Mat Pilates Method in the Treatment of Women With Fibromyalgia

NCT03149198 | Completed DMC

• 1 other identifier: CAAE0000
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia, Primary

Keywords

Fibromyalgia, pilates, exercises

Outcome Measures

Primary Outcomes (2)

• Assessment of Pain

  Visual analogic scale (0-10)

  baseline

• Assessment of Pain

  Visual analogic scale (0-10)

  12 week

Secondary Outcomes (6)

• Assessment of Function

  baseline

• Assessment of Function

  12 Week

• Assessment of Quality of life

  baseline

• Assessment of Quality of life

  12 week

• Assessment of Physical Function

  baseline

Study Arms (2)

Interventional group

EXPERIMENTAL

Mat pilates exercises

Other: Mat Pilates exercises

Control group

ACTIVE COMPARATOR

Aquatic aerobic exercises

Other: Aquatic aerobic exercises

Interventions

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.

Interventional group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Marcelo Souza

Santa Cruz, Rio Grande do Norte, 59200-000, Brazil

Location

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 11, 2017
• Study Start: September 4, 2017
• Primary Completion: December 7, 2017
• Study Completion: August 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)