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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01350492 |
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Date of registration:
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05/05/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of Exercise Training on Pain and Brain Function in Gulf War Veterans
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Scientific title:
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Impact of Exercise Training on Pain and Brain Function in Gulf War Veterans |
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Date of first enrolment:
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April 16, 2013 |
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Target sample size:
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77 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01350492 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Dane B. Cook, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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William S. Middleton Memorial Veterans Hospital, Madison, WI |
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Key inclusion & exclusion criteria
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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
Age minimum:
35 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Musculoskeletal Pain
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Intervention(s)
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Behavioral: Resistance Exercise Training
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Primary Outcome(s)
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Patients' Global Impression of Change (PGIC).
[Time Frame: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.]
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Physical Component Score (PCS) From the Veterans Rand 36 Item Heath Survey (VR-36).
[Time Frame: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.]
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Short Form McGill Pain Questionnaire Visual Analog Scale (VAS).
[Time Frame: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.]
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Secondary Outcome(s)
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Brain Structure: White Matter Tract Integrity, Operationalized With Fractional Anisotropy (FA) Measures at the Body of the Corpus Callosum.
[Time Frame: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months]
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Physical Activity (Self-report)
[Time Frame: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.]
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Physical Activity (Accelerometer)
[Time Frame: 6 weeks, 11 weeks, 17 weeks and 6 and 12 months post intervention.]
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Secondary ID(s)
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SPLD-004-10S
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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