Effects of Therapeutic Exercise in Patients With Fibromyalgia

Study Overview
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Brief Summary
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Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients. The objective of this trial is to evaluate if therapeutic exercise is effective on fatigue, pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic markers. For this purpose, the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR). Patients included one group receiving exercise therapy consisting of 3 treatment sessions a week over 10 weeks. The variables are measured at the beginning and end of treatment.

Official Title
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Effects of Therapeutic Exercise in Patients With Fibromyalgia

Conditions
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Therapeutic Exercise, Chronic Pain

Intervention / Treatment
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* Other: Therapeutic Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed medically with Fibromyalgia Diagnosed according to the American College of Rheumatology criteria Agreement to attend to treatment sessions Exclusion Criteria: Any kind of contraindications for physical activity Other kind of diseases that could limit the intervention Previous surgery last year Medication modifications in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Therapy<br> | Other: Therapeutic Exercise<br>* Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | VAS | Baseline | 
| Pain intensity | VAS | through study completion, an average 10 weeks | 
| Quality of Sleep | The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline | Baseline | 
| Quality of Sleep | The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline | through study completion, an average 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold | The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at baseline | Baseline | 
| Pressure pain threshold | The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at the end of treatment | through study completion, an average 10 weeks | 
| Central sensitization | The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline | Baseline | 
| Central sensitization | The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) | through study completion, an average 10 weeks | 
| Analysis of tryptophan metabolites | The investigators measure the tryptophan metabolites with blood test analysis at baseline | Baseline | 
| Analysis of tryptophan metabolites | The investigators measure the tryptophan metabolites with blood test analysis at baseline | through study completion, an average 10 weeks |