ArthritisMiBioPainNCT05932433
Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
A study testing Exercise in people with Arthritis and Fibromyalgia, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Fibromyalgia, Arthritis Rheumatoid
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2023to 10 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be at least 18 years old
- Must be diagnosed with: osteoarthritis, osteoarthritis, Sudeck or fibromyalgia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Arthritis, Fibromyalgia, Arthritis Rheumatoid, Artrosis of the Knee, Chronic Pain, Central Sensitisation
- Being tested
- Exercise
- Medical subject headings
- Arthritis, Fibromyalgia, Arthritis, Rheumatoid, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Therapeutic exercise, physical activity
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise during 6 weeks, twice a week. Receives: Behavioral: Exercise |
| Control | No intervention | There is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Sensory Test (QST), and
Conditioned Pain Modulation (CPM) and pain threshold will be assesed as measured of QST.
Measured: 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.
Measured: From enrollment to the end of the intervention at 6 weeks
Descriptive parameters
Descriptive parameters of the sample will be explain in a table
Measured: From enrollment to the end of the intervention at 6 weeks
Secondary outcomes (1)
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
Measured: From enrollment to the end of the intervention at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 May 2023
- Primary completion1 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Elena González Álvarez, Universidad Rey Juan Carlos
- Investigators
- Jorge H Jorge Hugo Villafañe, Dr., Study director, Responsable científico, Centro "S. Maria ai Colli" - Presidio Ospedaliero "Ausiliatrice", Torino, de la Fondazione Don Carlo Gnocchi Onlus, Italia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932433
- Sponsor's protocol ID
- 1601202303523
- Acronym
- MiBioPain
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and its interpretation are going to be publicated in the Scientific Community through specific and scientific Journals about this topic and Congress.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
- ClinicalTrials.gov ID
- NCT05932433
- Acronym / sponsor ID
- MiBioPain / 1601202303523
- Conditions
- Arthritis, Fibromyalgia, Arthritis Rheumatoid, Artrosis of the Knee, Chronic Pain, Central Sensitisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseExercise during 6 weeks, twice a week. |
| Control | No intervention | –There is no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be at least 18 years old
- Must be diagnosed with: osteoarthritis, osteoarthritis, Sudeck or fibromyalgia.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Therapeutic exercise, physical activityEach 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. | Behavioural | Exercise |
Primary outcome
Quantitative Sensory Test (QST), and
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of the intervention at 6 weeks
Descriptive parameters of the sample will be explain in a table
1 secondary outcome
Interleukin analysis
Time frame: From enrollment to the end of the intervention at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: Yes. Data and its interpretation are going to be publicated in the Scientific Community through specific and scientific Journals about this topic and Congress.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge H Jorge Hugo Villafañe, Dr. study director
Responsable científico, Centro "S. Maria ai Colli" - Presidio Ospedaliero "Ausiliatrice", Torino, de la Fondazione Don Carlo Gnocchi Onlus, Italia.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Arthritis and Fibromyalgia, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Sensory Test (QST), and (time frame: From enrollment to the end of the intervention at 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.