Fibromyalgia Clinical Trial
Official title:
The Study of Heart Rate Variability in Patients With Fibromyalgia - Effects of Strengthening Exercises
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Valéria Valim | Vitória | Espírito Santo |
Lead Sponsor | Collaborator |
---|---|
Federal University of Espirito Santo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain | Visual analogic scale | 4 weeks | No |
Secondary | Fibromyalgia Impact Questionnaire | Symptoms | Initial, 8 weeks, 16 weeks | No |
Secondary | Short Form Health Survey | Initial, 8 weeks, 16 weeks | No | |
Secondary | State-Trait Anxiety Inventory (IDATE) | Mood evaluation | initial, 8 weeks, 16 weeks | No |
Secondary | BECK Depression Inventory | Mood evaluation | Initial, 8 weeks, 16 weeks | No |
Secondary | Treadmill test | cardiorespiratory fitness cardiovascular risk | initial and 16 weeks | Yes |
Secondary | Sit and Reach Test | flexibility | 4 weeks | No |
Secondary | dynamometry | global strength | 4 weeks | No |
Secondary | Maximal repetition test | muscle strength | 4 weeks | No |
Secondary | autonomic modulation | Ratio low frequecy to high frequency in the Heart rate variability | 4 weeks | No |
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