Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.

Study Overview
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Brief Summary
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This study aims to evaluate the effect of therapeutic exercise on the gut microbiome in chronic widespread pain patients. Our investigation purpose is to improve the quality of life of participants, reduce their disability and optimize their functionality. The intervention will last 6 weeks, with 2 face-to-face therapeutic exercise sessions guided by a professional and a 6-week post-intervention follow-up. The participation will require: Attend the 12 therapeutic exercise sessions Attend the 3 evaluations: at the beginning (A0), post intervention (A1) and +6 weeks after finishing the exercise program (A3). The items to be evaluated will be the following: The Ronald Morris Disability Questionnaire (RMDQ) Anxiety (State-Trait Anxiety Inventory (STAI)) Depression: Beck Depression Inventory (BDI) Quality of Life: SF-12 Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI) Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM) Perform a pre blood test on interleukins IL-18 and IL-1β This study involves the processing of personal data, so the researchers will guarantee confidentiality in their treatment at all times, complying with the personal data protection regulations, in particular, European Regulation 679/2016. , of April 27, general data protection, as well as Organic Law 3/2018, of December 5, Protection of Personal Data and Guarantee of Digital Rights. In order to maintain your privacy and anonymity during the research, only one person on the research team will know how names were assigned to a participation number.

Official Title
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Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.

Conditions
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Arthritis, Fibromyalgia, Arthritis Rheumatoid, Artrosis of the Knee, Chronic Pain, Central Sensitisation, Gut Microbiota, Exercise Therapy

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be at least 18 years old Must be diagnosed with: osteoarthritis, osteoarthritis, Sudeck or fibromyalgia. Exclusion Criteria: Suffering or having suffered from cancer, psychiatric disorders, or another ongoing major illness (irritable bowel syndrome, hepatitis, Lyme disease or diabetes). Patients will be excluded if they have more than 6 points on the Beck Depression Inventory, more than 30 points on the State Trait Anxiety Inventory or suffer from dementia.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Exercise during 6 weeks, twice a week. | Behavioral: Exercise<br>* Each session (45 minutes aprox) is made by: mobility, endurance and final exercise to rest. The sesion is going to perform twice a week during 6 weeks.<br>* Other names: physical activity;|
| No Intervention: Control<br>There is no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Sensory Test (QST), and | Conditioned Pain Modulation (CPM) and pain threshold will be assesed as measured of QST. | From enrollment to the end of the intervention at 6 weeks | 
| Psychological and PainTest | Furthermore,Beck Depression Inventory and State-Trait Anxiety Inventory (STAI) will be perform as a psychological test. The Brief Pain Inventory (BPI) and a numerical rate scale will be perform as a pain tests. | From enrollment to the end of the intervention at 6 weeks | 
| Descriptive parameters | Descriptive parameters of the sample will be explain in a table | From enrollment to the end of the intervention at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin analysis | Interleukin-18 and interleukin-1β analysis will be perform in tha baseline in control group and at the end of the intervention in the experimental (exercise) group | From enrollment to the end of the intervention at 6 weeks |