Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT05932433
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.
Study:
NCT05932433
Study Brief:
Protocol Section:
NCT05932433