Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Protocol Based on Physical Exercise and Stretching

Study Overview
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Brief Summary
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This study evaluates the effect to a muscle stretching program combined with physical exercise versus a physical exercise program in patients with fibromyalgia.

Detailed Description
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Although classically this pathology was characterized by having an unknown etiology, current research suggests that the disease shows several abnormalities in the central pain processing. Central sensitization is defined as changes in neuroplasticity of central nervous system as a result of persistent and intense sensory information nociceptive generated by peripheral and transmitted to the neurons in the dorsal horn of the cord through the nerves of the peripheral nervous system tissues, through a constant activity of C fibers and A-beta fibers. In recent years the theory that pain is responsible for other symptoms, is changing, and it is theorized that the quality of sleep directly influences in the symptoms. The treatment of fibromyalgia is based on trying to reduce pain and associated symptoms described above in order to improve the quality of life of these patients. Almost all revisions studying the effects of physical activity in fibromyalgia agree that it is effective in reducing the overall impact on the disease and its symptoms. Muscle strength training aim to improve the strength, endurance and muscle power. There are few conclusive studies on the benefits of stretching and flexibility exercises on the impact of fibromyalgia.

Official Title
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Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Combined Protocol Based on Physical Exercise and Muscle Stretching

Conditions
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Fibromyalgia, Sleep, Stretch

Intervention / Treatment
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* Procedure: Muscle Stretching
* Procedure: Physical Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18 years or more. To be diagnosed with fibromyalgia according to the criteria established by the American College of Rheumatology, either on the basis of its publication of 1990 or the current revision of 2010. Accept to volunteer and give oral consent. Before starting the intervention must be provided written informed consent. Exclusion Criteria: Do not present any pathology in which physical exercise is contraindicated. Do not suffer another serious somatic illness or severe psychological disorder. Not suffer severe dementia (MMSE <10). Do not be participating at the time of the study in any other intervention of physical or psychological.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical Exercise<br>Aerobic physical exercise protocol of moderate intensity, for 12 weeks, 3 sessions per week, about 12 minutes. Physical activity chosen will be pedaling on a static bike. | Procedure: Physical Exercise<br>* Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.<br>|
| Experimental: Muscle Stretching<br>Stretching program on the main muscle groups of the body, for 12 weeks, 1sessions per week, about 45 minutes. | Procedure: Muscle Stretching<br>* Subjects completed one stretching session on the main muscle groups of the body weekly.<br>Procedure: Physical Exercise<br>* Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh sleep quality index | The Pittsburgh Sleep Quality Index, where a lower score (0-21), better sleep quality. Follows a continuous metric scale. | At the beginning, every two weeks up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth sleepiness scale | The Epworth Sleepiness Scale, where a lower score (0-24), better sleep. Follows a continuous metric scale. | At the beginning, every two weeks up to 12 weeks | 
| Sleep scale (medical outcomes study) | The Sleep Scale from the Medical Outcomes Study evaluates the quality of sleep with a score of (0-100), where 0 is no problem and 100 is maximum problems. Follows a continuous metric scale. | At the beginning, every two weeks up to 12 weeks | 
| Visual analog scale | The visual analog scale measures the perceived pain with a score ofh a (0-100), where a higher score means more pain. Follows a continuous metric scale. | At the beginning, every two weeks up to 12 weeks | 
| Fibromyalgia impact questionnaire | The Fibromyalgia Impact Questionnaire follows a continuous metric scale, (0-100), where a higher score means lower quality of life. | At the beginning, every two weeks up to 12 weeks |