Mat Pilates Method in the Treatment of Women With Fibromyalgia

NCT03149198 — Not applicable, Completed, 42 participants, Universidade Federal do Rio Grande do Norte

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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

Registry	NCT03149198
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	42 (Actual)
Sponsor	Universidade Federal do Rio Grande do Norte (Other)
Conditions	Fibromyalgia, Primary
Interventions	Mat Pilates exercises, Aquatic aerobic exercises (Other)
Dates	start 2017-09-04, primary completion 2017-12-07, completion 2018-08-01, first posted 2017-05-11, last updated 2018-08-17
Locations	1 site in Brazil

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Interventional group	Experimental	Other: Mat Pilates exercises	Mat pilates exercises
Control group	Active comparator	Other: Aquatic aerobic exercises	Aquatic aerobic exercises

Mat Pilates exercises (Other): 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.
Aquatic aerobic exercises (Other): 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.

+Outcome measures

Primary outcomes

Assessment of Pain [baseline]: Visual analogic scale (0-10)
Assessment of Pain [12 week]: Visual analogic scale (0-10)

Secondary outcomes

Assessment of Function [baseline]: Fibromyalgia Impact Questionnaire
Assessment of Function [12 Week]: Fibromyalgia Impact Questionnaire
Assessment of Quality of life [baseline]: SF-36 Questionnaire
Assessment of Quality of life [12 week]: SF-36 Questionnaire
Assessment of Physical Function [baseline]: Timed Up and Go test - This is a performance functional test
Assessment of Physical Function [12 week]: Timed Up and Go test- This is a performance functional test

+Eligibility

Sex: Female, ages: 18 Years to 60 Years

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.

+Locations (1)

Facility	City	Country	Status
Marcelo Souza	Santa Cruz, Rio Grande do Norte	Brazil

+Publications

Results publication: de Medeiros SA, de Almeida Silva HJ, do Nascimento RM, da Silva Maia JB, de Almeida Lins CA, de Souza MC. Mat Pilates is as effective as aquatic aerobic exercise in treating women with fibromyalgia: a clinical, randomized and blind trial. Adv Rheumatol. 2020 Apr 6;60(1):21. doi: 10.1186/s42358-020-0124-2. PMID 32252822
Results publication: Silva HJA, Lins CAA, Nobre TTX, de Sousa VPS, Caldas RTJ, de Souza MC. Mat Pilates and aquatic aerobic exercises for women with fibromyalgia: a protocol for a randomised controlled blind study. BMJ Open. 2019 Feb 19;9(2):e022306. doi: 10.1136/bmjopen-2018-022306. PMID 30782866

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