Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome.

Detailed Description
-----------------
The limited literature published in concordant relation affects the chronic fatigue syndrome comorbidity in the daily life of fibromyalgia patients leads us to design this study with the main objective of evaluating differences in the quality of life associated with pain and stress, mainly in relation to levels of physical activity, sedentary lifestyle and sleep in patients diagnosed with fibromyalgia, with or without a parallel co-diagnosis of chronic fatigue syndrome.

Official Title
-----------------
Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia on Physical Activity, Quality of Life and Immunoneuroendocrine Response.

Conditions
-----------------
Fibromyalgia, Chronic Fatigue Syndrome, Comorbidities and Coexisting Conditions

Intervention / Treatment
-----------------
* Behavioral: Subjective quality of live
* Procedure: Blood extraction
* Behavioral: Accelerometry
* Dietary Supplement: Synbiotic complement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fibromyalgia and/or Chronic Fatigue Syndrome diagnosis by rheumatologists or internal medicine professionals. Age not less than 40 years old and not more than 65 years old. Exclusion Criteria: Suffering from diagnosed major depression. Suffer diagnosed multiple chemical sensitivity. Corticosteroid treatment or anti-cytokine therapies. Periodically carry out programmed therapeutic physical activity in the two months prior to the accelerometry tests.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Healthy Women<br>Aged-matched control group of healthy women. | Behavioral: Subjective quality of live<br>* The groups fill out scientifically validated questionnaires to know the differences in perceived stress, anxiety, quality of life, depression, quality of sleep, pain, fatigue, and impact of the disease on daily life.<br>Procedure: Blood extraction<br>* Blood collection by qualified personnel.<br>Behavioral: Accelerometry<br>* To know the objective differences between physical activity/sedentary lifestyle, caloric expenditure and quality of sleep, we used the accelerometry technique<br>|
| Only Fibromyalgia<br>Patients diagnosed only with fibromyalgia. | Behavioral: Subjective quality of live<br>* The groups fill out scientifically validated questionnaires to know the differences in perceived stress, anxiety, quality of life, depression, quality of sleep, pain, fatigue, and impact of the disease on daily life.<br>Procedure: Blood extraction<br>* Blood collection by qualified personnel.<br>Behavioral: Accelerometry<br>* To know the objective differences between physical activity/sedentary lifestyle, caloric expenditure and quality of sleep, we used the accelerometry technique<br>Dietary Supplement: Synbiotic complement<br>* On two separate days, the baseline-tests and final-tests were conducted. All participants performed a series of tests, before which they had to fast. The order and schedule (8 am) of the tests was the same for the final-test and the same materials and procedures were used. A period of 30 consecutive days elapsed between the base-line and final tests, during which the participants had to ingest their supplement (synbiotic).<br>|
| Fibromyalgia and Chronic Fatigue Syndrome<br>Patients diagnosed with fibromyalgia and chronic fatigue syndrome. | Behavioral: Subjective quality of live<br>* The groups fill out scientifically validated questionnaires to know the differences in perceived stress, anxiety, quality of life, depression, quality of sleep, pain, fatigue, and impact of the disease on daily life.<br>Procedure: Blood extraction<br>* Blood collection by qualified personnel.<br>Behavioral: Accelerometry<br>* To know the objective differences between physical activity/sedentary lifestyle, caloric expenditure and quality of sleep, we used the accelerometry technique<br>Dietary Supplement: Synbiotic complement<br>* On two separate days, the baseline-tests and final-tests were conducted. All participants performed a series of tests, before which they had to fast. The order and schedule (8 am) of the tests was the same for the final-test and the same materials and procedures were used. A period of 30 consecutive days elapsed between the base-line and final tests, during which the participants had to ingest their supplement (synbiotic).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in perceived anxiety using the State-Trait Anxiety Inventory (STAI) | State-Trait Anxiety Inventory (STAI) is a self-reported, scientifically validated questionnaire that measures perceived anxiety. The STAI has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: I am tense; I am worried and I feel calm; I feel secure. Trait anxiety items include: I worry too much over something that really doesn't matter and I am content; I am a steady person. All items are rated on a 4-point scale (e.g., from Almost Never to Almost Always). Higher scores indicate greater anxiety. | During the intervention, at day 1. | 
