Ignite Creation Date:
2024-05-06 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05932433
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2023-06-22
Brief Title:
Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients
Sponsor:
Universidad Rey Juan Carlos
Organization:
Universidad Rey Juan Carlos
Study Overview
Official Title:
Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MiBioPain
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 6792016 of April 27 general data protection as well as Organic Law 32018 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
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 6792016 of April 27 general data protection as well as Organic Law 32018 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None