Exercise Interventions and Dietary Advice in Fibromyalgia and IBS

NCT06923800 | Recruiting

• 1 other identifier: AF_FM crossover
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia; Irritable Bowel Syndrome

Keywords

exercise; aerobic exercise; fibromyalgia; irritable bowel syndrome

Outcome Measures

Primary Outcomes (2)

• Fibromyalgia symptom assesment

  To evaluate the effectiveness of an exercise intervention on IBS symptoms as measured by a change in the Fibromyalgia Impact Questionnaire, modified version (FIQ-R) scores from baseline. The FIQ serves as a tool for assessing and evaluating the condition of patients with fibromyalgia (FM) and tracking their progress and outcomes. Specifically designed to gauge the aspects of health status most impacted by FM, the FIQ comprises ten items. The initial item consists of 11 questions about physical functioning, each rated on a 4-point Likert-type scale. The subsequent items (2 and 3) prompt patients to indicate the number of days they felt well and the days they were unable to engage in work or housework due to FM symptoms. Items 4 through 10 feature horizontal linear scales with ten increments, allowing patients to rate work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression.

  At baseline and day 120

• IBS symptoms assessment

  To evaluate the effectiveness of an exercise intervention on IBS symptoms as measured by a change in the IBS-Symptom Severity Scale (IBS-SSS) questionnaire score from baseline. The IBS-SSS is a validated questionnaire for gastrointestinal symptoms and provides a global measure of symptom severity by assessing five items ("severity of abdominal pain", "frequency of abdominal pain", "severity of abdominal distension", "dissatisfaction with bowel habits", "impact of symptoms on quality of life") on a visual analog scale. The values of the five items are added together to give a total score between 0 and 500. Cases are then classified as 'mild' (75 to 175), 'moderate' (175 to 300) and 'severe' (\>300).

  At baseline and day 120

Secondary Outcomes (5)

• Physical Fitness assessment

  Al Baseline and day 120

• Psychological Assessment:

  At baseline and day 120

• Evaluation of Barrier Peptide Integrity

  At baseline and day 120

• Intestinal microbiota analysis

  At baseline and day 120

• Evaluation of Intestinal dysbiosis

  At baseline and day 120

Study Arms (2)

FM+IBS Group 1

EXPERIMENTAL

Patients with Fibromyalgia and IBS

Behavioral: Combined Exercise Program + A specific nutritional plan for individuals with IBS; Behavioral: Aerobic Exercise + A specific nutritional plan for individuals with IBS

FM + IBS Group 2

EXPERIMENTAL

Patients with Fibromyalgia and IBS

Behavioral: Combined Exercise Program + A specific nutritional plan for individuals with IBS; Behavioral: Aerobic Exercise + A specific nutritional plan for individuals with IBS

Interventions

Combined Exercise Program + A specific nutritional plan for individuals with IBS BEHAVIORAL

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

FM + IBS Group 2; FM+IBS Group 1

Aerobic Exercise + A specific nutritional plan for individuals with IBS BEHAVIORAL

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.

FM + IBS Group 2; FM+IBS Group 1

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

IRCCS Saverio de Bellis

Castellana Grotte, Bari, 70013, Italy

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Irritable Bowel Syndrome; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Antonella Bianco

CONTACT

+390804994653; antonella.bianco@irccsdebellis.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: first treatment assignment is randomized
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (1)