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.
Description
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.
Status: Completed (Phase 2). Started on September 1st, 2002.
Enrollment: 178 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double Blind (Subject
- Investigator)
- Primary Purpose: Treatment
Conditions:
Interventions:
- Behavioral: Exercise
- Drug: pyridostigmine (Mestinon)
- Drug: Placibo
- Behavioral: Attention Control
Eligibility
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
Both
- Mininum Age
21 Years
- Maximum Age
65 Years
- Healthy Volunteers
No
Resources
Source: Oregon Health and Science University
Authority: United States: Federal Government
Locations
-
Oregon Health & Science University
Portland
Oregon
97219
United States
Officials
Edit Serfozo, MPH (Study Director, Oregon Health and Science University)
Kim Dupree Jones, PhD (Principal Investigator, Oregon Health and Science University)
Sponsors
Oregon Health and Science University (Lead Sponsor)
National Institute of Nursing Research (NINR) (Collaborator)
References
None.
Links
None.
- Date Verified
- March 1st, 2011
- First Received
- March 23rd, 2011
- Last Changed
- March 23rd, 2011
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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