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

Not Applicable

Completed

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

• Registration Number: NCT05932433
• Lead Sponsor: Universidad Rey Juan Carlos

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2023-06
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-10
• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Study First Posted: 2023-07-06
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Exercise during 6 weeks, twice a week.

Primary Outcome Measures

Name	Time	Method
Quantitative Sensory Test (QST), and	From enrollment to the end of the intervention at 6 weeks	Conditioned Pain Modulation (CPM) and pain threshold will be assesed as measured of QST.
Psychological and PainTest	From enrollment to the end of the intervention at 6 weeks	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.
Descriptive parameters	From enrollment to the end of the intervention at 6 weeks	Descriptive parameters of the sample will be explain in a table

Secondary Outcome Measures

Name	Time	Method
Interleukin analysis	From enrollment to the end of the intervention at 6 weeks	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

Trial Locations

Locations (1)

Universidad Rey Juan Carlos; 🇪🇸 Alcorcón, Madrid, Spain