RecruitingNot ApplicableNCT06923800

Exercise Interventions and Dietary Advice in Fibromyalgia and IBS

Comparison of Two Exercise Interventions and Dietary Advice in Patients With Fibromyalgia and Irritable Bowel Syndrome: A Randomized Controlled Crossover Study


Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Enrollment

30 participants

Start Date

Apr 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 30 YearsMax Age: 65 Years

Inclusion Criteria4

  • Confirmed diagnosis of Irritable Bowel Syndrome (IBS) concomitant with Fibromyalgia (FM).Meeting the American College of Rheumatology (ACR) diagnostic criteria for FM and meeting the Rome III/IV diagnostic criteria for IBS.
  • Total score on the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) ≥ 125 (indicating moderate to severe IBS symptoms).
  • Men and women aged between 30 and 65 years.
  • Body Mass Index (BMI) between 18.5 and 29.9.

Exclusion Criteria2

  • Individuals with severe cardiac, hepatic, neurological, psychiatric disorders, or other gastrointestinal diseases.
  • Individuals unable to discontinue symptom management therapies and medications for FM/IBS.

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Interventions

BEHAVIORALCombined Exercise Program + A specific nutritional plan for individuals with IBS

60-minute sessions three times per week for 4 months, incorporating moderate aerobic, resistance, and flexibility exercises

BEHAVIORALAerobic Exercise + A specific nutritional plan for individuals with IBS

60-minute sessions, three times a week for 4 months, with low-impact, non-weight-bearing aerobic activities at 60-75% of max heart rate.


Locations(1)

IRCCS Saverio de Bellis

Castellana Grotte, Bari, Italy

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NCT06923800


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