Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2009-07-31
2012-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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GWI
Veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
38 Years
86 Years
ALL
Yes
Sponsors
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U.S. Army Medical Research and Development Command
FED
Georgetown University
OTHER
Responsible Party
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James Baraniuk, MD
Professor of Medicine
Principal Investigators
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James N Baraniuk, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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Georgetown University
Washington D.C., District of Columbia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Laboratory Website
Other Identifiers
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USAMRMC PR# W81XWH-09-1-0526
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HRPO Log No. A-15547
Identifier Type: OTHER
Identifier Source: secondary_id
2009-229
Identifier Type: -
Identifier Source: org_study_id
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