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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR008150 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral |
| ||
| pyridostigmine |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of Growth Hormone Post Exercise | Serum growth hormone at peak V02/treadmill | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Fibromyalgia Symptoms | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edit Serfozo, MPH | Oregon Health and Science University | Study Director |
| Kim Dupree Jones, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mestinon & Exercise | |
| FG001 | Mestinon and Attention Control | |
| FG002 | Placebo Pill and Exercise | |
| FG003 | Placebo Pill and Attention Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mestinon & Exercise | |
| BG001 | Mestinon and Attention Control | |
| BG002 | Placebo Pill and Exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Levels of Growth Hormone Post Exercise | Serum growth hormone at peak V02/treadmill | ITT | Posted | Mean | Standard Deviation | ng/ml | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mestinon & Exercise |
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6 discontinued due to medical reasons unrelated to the study 4 were unwilling to complete
1 relocated
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Dupree Jones | Oregon Health & Science University | 503 494 3837 | joneskim@ohsu.edu |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D011729 | Pyridostigmine Bromide |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
|
| Placibo | Drug |
|
| Attention Control | Behavioral |
|
| BG003 | Placebo Pill and Attention Control |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Improvement of Fibromyalgia Symptoms | Not Posted | 6 months |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Mestinon and Attention Control | 0 | 36 | 0 | 42 |
| EG002 | Placebo Pill and Exercise | 0 | 39 | 0 | 39 |
| EG003 | Placebo Pill and Attention Control | 0 | 41 | 0 | 41 |
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| D009422 |
| Nervous System Diseases |
| D001519 | Behavior |
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |