Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
CompletedNot applicableNCT05932433
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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: 1. Attend the 12 therapeutic exercise sessions 2. 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: 1. The Ronald Morris Disability Questionnaire (RMDQ) 2. Anxiety (State-Trait Anxiety Inventory (STAI)) 3. Depression: Beck Depression Inventory (BDI) 4. Quality of Life: SF-12 5. Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI) 6. Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM) 7. 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.
Study details
- Official title
- Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
- Conditions
- Arthritis
- Fibromyalgia
- Arthritis Rheumatoid
- Artrosis of the Knee
- Chronic Pain
- Central Sensitisation
- Gut Microbiota
- Exercise Therapy
- Interventions
- Sponsor
- Universidad Rey Juan Carlos
- Start date
- 2023-05-01
- Primary completion
- 2023-06-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05932433