Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
All Genders
NCT06923800

Exercise Interventions and Dietary Advice in Fibromyalgia and IBS

Led by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Updated on 2026-03-27

30

Participants Needed

1

Research Sites

189 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness. Central sensitization plays a key role, making the nervous system more responsive to pain. Though muscles are mainly affected, joint pain, stiffness, and reduced mobility are also common. Chronic pain and poor posture can worsen musculoskeletal health. FM is not mainly inflammatory, but pain and stress may affect bone health. Sleep disorders, like non-restorative sleep and apnea, are frequent and worsen fatigue. Neurotransmitter imbalances (e.g., serotonin, dopamine) affect pain and muscle function. The American College of Rheumatology defines FM by widespread bilateral pain lasting at least three months. FM mainly affects women, with a prevalence of 0.2-6.6%, often starting between the ages of 30 and 35. Besides physical symptoms, many patients suffer from anxiety, depression, and mood disorders, affecting their quality of life. Gastrointestinal issues, especially irritable bowel syndrome (IBS), are also frequent in FM patients. Both conditions share mechanisms such as pain hypersensitivity, altered autonomic regulation, gut-brain axis disruption, and immune dysfunction. Low-grade inflammation and intestinal permeability may contribute to chronic symptoms. FM treatment includes anticonvulsants, antidepressants, and painkillers. IBS is managed with diet changes and medications like antispasmodics. Due to limited drug effectiveness, multidisciplinary approaches are gaining attention. Physical exercise is a proven non-drug strategy that improves pain, fatigue, and mental health in FM and IBS. Still, adherence is low due to fear of pain, fatigue, and low motivation. Exercise, especially aerobic activity, benefits IBS patients by improving gut symptoms and reducing inflammation. It may also strengthen the gut barrier in both conditions. While optimal programs need more study, exercise is a promising therapy. Major health bodies recommend aerobic, resistance, and flexibility training for FM and aerobic exercise for IBS.

CONDITIONS

Official Title

Exercise Interventions and Dietary Advice in Fibromyalgia and IBS

Who Can Participate

Age: 30Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of irritable bowel syndrome and fibromyalgia according to official criteria
  • Moderate to severe IBS symptoms with IBS-SSS score of 125 or higher
  • Men and women aged 30 to 65 years
  • Body mass index (BMI) between 18.5 and 29.9
Not Eligible

You will not qualify if you...

  • Severe cardiac, liver, neurological, psychiatric, or other gastrointestinal diseases
  • Unable to stop symptom treatments or medications for fibromyalgia or IBS

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Saverio de Bellis

Castellana Grotte, Bari, Italy, 70013

Actively Recruiting

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Research Team

A

Antonella Bianco

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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