Mat Pilates Method in the Treatment of Women With Fibromyalgia

Fibromyalgia, Primary Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149198
• Other study ID #: CAAE0000
• Status: Completed
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 1, 2018
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia, Primary
• Myofascial Pain Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Marcelo Souza	Santa Cruz	Rio Grande Do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Pain	Visual analogic scale (0-10)	baseline
Primary	Assessment of Pain	Visual analogic scale (0-10)	12 week
Secondary	Assessment of Function	Fibromyalgia Impact Questionnaire	baseline
Secondary	Assessment of Function	Fibromyalgia Impact Questionnaire	12 Week
Secondary	Assessment of Quality of life	SF-36 Questionnaire	baseline
Secondary	Assessment of Quality of life	SF-36 Questionnaire	12 week
Secondary	Assessment of Physical Function	Timed Up and Go test - This is a performance functional test	baseline
Secondary	Assessment of Physical Function	Timed Up and Go test- This is a performance functional test	12 week