Official Title: “Maximizing Exercise Effectiveness in Fibromyalgia”

The purpose of this trial was to test the combined and independent effects of 6 months of exercise and Mestinon in people with fibromyalgia. Specifically, we wanted to determine if Mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms improved by the end of the trial.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment

Study Primary Completion Date: June 2008

Earlier, we demonstrated that people with fibromyalgia fail to make adequate growth hormone when they exercise intensively. We also demonstrated that a single dose of Mestinon helped people make normal levels of growth hormone when they exercised in our laboratory. We wanted to know if 6 months of exercise with concurrent Mestinon therapy would make growth hormone (and related markers) normal and improve fibromyalgia symptoms.

Intervention(s) in this Clinical Trial

• Behavioral: Exercise
• Drug: pyridostigmine
• Drug: Placibo
• Behavioral: Attention Control

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Experimental: 4

Primary Measures

• Levels of growth hormone post exercise
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Improvement of fibromyalgia symptoms
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• Have Fibromyalgia

Exclusion Criteria:

• Subjects will be excluded if they have a history of rheumatic disease or other disorder that may compromise ability to safely complete study protocol, be pregnant, nursing, or currently involved in unresolved litigation.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Nursing Research (NINR)

Overall Clinical Trial Officials and Contacts

Edit Serfozo, MPH Study Director Oregon Health and Science University  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00535587

Study ID Number: 5R01NR8150-04

ClinicalTrials.gov Identifier: NCT00535587

Health Authority: United States: Federal Government