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Impact of Exercise Training on Pain and Brain Function in Gulf War Veterans

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01350492
First received: May 5, 2011
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

This study is intended to test the influence of weight training on physical symptoms, physical activity and brain structure and function in Gulf War Veterans with chronic widespread muscle pain.


Condition Intervention Phase
Chronic Musculoskeletal Pain
 Behavioral: Resistance Exercise Training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Exercise Training on Pain and Brain Function in Gulf War Veterans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Symptoms [ Time Frame: Baseline, during 16 weeks of exercise and 6 and 12 months post exercise ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical Activity [ Time Frame: Baseline, during 16 weeks of exercise and 6 and 12 months post exercise ] [ Designated as safety issue: No ]
  • Brain Structure and Function [ Time Frame: Baseline, during 16 weeks of exercise and 6 and 12 months post exercise ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: April 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Resistance exercise training
 Behavioral: Resistance Exercise Training
16 weeks of resistance exercise training for the treatment of chronic muscle pain compared to wait-list control

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veteran of the Persian Gulf War
  • Chronic muscle pain

Exclusion Criteria:

  • Regular participation in resistance exercise
  • Color blindness
  • Claustrophobia
  • Medical conditions that could explain the veterans pain
  • Use of exclusionary drugs 3 weeks prior to testing
  • Major depressive disorder
  • Substance abuse
  • Schizophrenia
  • Bipolar disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350492

Locations
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Dane B. Cook, PhD William S. Middleton Memorial Veterans Hospital, Madison, WI
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01350492     History of Changes
Other Study ID Numbers: SPLD-004-10S
Study First Received: May 5, 2011
Last Updated: April 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
pain
brain imaging
exercise

ClinicalTrials.gov processed this record on May 21, 2013