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Testing Mestinon and Exercise in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00535587
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : April 18, 2011
Last Update Posted : April 18, 2011
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
Oregon Health and Science University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Exercise Drug: pyridostigmine Drug: Placibo Behavioral: Attention Control Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Maximizing Exercise Effectiveness in Fibromyalgia
Study Start Date : September 2002
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Behavioral: Exercise
Drug: pyridostigmine
Other Name: Mestinon
Experimental: 2 Drug: pyridostigmine
Other Name: Mestinon

Drug: Placibo
Experimental: 3 Behavioral: Exercise
Behavioral: Attention Control
Experimental: 4 Drug: Placibo
Behavioral: Attention Control


Outcome Measures
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Primary Outcome Measures :
  1. Levels of Growth Hormone Post Exercise [ Time Frame: 6 months ]
    Serum growth hormone at peak V02/treadmill


Secondary Outcome Measures :
  1. Improvement of Fibromyalgia Symptoms [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT00535587


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97219
Sponsors and Collaborators
Oregon Health and Science University
National Institute of Nursing Research (NINR)
Investigators
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Study Director: Edit Serfozo, MPH Oregon Health and Science University
Principal Investigator: Kim Dupree Jones, PhD Oregon Health and Science University
More Information
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Responsible Party: Kim Dupree Jones PhD, Associate Professor, Oregon Health & Science University, School of Nursing
ClinicalTrials.gov Identifier: NCT00535587    
Other Study ID Numbers: 5R01NR008150-04 ( U.S. NIH Grant/Contract )
R01NR008150 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2007    Key Record Dates
Results First Posted: April 18, 2011
Last Update Posted: April 18, 2011
Last Verified: March 2011
Keywords provided by Oregon Health and Science University:
Fibromyalgia
Exercise
Mestinon
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
 Pyridostigmine Bromide
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs