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

Summary

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.

Conditions

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

Interventions

BEHAVIORAL

Exercise

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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos

  lead OTHER

Principal Investigators

• Jorge H Jorge Hugo Villafañe, Dr. · Responsable científico, Centro "S. Maria ai Colli" - Presidio Ospedaliero "Ausiliatrice", Torino, de la Fondazione Don Carlo Gnocchi Onlus, Italia.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-01

Primary Completion

2023-06-01

Completion

2023-06-10

Countries

• Spain

Study Locations