbiome) for Gulf War Illness Phase 2/Phase 3
Recruiting NCT04058275 - "Immunomodulation in GWI (Phlebotomy)"
Recruiting NCT04255498 - Understanding GWI: Integrative Modeling Phase 1
Completed NCT02782780 - Cognitive Behavioral Therapy for Insomnia for Gulf War Illness N/A
Recruiting NCT02983734 - D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS) Phase 2
Recruiting NCT05972291 - Mechanisms of Gulf War Illness N/A
Recruiting NCT04182659 - Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms N/A
Recruiting NCT04046536 - rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI) N/A
Recruiting NCT05377242 - Curcumin, Resveratrol, and Stinging Nettle as Treatments for GWI N/A
Recruiting NCT05675878 - Confirmation of Diet as a Treatment for Gulf War Illness Phase 3
Recruiting NCT05736146 - Validating Gulf War Illness Blood Biomarkers
Not yet recruiting NCT05820893 - Resistant Potato Starch to Alleviate GWI Phase 2
Terminated NCT01846182 - Research Examining Gulf War Illness in Our Nations Service Members Phase 2
Active, not recruiting NCT05252949 - OEA for Targeting Lipid Metabolism in GWI N/A
Completed NCT02378025 - Treating Chronic Pain in Gulf War Illness N/A
Completed NCT02865460 - Coenzyme Q10 Phase III Trial in Gulf War Illness Phase 3
Completed NCT02909686 - Effects of Botanical Microglia Modulators in Gulf War Illness N/A
Completed NCT01011348 - Q10 for Gulf War Veterans N/A

External Links