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临床试验/NCT01291758
NCT01291758已完成不适用

Exercise in Gulf War Illness (GWI)

Georgetown University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
To assess the alterations due to exercise in Gulf War Veterans

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
38 Years 至 86 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

To assess the alterations due to exercise in Gulf War Veterans

时间窗: 02/2009-09/2012

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Baraniuk, MD

Professor of Medicine

Georgetown University

研究点 (1)

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