| Differences in perceived stress using The Perceived Stress Scale (PSS) | The Perceived Stress Scale (PSS) is a self-reported, scientifically validated questionnaire that measures perceived stress. This scale is a self- report instrument that evaluates the level of perceived stress during the last month, and consists of 14 items with a 5-point response scale (0 = never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10, and 13 (in the following manner: 0 = 4, 1 = 3, 2 = 2, 3 = 1, and 4 = 0) and subsequently adding the 14 item scores. A higher score indicates a higher level of perceived stress. | During the intervention, at day 1. | 
| Differences in perceived depression using the Beck's Depression Inventory (BDI) | Beck's Depression Inventory (BDI) is a self-reported, scientifically validated questionnaire that measures perceived depression. Each of the 21 items on the BDI measures the presence and severity of a symptom of depression by requiring a self-rating from 0 to 3. Mild (low) scores are less than 4; moderate (medium) is between 14 and 20, and severe 21 and above. Unless otherwise indicated, the use of mild, moderate, and severe levels of depression throughout the remainder of this chapter will refer to the aforementioned ranges. | During the intervention, at day 1. | 
| Differences in perceived pain using the Brief Pain Inventory (BPI) | Brief Pain Inventory (BPI) is a self-reported, scientifically validated questionnaire that measures perceived pain. The BPI starts with a screening question, asking about the presence of pain and a body chart is used to indicate painful regions as well as the worst region. These items aren´t evaluated. This is followed by the core BPI items: the rating scales for pain severity and interference. Numerical rating scales from 0 to 10 are used for all items. The anchors for pain severity scales are 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whilst the interference anchors are 0 = 'no interference' and 10 = 'interferes completely'. | During the intervention, at day 1. | 
| Differences in perceived pain using the Brief Fatigue Inventory (BFI) | The Brief Fatigue Inventory (BFI) has nine items, with the items measured on 0-10 numeric rating scales. Three items ask patients to rate the severity of their fatigue at its worst, usual, andnow during normal waking hours, with 0 being no fatigue and 10 being fatigue as bad as you can imagine. Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The interference items are measured on a 0 -10 scale, with 0 beings does not interfere and 10 being completely interferes. | During the intervention, at day 1. | 
| Differences in subjective quality of sleep using The Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality lndex (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points. In all cases, a score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The seven component scores are then added to yield one global score, with a range of 0-21 points, 0 indicating no difficulty and 21  indicating severe difficulties in all areas. | During the intervention, at day 1. | 
| Differences in subjective quality of life using The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ) | The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ) This is a 26-item tool in which the respondent is asked to indicate the frequency of adopting 26 positively stated lifestyle habits using a Likert-type scale (1=Never or rarely, 2=Sometimes, 3=Often, and 4 = Always). | During the intervention, at day 1. | 
| Differences in perceived anxiety related to Coronavirus Disease (COVID-19) using the Coronavirus Anxiety Scale (CAS) | The Coronavirus Anxiety Scale is a brief mental health screener that can be used to identify cases of dysfunctional anxiety related to COVID-19. The items measure physiologically-based symptoms that are aroused with coronavirus-related information and thoughts using a 5-point time anchored scale (0=not at all to 4=nearly every day over the last 2 weeks). | During the intervention, at day 1. | 
| Differences in fear of Coronavirus Disease (COVID-19) using the Fear COVID-19 Scale (FCV-19S) | The Fear of COVID-19 Scale (FCV-19S) is used to identify and intervene early, psychologically, in people with high values of fear of COVID-19. This one-dimensional scale is made up of seven items with a 5-point Likert response ranging from 1 (strongly disagree) to 5 (strongly agree) and the total tables can range between 7 and 35 points. The higher the score, the greater the fear of COVID-19 infection. | During the intervention, at day 1. | 
| Objective differences in physical activity, sedentary lifestyle and sleep using the accelerometer technique (ActiGraph) | An accelerometer is a small device, like a wristwatch, used to measure physical activity level, patterns of activity, sedentary levels, sleep patterns, and the expenditure of calories consumed, basal and total Metabolic Equivalent of Task (METs) used as an assessment of the metabolism of the person wearing it. | Up to 1 week | 
| Determination of immuno-neuroendocrine parameters (cytokines, catecholamines, and stress hormones) | Cytokines (IL-8, IL-10), catecholamines (such as epinephrine, and norepinephrine) as well as stress hormones (serotonin and cortisol), were analyzed by competitive inhibition enzyme immunoassays (ELISA) | Through study completion, an average of 2 year |