Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT00573612
Eligibility Criteria:
Inclusion Criteria:
1. American College of Rheumatology (ACR) classification criteria for FMS(203)
2. Has been on stable doses of FMS medications (i.e., cyclobenzaprine, tramadol, gabapentin, pregabalin, venlafaxine, duloxetine, pramipexole, tricyclic anti-depressant, selective serotonin reuptake inhibitor) for at least 4 weeks and willing to limit the introduction of new medications for FMS symptoms
3. Age between 18-65 years old. Because the prevalence of sub-clinical coronary artery disease increases with older age, we are excluding those who are ≥ 66 years old
Exclusion Criteria:
1. FIQ-PI score \< 2
2. BPI-PS \<4
3. Known cardiovascular disease, including congestive heart failure; previous episodes of angina pectoris; previous myocardial infarction; or previous revascularization procedure
4. Moderate-severe chronic obstructive pulmonary disease, including asthma
5. Uncontrolled hypertension
6. Orthopedic or musculoskeletal conditions that would prohibit moderate-intensity exercise
7. Active suicidal ideation
8. Planned elective surgery during the study period
9. Ongoing unresolved disability claims
10. Other major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue disease)
11. Use of medications that may affect chronotropic response to exercise, i.e. beta-blocker or calcium channel blocker
12. Pregnancy
13. Schizophrenia or other psychosis
14. Exercising 3 days a week or more. The US Surgeon General considers a physically active person as somebody who does at least 3 times a week of moderate to vigorous level of exercise(204). Thus, we are excluding the already physically active individuals from the study. In the pilot study, only 4% (2 out of 50) of the potential participants were excluded due to being physically active.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00573612
Study Brief:
Protocol Section:
NCT00573612