CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 165 enrolled
Drug / intervention
Exercise Programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06166563
NCT06166563N/ACompleted

Effects of Indoor Activity on the Integrity and Function of the Intestinal Barrier of Patients With Fibromyalgia and Irritable Bowel Syndrome

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis·interventional·Posted Dec 12, 2023·Updated Mar 25, 2026

In Brief

A clinical study evaluating Exercise Program for Fibromyalgia and Irritable Bowel Syndrome. Completed, enrolled 165 participants across 1 site.

Detailed Summary

The project focuses on "somatic functional syndrome", a category of disorders characterized by subjective symptoms, suffering and disability without evident organic or functional alterations. Syndromes such as Fibromyalgia, Irritable Bowel, Chronic Fatigue and Restless Legs fall into this category. Patients seek diagnoses and treatments, often consulting multiple doctors. The proposed alternative approach involves physical activity as the cornerstone of therapy, with a focus on fibromyalgia. Fibromyalgia manifests itself with musculoskeletal pain, chronic fatigue, sleep disturbances and other symptoms. The text highlights a correlation between fibromyalgia and gastrointestinal disorders, in particular Irritable Bowel. Both syndromes share pathophysiological mechanisms, including alteration of intestinal permeability and psychosocial factors. An important note is the possible compromise of the integrity of the intestinal wall, with consequences on general health. Inflammation, dysbiosis, and altered intestinal permeability contribute to a vicious cycle that can lead to cardiovascular, neurodegenerative, and inflammatory diseases. Regular physical activity is a possible improvement for fibromyalgia symptoms, with scientific studies demonstrating its effectiveness. A sedentary lifestyle is linked to gastrointestinal problems, and physical exercise can promote gastrointestinal motility and counteract disorders such as gastric reflux and irritable bowel syndrome. The research aims to focus on the effects of physical activity on gastrointestinal and extra-gastrointestinal symptoms in patients with fibromyalgia and irritable bowel disease. The effects on intestinal integrity, dysbiosis and markers of inflammation are also examined. The research also aims to evaluate the psychological aspects of these syndromes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedDec 12, 2023
Enrollment StartSep 4, 2023
Primary CompletionSep 30, 2025
Study CompletionDec 31, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 2.6 years ago

Interventions

Exercise Programbehavioral

The intervention includes an individualized exercise program in Frequency, Intensity, Time, and Type (FITT).