Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exercise-based Motivational Interviewing for Fibromyalgia
Brief Summary: Fibromyalgia (FMS), defined as the presence of both chronic widespread pain and the finding of 11/18 tender points on examination, affects 2% of the general population. Drug therapy for FMS is largely symptomatic as there is not yet a complete understanding of the pathogenesis of the disease. In the past 17 years, supervised aerobic exercise has emerged as an important treatment modality to improve pain, aerobic capacity, function, and well-being. Individuals who are able to adhere to exercise almost always maintain the symptomatic benefits of exercise. Unfortunately, the rate of exercise adherence six months after the completion of a well-structured supervised exercise program is disappointingly low. Furthermore, although the efficacy of supervised aerobic exercise in the research setting is well documented, the applicability of such intervention in the clinic setting is doubtful. Therefore, we propose to conduct the Research to Encourage Exercise for Fibromyalgia (REEF), a randomized attention-controlled trial whose primary aim is to evaluate the efficacy of telephone-delivered motivational interviewing (MI) to encourage exercise, in improving exercise adherence and self-report physical function (co-primary outcome measures) for FMS patients. REEF will enroll 200 FMS patients, randomizing them to either the MI group or the attention-control (AC) group. Participants from each group will receive a total of 6 telephone calls within a 12-week period. Prior to the phone calls, participants from both groups will receive an individualized exercise prescription and 2 supervised exercise training sessions to get them started on an exercise program. All subjects will undergo comprehensive outcome assessment at baseline, week 12, week 24, and week 36. The secondary aim of this proposal is to determine the mediators between MI and improvement in self-report physical function. The proposed research is significant because our focus is the promotion of adherence to an exercise program, of adequate intensity, in order to maximize functioning and well-being for patients with FMS. The use of a predominantly home-based exercise program and telephone-delivered MI by a trained licensed practice nurse (LPN) could potentially make the proposed intervention more accessible to the greater majority of FMS patients. Furthermore, if proven efficacious, MI could readily be applied to other chronically painful conditions (e.g. chronic back pain).


Options:
A: 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.
B: Inclusion Criteria:

* Women aged 25 to 75 years of age
* A confirmed diagnosis of FMS by a primary care physician (and rheumatologist if present) using the American College of Rheumatology criteria
* Currently under care for their FMS by a primary care physician or rheumatologist
* Determined to be medically stable by their primary care physician and capable of participation in a supervised program of low to moderate intensity exercise
* Willingness to commit to time and travel requirements of project

Exclusion Criteria:

* Do not fulfill ACR definition of FMS
* Presence of a concurrent condition that limits a person's ability to perform the exercise program (i.e., advanced RA or OA, recent MI)
* History of a positive exercise/stress test, or current cardiovascular, pulmonary, neurological, or renal disease where an exercise program is contraindicated
* Uncontrolled hypertension, diabetes, asthma, or heart failure
* Physician does not want his/her patient to participate for any reason
C: Inclusion Criteria: ACR 1990 criteria for fibromyalgia -

Exclusion Criteria: Other dominating pain condition, severe disease preventing from participating in physical exercise

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D: Inclusion Criteria:

* Criteria diagnosis according ACR 1990
* Wash-out of medication specific for fibromyalgia for 1 month
* Only paracetamol 750mg will be allowed during the period of study.

Exclusion Criteria:

* Alterations that against indicate the practical one of physical activity evaluated previously in clinical and rheumatology evaluation

Answer: A