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

Universidad Rey Juan Carlos

Status: Completed

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

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05932433

1601202303523

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Exercise

Experimental group

Description:

Exercise during 6 weeks, twice a week.

Treatment:

Behavioral: Exercise

Control

No Intervention group

Description:

There is no intervention