Mat Pilates Method in the Treatment of Women With Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT03149198|
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : August 17, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Assessment of Pain [ Time Frame: baseline ]Visual analogic scale (0-10)
- Assessment of Pain [ Time Frame: 12 week ]Visual analogic scale (0-10)
- Assessment of Function [ Time Frame: baseline ]Fibromyalgia Impact Questionnaire
- Assessment of Function [ Time Frame: 12 Week ]Fibromyalgia Impact Questionnaire
- Assessment of Quality of life [ Time Frame: baseline ]SF-36 Questionnaire
- Assessment of Quality of life [ Time Frame: 12 week ]SF-36 Questionnaire
- Assessment of Physical Function [ Time Frame: baseline ]Timed Up and Go test - This is a performance functional test
- Assessment of Physical Function [ Time Frame: 12 week ]Timed Up and Go test- This is a performance functional test
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
|Santa Cruz, Rio Grande Do Norte, Brazil, 59200-000|