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Exercise, Irritable Bowel Syndrome and Fibromyalgia

NCT06166563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

  • Fibromyalgia
  • Irritable Bowel Syndrome

Interventions

BEHAVIORAL

Exercise Program

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

Sponsors & Collaborators

  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    lead OTHER

Principal Investigators

  • Francesco Russo · National Institute for Digestive Diseases IRCCS " Saverio de Bellis"

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06166563 on ClinicalTrials.gov