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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01350492
First received: May 5, 2011
Last updated: June 27, 2016
Last verified: June 2016
  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:


Further study details as provided by VA Office of Research and Development:

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 2017
Estimated Primary Completion Date: August 2017 (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
No Intervention: Arm 2
Waitlist Control

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years   (Adult)
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 Veteran's pain
  • Use of exclusionary drugs 3 weeks prior to testing
  • Major depressive disorder with melancholic features
  • Substance abuse
  • Schizophrenia
  • Bipolar disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350492

Contacts
Contact: Dane B Cook, PhD (608) 256-1901 cooklab@education.wisc.edu

Locations
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI Recruiting
Madison, Wisconsin, United States, 53705
Contact: Aaron J Stegner, PhD    608-262-2457    cooklab@education.wisc.edu   
Principal Investigator: Dane B Cook, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Dane B Cook, PhD William S. Middleton Memorial Veterans Hospital, Madison, WI
  More Information

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01350492     History of Changes
Other Study ID Numbers: SPLD-004-10S 
Study First Received: May 5, 2011
Last Updated: June 27, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
pain
brain imaging
exercise

Additional relevant MeSH terms:
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2016