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Mat Pilates Method in the Treatment of Women With Fibromyalgia

Primary Purpose

Fibromyalgia, Primary

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mat Pilates exercises
Aquatic aerobic exercises
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia, Primary focused on measuring Fibromyalgia, pilates, exercises

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Marcelo Souza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional group

Control group

Arm Description

Mat pilates exercises

Aquatic aerobic exercises

Outcomes

Primary Outcome Measures

Assessment of Pain
Visual analogic scale (0-10)
Assessment of Pain
Visual analogic scale (0-10)

Secondary Outcome Measures

Assessment of Function
Fibromyalgia Impact Questionnaire
Assessment of Function
Fibromyalgia Impact Questionnaire
Assessment of Quality of life
SF-36 Questionnaire
Assessment of Quality of life
SF-36 Questionnaire
Assessment of Physical Function
Timed Up and Go test - This is a performance functional test
Assessment of Physical Function
Timed Up and Go test- This is a performance functional test

Full Information

First Posted
April 20, 2017
Last Updated
August 15, 2018
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03149198
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Primary
Keywords
Fibromyalgia, pilates, exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Mat pilates exercises
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Aquatic aerobic exercises
Intervention Type
Other
Intervention Name(s)
Mat Pilates exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aquatic aerobic exercises
Intervention Description
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 Outcome Measure Information:
Title
Assessment of Pain
Description
Visual analogic scale (0-10)
Time Frame
baseline
Title
Assessment of Pain
Description
Visual analogic scale (0-10)
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Assessment of Function
Description
Fibromyalgia Impact Questionnaire
Time Frame
baseline
Title
Assessment of Function
Description
Fibromyalgia Impact Questionnaire
Time Frame
12 Week
Title
Assessment of Quality of life
Description
SF-36 Questionnaire
Time Frame
baseline
Title
Assessment of Quality of life
Description
SF-36 Questionnaire
Time Frame
12 week
Title
Assessment of Physical Function
Description
Timed Up and Go test - This is a performance functional test
Time Frame
baseline
Title
Assessment of Physical Function
Description
Timed Up and Go test- This is a performance functional test
Time Frame
12 week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Marcelo Souza
City
Santa Cruz
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59200-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make individual participant data (IPD) available to other researchers.
Citations:
PubMed Identifier
32252822
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.
Results Reference
derived
PubMed Identifier
30782866
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.
Results Reference
derived

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Mat Pilates Method in the Treatment of Women With Fibromyalgia

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