Mat Pilates Method in the Treatment of Women With Fibromyalgia

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia, Primary
• Intervention / Treatment: Other: Mat Pilates exercises; Other: Aquatic aerobic exercises

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Norte
    • Santa Cruz, Rio Grande Do Norte, Brazil, 59200-000
      • Marcelo Souza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional group; Mat pilates exercises	Other: Mat Pilates exercises; 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.
ACTIVE_COMPARATOR: Control group; Aquatic aerobic exercises	Other: Aquatic aerobic exercises; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2017
• Primary Completion (ACTUAL): December 7, 2017
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (ACTUAL): May 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Fibromyalgia, pilates, exercises
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: CAAE0000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No