Mat Pilates Method in the Treatment of Women With Fibromyalgia

Study Overview
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Brief Summary
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Introduction: Physical exercises have been recommended to improve overall well-being in patients with fibromyalgia, with the main goal of repairing the effects of lack of physical conditioning, and improving symptoms especially pain and fatigue. Very well estimated and widely known are the studies that support the use of the pilates method as effective in improving the symptoms of the disease. Objective: To evaluate the effectiveness of the soil method in improving pain in women with fibromyalgia in the city of Santa Cruz, RN. Methodology: This is a randomized controlled trial with blind evaluator, where 60 patients with fibromyalgia diagnosis are divided into two groups. The intervention group, perform an exercise program based on the pilates method in soil and another, considered control group, participate in a program of aerobic exercises in the pool. Both groups conduct supervised exercise programs 2 times a week for a period of 12 weeks. The evaluation instruments used in an EVA (visual pain scale); FIQ Questionnaire - Fibromyalgia Impact Questionnaire; Functional ability by the Timed Up and Go test and 6-minute walk test; A quality of sleep by the Pittsburgh Sleep Quality Index (PSQI-BR) and an ESS-BR (Epworth Sleepiness Scale); Finally, a general quality of life for the SF-36. Statistical analysis: Data are analyzed by t-student, Mann-Whitney test, repeated-measures ANOVA and intention-to-treat analysis.

Official Title
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Assessment of the Effectiveness of the Mat Pilates Method in the Treatment of Women With Fibromyalgia in the Santa Cruz City, Rio Grande do Norte, Brazil: A Randomized Controlled Trial

Conditions
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Fibromyalgia, Primary

Intervention / Treatment
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* Other: Mat Pilates exercises
* Other: Aquatic aerobic exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients with fibromyalgia diagnosed according to the classification criteria of the American College of Rheumatology, aged 18 to 60 years, with VAS between 3 and 8, who signed the free and informed consent term. Exclusion Criteria: Patients with uncontrolled hypertension; Decompensated cardiorespiratory disease; History of syncopes or arrhythmias induced by physical exercise; Diabetes unbalanced; Psychiatric disorders; History of regular physical exercise (at least 2 times a week) in the last 6 months any other condition that makes it impossible for a patient to perform physical exercises.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>Mat pilates exercises | Other: Mat Pilates exercises<br>* The exercise program based on the pilates method will be performed on the ground in the group room of the FACISA / UFRN Physiotherapy School Clinic in Santa Cruz. The room has ample space and air conditioning for better patient accommodation. The exercises will be performed twice a week for 12 weeks. Each session will last about 50 minutes and will be supervised by a physical therapy student along with the research coordinator. A total of 10 exercises will be performed.<br>|
| Active Comparator: Control group<br>Aquatic aerobic exercises | Other: Aquatic aerobic exercises<br>* The aerobic exercise program will be held in the therapeutic pool of the Physiotherapy School Clinic of FACISA / UFRN in Santa Cruz. The pool is heated and provides better effects to the proposed treatment. The exercises will be performed twice a week for 12 weeks. Each session will last about 50 minutes and will be supervised by another physical therapy student along with the research coordinator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pain | Visual analogic scale (0-10) | baseline | 
| Assessment of Pain | Visual analogic scale (0-10) | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Function | Fibromyalgia Impact Questionnaire | baseline | 
| Assessment of Function | Fibromyalgia Impact Questionnaire | 12 Week | 
| Assessment of Quality of life | SF-36 Questionnaire | baseline | 
| Assessment of Quality of life | SF-36 Questionnaire | 12 week | 
| Assessment of Physical Function | Timed Up and Go test - This is a performance functional test | baseline | 
| Assessment of Physical Function | Timed Up and Go test- This is a performance functional test | 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, pilates, exercises