Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Study of Heart Rate Variability in Patients With Fibromyalgia - Effects of Strengthening Exercises
Brief Summary: Abstract Objective: Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia (FM). Exercise is an effective treatment, with benefits potentially mediated through changes in autonomic modulation. Strengthening is one of the less studied exercises in FM, and the acute and chronic effects of strengthening on the autonomic system remain unknown. The objective of this study is to assess the effects of strengthening exercises (STRE) on autonomic modulation, pain perception and the quality of life (QOL) of FM patients. Methods: Sedentary women with FM (ACR 1990) will be randomly selected to STRE or flexibility (FLEX) exercises in a blind controlled trial. The intensity of STRE will be set at 45% of the estimated load of 1 Repetition Maximum (RM) in 12 different exercises. The primary outcomes will be pain measured using the Visual Analog Scale (VAS) and the Heart Rate Variability (HRV) analysis. Other outcomes will be assess: fitness measured by treadmill test, the sit and reach test (Wells and Dillon's Bench), handgrip dynamometry; and quality of life by the Fibromyalgia Impact Questionnaire (FIQ), the Beck and Idate Trait-State Inventory (IDATE), a short-form health survey (SF-36). Statistical analyses and ethical procedures: The visual analog scale (VAS) for pain will be the primary measure used to determine sample size. Statistical significance will be set at 5% and power of 80%. These led to at least 58 participants to be randomized. The main hypothesis is that strengthening exercise is a better treatment than flexibility exercise to improve pain, HRV and quality of life. In all measures tested we will consider the null hypothesis (H0) as being the point of equality between groups tested and H1 the point of difference. Bilateral tests were carried out adopting a 5% level of significance. The normality of the results will be tested using the Shapiro-Wilk test. Student's "t"-test for paired samples will be used to perform intra-group comparisons at different times, when the data were normally distributed, and the nonparametric equivalent of Student's t-test (Wilcoxon test) will be used when the data show an asymmetrical distribution. To compare the data between the STRE and FLEX groups, ANOVA for repeated measures will be used, followed by post-hoc Bonferroni's test.


Options:
A: Inclusion Criteria:

* classification of fibromyalgia based on the criteria of the American College of Rheumatology
* female gender
* aged between 18 and 65 years

Exclusion Criteria:

* not having altered treatment in previous three years
* having signed a term of informed consent
* patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded
B: Inclusion Criteria:

* Classification criteria for Fibromyalgia (ACR 1990)
* Sedentary subjects (without regular physical activity in the last 3 months)
* Women between 18 to 65 years old

Exclusion Criteria:

* Cardiovascular and/or respiratory diseases that might limit physical activity (COPD, Pulmonary Fibrosis, asthma moderate to severe, respiratory insufficiency);
* Organ dysfunction (renal, hepatic, coronary, pulmonary insufficiency);
* Arterial hypertension and diabetes mellitus;
* Uncontrolled thyroid disease;
* Autoimmune rheumatic diseases and/or non-autoimmune with symptoms that might limit the movement or physical effort;
* The use of beta blockers, calcium channel blockers and any other anti-hypertensive, anticonvulsants; non tricycles antidepressants; opioid analgesic including tramadol.
* cyclobenzaprine \>10 mg/day, and amtriptyline \> 25 mg/day;
* Performing or have performed exercise within the last 3 months;
* Inability to understand the questionnaires;
* Positive treadmill test for myocardial ischemia;
* Receipt of the social security benefits.
C: Inclusion Criteria:

* Women with Fibromyalgia, interested in exercise twice a week

Exclusion Criteria:

* Other severe diseases
D: Inclusion Criteria:

* Subjects included adults over 40 years of age or older who met 1990 ACR criteria for the classification of FM. Those criteria include pain in three or more body quadrants (above the waist, below the waist, left of midline and right of midline) including axial pain by self-report for a minimum of three consecutive months.
* Additionally at least 11 of 18 muscle/tendon junction tender points were found to be painful via digital palpation of 4kg over 4 seconds by a trained examiner (Wolfe 1990).

Exclusion Criteria:

* Individuals were excluded if they practiced Tai chi within the past 6 months; - were exercising more than 30 minutes, three times weekly for past 3 months;
* could not independently ambulate without assistive devices;
* were unable to attain MD clearance for exercise within past 3 months;
* were unwilling to undergo random assignment; had cognitive impairment based on score \>3 Pfeiffer Mental Status;
* had significant depressive symptoms based on a score of \>27 on Beck Depression Inventory;
* had BPI pain severity scores less than 3/10, had planned elective surgery during the study period;
* were unwilling to keep all treatments/medications steady throughout the study period;
* were currently enrolled in another study.

Answer: B