Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients. (MiBioPain)
Primary Purpose
Arthritis, Fibromyalgia, Arthritis Rheumatoid
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis
Eligibility Criteria
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.
Sites / Locations
- Universidad Rey Juan Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Control
Arm Description
Exercise during 6 weeks, twice a week.
There is no intervention
Outcomes
Primary Outcome Measures
Quantitative Sensory Test (QST), and
Conditioned Pain Modulation (CPM) and pain threshold will be assesed as measured of QST.
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.
Descriptive parameters
Descriptive parameters of the sample will be explain in a table
Secondary Outcome Measures
Interleukin analysis
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
Full Information
NCT ID
NCT05932433
First Posted
June 22, 2023
Last Updated
June 30, 2023
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT05932433
Brief Title
Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
Acronym
MiBioPain
Official Title
Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
Attend the 12 therapeutic exercise sessions
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:
The Ronald Morris Disability Questionnaire (RMDQ)
Anxiety (State-Trait Anxiety Inventory (STAI))
Depression: Beck Depression Inventory (BDI)
Quality of Life: SF-12
Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI)
Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Fibromyalgia, Arthritis Rheumatoid, Artrosis of the Knee, Chronic Pain, Central Sensitisation, Gut Microbiota, Exercise Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise during 6 weeks, twice a week.
Arm Title
Control
Arm Type
No Intervention
Arm Description
There is no intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Therapeutic exercise, physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quantitative Sensory Test (QST), and
Description
Conditioned Pain Modulation (CPM) and pain threshold will be assesed as measured of QST.
Time Frame
From enrollment to the end of the intervention at 6 weeks
Title
Psychological and PainTest
Description
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.
Time Frame
From enrollment to the end of the intervention at 6 weeks
Title
Descriptive parameters
Description
Descriptive parameters of the sample will be explain in a table
Time Frame
From enrollment to the end of the intervention at 6 weeks
Secondary Outcome Measure Information:
Title
Interleukin analysis
Description
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
Time Frame
From enrollment to the end of the intervention at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge H Jorge Hugo Villafañe, Dr.
Organizational Affiliation
Responsable científico, Centro "S. Maria ai Colli" - Presidio Ospedaliero "Ausiliatrice", Torino, de la Fondazione Don Carlo Gnocchi Onlus, Italia.
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and its interpretation are going to be publicated in the Scientific Community through specific and scientific Journals about this topic and Congress.
Learn more about this trial
Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
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