Clinical trial NCT03149198: Mat Pilates Method in the Treatment of Women With Fibromyalgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia, Primary
Keywords: Fibromyalgia, pilates, exercises
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Pain
timeFrame: baseline
measure: Assessment of Pain
timeFrame: 12 week
Secondary outcomes:
measure: Assessment of Function
timeFrame: baseline
measure: Assessment of Function
timeFrame: 12 Week
measure: Assessment of Quality of life
timeFrame: baseline
measure: Assessment of Quality of life
timeFrame: 12 week
measure: Assessment of Physical Function
timeFrame: baseline
measure: Assessment of Physical Function
timeFrame: 12 week
Other outcomes:
Locations:
city: Santa Cruz
country: Brazil
facility: Marcelo Souza
state: Rio Grande Do Norte
Study officials:
References:
citation: 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.
citation: 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.