Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 37 for:    mat pilates

Mat Pilates Method in the Treatment of Women With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149198
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Marcelo Cardoso de Souza, Universidade Federal do Rio Grande do Norte

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia, Primary Other: Mat Pilates exercises Other: Aquatic aerobic exercises Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 4, 2017
Actual Primary Completion Date : December 7, 2017
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149198


Locations
Layout table for location information
Brazil
Marcelo Souza
Santa Cruz, Rio Grande Do Norte, Brazil, 59200-000
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marcelo Cardoso de Souza, Prof. Dr., Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT03149198    
Other Study ID Numbers: CAAE0000
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data (IPD) available to other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcelo Cardoso de Souza, Universidade Federal do Rio Grande do Norte:
Fibromyalgia, pilates, exercises
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases