Fibromyalgia
Conditions
Keywords
Fibromyalgia, Exercise, Mestinon
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.
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.
Interventions
Sponsors
National Institute of Nursing Research (NINR)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Growth Hormone Post Exercise | 6 months | Serum growth hormone at peak V02/treadmill |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of Fibromyalgia Symptoms | 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mestinon & Exercise | 53 |
| Mestinon and Attention Control | 53 |
| Placebo Pill and Exercise | 47 |
| Placebo Pill and Attention Control | 54 |
| Total | 207 |
Baseline characteristics
| Characteristic | Mestinon and Attention Control | Placebo Pill and Exercise | Mestinon & Exercise | Placebo Pill and Attention Control | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 47 Participants | 53 Participants | 54 Participants | 207 Participants |
| Age Continuous | 49 years STANDARD_DEVIATION 8 | 50 years STANDARD_DEVIATION 7 | 49 years STANDARD_DEVIATION 9 | 49 years STANDARD_DEVIATION 8 | 49 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 53 participants | 47 participants | 53 participants | 54 participants | 207 participants |
| Sex: Female, Male Female | 49 Participants | 45 Participants | 53 Participants | 54 Participants | 201 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 42 | 0 / 39 | 0 / 41 |
| serious Total, serious adverse events | 0 / 43 | 0 / 36 | 0 / 39 | 0 / 41 |
Outcome results
Primary
Levels of Growth Hormone Post Exercise
Serum growth hormone at peak V02/treadmill
Time frame: 6 months
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mestinon/Exercise | Levels of Growth Hormone Post Exercise | 4.95 ng/ml | Standard Deviation 3.07 |
| Placebo Pill/Attention Control | Levels of Growth Hormone Post Exercise | 1.41 ng/ml | Standard Deviation 2.94 |
p-value: <0.02ANCOVA
Secondary
Improvement of Fibromyalgia Symptoms
Time frame: 6 months