Exercise for managing Fibromyalgia and Irritable Bowel Syndrome
Effects of Indoor Activity on the Integrity and Function of the Intestinal Barrier of Patients With Fibromyalgia and Irritable Bowel Syndrome
This study is testing whether a specific exercise program can help adults with Fibromyalgia and Irritable Bowel Syndrome feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Locations | 1 site (Castellana Grotte, Bari) |
| Trial ID | NCT06166563 on ClinicalTrials.gov |
What this trial studies
This project investigates the effects of physical activity as a primary treatment for patients suffering from Fibromyalgia and Irritable Bowel Syndrome. It aims to recruit adult outpatients aged 18-65 from specialized clinics, focusing on those with either condition or both comorbidities. Participants will undergo a comprehensive health assessment and maintain a daily symptom diary to track their progress. The study will evaluate the impact of an exercise program on their symptoms and overall health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 diagnosed with Fibromyalgia, Irritable Bowel Syndrome, or both.
Not a fit: Patients with serious cardiac, hepatic, neurological, psychiatric, or gastrointestinal diseases other than IBS may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from Fibromyalgia and Irritable Bowel Syndrome.
How similar studies have performed: Previous studies have shown promising results for exercise interventions in managing symptoms of Fibromyalgia and Irritable Bowel Syndrome, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Satisfaction of the ACR diagnostic criteria for the diagnosis of FM, * A total Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) score of ≥ 125 (moderate to severe IBS symptoms) for the satisfaction of the Rome III-IV criteria in patients with IBS. Exclusion Criteria: * Serious cardiac, hepatic, neurological, psychiatric, or gastrointestinal diseases other than IBS (e.g., inflammatory bowel disease, diverticular disease/diverticulitis) that could explain the current symptoms. * Specific therapy for symptoms due to pathologies (educational programs, alternative medicine, psychotherapy). In the case of subjects who were previously undergoing treatment, they may participate in the study provided they suspend the ongoing therapy until the symptoms reappear. * The use of drugs to treat FM and IBS.
Where this trial is running
Castellana Grotte, Bari
- IRCCS Saverio de Bellis — Castellana Grotte, Bari, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Russo — National Institute for Digestive Diseases IRCCS " Saverio de Bellis"
- Study coordinator: Francesco Russo
- Email: francesco.russo@irccsdebellis.it
- Phone: +390804994129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.