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

Sponsor
Universidad Rey Juan Carlos (Other)
Overall Status
Completed
CT.gov ID
NCT05932433
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
1.3
Actual Duration (Months)
45.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
Actual Study Start Date :
May 1, 2023
Actual Primary Completion Date :
Jun 1, 2023
Actual Study Completion Date :
Jun 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise

Exercise during 6 weeks, twice a week.

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.
Other Names:
  • Therapeutic exercise
  • physical activity

    		•
    No Intervention: Control

    There is no intervention

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidad Rey Juan Carlos Alcorcón Madrid Spain 28922

    Sponsors and Collaborators

    • Universidad Rey Juan Carlos

    Investigators

    • Study Director: 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    María Elena González Álvarez, Principal Investigator, Universidad Rey Juan Carlos
    ClinicalTrials.gov Identifier:
    NCT05932433
    Other Study ID Numbers:
    • 1601202303523
    First Posted:
    Jul 6, 2023
    Last Update Posted:
    Jul 6, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Fibromyalgia
    Arthritis, Rheumatoid
    Chronic Pain

    Study Results

    No Results Posted as of Jul 6, 2023