Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia

Study Overview
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Brief Summary
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Physical activity has been used for a number of years in the treatment of fibromyalgia (FM). The main objective of this study is to compare the effects of physical activity on two groups of women diagnosed with fibromyalgia (FM) in terms of pain, quality of life and the impact of the condition on their daily lives. Methods: this was a randomized clinical trial to assess the effects of physical activity performed by subjects assigned to one of two groups on the scores of three questionnaires (the pain Visual Analogue Scale, the FIQ questionnaire and the SF-36 health questionnaire) administered before and after the intervention.

Official Title
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Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women Ages of 40 and 75 Diagnosis fibromyalgia (code M79.7) Anoia region Exclusion Criteria: Pregnant Unable to participate in the physical activity program.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, multi-center, clinical trial composed of two groups response variables and a twelve weeks follow up.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physical activity group<br> | Other: Physical activity<br>* The intervention group: engaged in a therapeutic physical activity program involving low-intensity exercise, strength and balance work for 2 days a week over a 12-week period, with each session lasting 90 minutes. Both the intervention group and the control group separately completed the various baseline surveys which were part of the study. Once the intervention was over, they answered them again, also separately. The classes were led by an experienced physiotherapist who followed the physical exercise guidelines established by the American College of Sports Medicine (ACSM), although the intensity of the exercises was adapted to the participants' tolerance levels<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The visual analogue scale (VAS) | evaluate pain, with a score of 0 to 10 | two months | 
| The Spanish version of the SF-36 questionnaire | used to assess their perceived state of health. It includes eight variables: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health | two months | 
| the Fibromyalgia Impact Questionnaire (FIQ) | measures physical functioning, ability to undertake work and general well-being, with a score from 0 to 80. | two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, fibromyalgia, pain, exercice, quality of live