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NCT Number: NCT03149198

Mat Pilates Method in the Treatment of Women With Fibromyalgia

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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Key information

Conditions

Fibromyalgia, Primary Behavior Fibromyalgia Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marcelo Souza

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Assessment of Pain

    Time frame: baseline

    Visual analogic scale (0-10)

  2. Assessment of Pain

    Time frame: 12 week

    Visual analogic scale (0-10)

Secondary outcomes

  1. Assessment of Function

    Time frame: baseline

    Fibromyalgia Impact Questionnaire

  2. Assessment of Function

    Time frame: 12 Week

    Fibromyalgia Impact Questionnaire

  3. Assessment of Quality of life

    Time frame: baseline

    SF-36 Questionnaire

  4. Assessment of Quality of life

    Time frame: 12 week

    SF-36 Questionnaire

  5. Assessment of Physical Function

    Time frame: baseline

    Timed Up and Go test - This is a performance functional test

  6. Assessment of Physical Function

    Time frame: 12 week

    Timed Up and Go test- This is a performance functional test

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 11, 2017
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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