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

NCT05932433 | Completed

• 1 other identifier: 1601202303523
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Attend the 12 therapeutic exercise sessions
2. 2.Attend the 3 evaluations: at the beginning (A0), post intervention (A1) and +6 weeks after finishing the exercise program (A3).
3. 3.The Ronald Morris Disability Questionnaire (RMDQ)
4. 4.Anxiety (State-Trait Anxiety Inventory (STAI))
5. 5.Depression: Beck Depression Inventory (BDI)
6. 6.Quality of Life: SF-12
7. 7.Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI)
8. 8.Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM)
9. 9.Perform a pre blood test on interleukins IL-18 and IL-1β

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Interleukin analysis

  From enrollment to the end of the intervention at 6 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Exercise during 6 weeks, twice a week.

Behavioral: Exercise

Control

NO INTERVENTION

There is no intervention

Interventions

Exercise BEHAVIORAL

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.

Also known as: Therapeutic exercise, physical activity

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at least 18 years old
• Must be diagnosed with: osteoarthritis, osteoarthritis, Sudeck or fibromyalgia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Arthritis; Fibromyalgia; Arthritis, Rheumatoid; Chronic Pain

Interventions

Exercise; Exercise Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 6, 2023
• Study Start: May 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 10, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (1)