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Trial record 1 of 7 for:    exercise | Interventional Studies | Gulf War | United States
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Impact of Exericse Training on Pain and Brain Function in Gulf War Veteans

This study is currently recruiting participants.
Verified July 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT01350492
First Posted: May 9, 2011
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Chronic Musculoskeletal Pain Behavioral: Resistance Exercise Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
    Symptoms are quantified with a review of participants' CPRS records and the repeated administration of self-report questionnaire batteries.


Secondary Outcome Measures:
  • Physical Activity [ Time Frame: Baseline, during 16 weeks of exercise and 6 and 12 months post exercise ]
    Physical activity is measured via accelerometer and self-report questionnaires.

  • Brain Structure and Function [ Time Frame: Baseline, during 16 weeks of exercise and 6 and 12 months post exercise ]
    Brain structure and function data are gathered using a 3-Tesla MRI scanner over the course of six sessions.


Estimated Enrollment: 68
Actual Study Start Date: April 16, 2013
Estimated Study Completion Date: December 30, 2017
Estimated Primary Completion Date: August 29, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 5, 2011
First Posted: May 9, 2011
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: 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