Exercise Interventions and Dietary Advice in Fibromyalgia and IBS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Individuals with severe cardiac, hepatic, neurological, psychiatric disorders, or other gastrointestinal diseases.

Individuals unable to discontinue symptom management therapies and medications for FM/IBS.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: FM+IBS Group 1Experimental treatment 2 interventions
Group B: FM + IBS Group 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline and day 120
2

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).

Time frame
At baseline and day 120

Secondary outcomes

1

Physical Fitness assessment

Field tests to assess participants' physical fitness include the 2 km Walk Test, which evaluates cardiovascular fitness by recording heart rate and walking time before and after the test. The Six-Minute Walk Test measures aerobic fitness and functional capacity, requiring participants to walk as far as possible in 6 minutes, with heart rate monitored and exertion assessed using the Borg Scale. The Hand Grip Test assesses maximum hand and forearm strength using a dynamometer, with three tests per hand and the average recorded. The Sit and Reach Test measures flexibility in the back and legs, recording the best of two attempts. The 30-second Sit to Stand Test evaluates lower limb strength and endurance by counting the number of complete sit-to-stand movements in 30 seconds without using arms for support. The Step Test assesses cardiovascular endurance and lower limb function by having participants repeatedly step onto a standard-height step for 3 minutes, with recovery heart rate record

Time frame
Al Baseline and day 120
2

Psychological Assessment:

The Symptom Checklist (SCL)-90-R questionnaire will evaluate the psychological profile The Symptom Checklist-90-Revised (SCL-90-R) is a widely employed self-report questionnaire in clinical and research settings. It aims to evaluate diverse psychological symptoms and distress in individuals. Comprising 90 items, the SCL-90-R addresses dimensions of psychological well-being and psychopathology, including somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. Respondents use a Likert scale ranging from 0 (not at all) to 4 (extremely) to rate the extent of their experience with each symptom over a specified timeframe, typically the past week. This questionnaire offers a comprehensive profile of an individual's psychological symptoms, aiding in identifying areas of distress or dysfunction.

Time frame
At baseline and day 120
3

Evaluation of Barrier Peptide Integrity

Zonulin, I-FABP, DAO, and D-lactate assays will be performed using commercially available ELISA assays for each peptide.

Time frame
At baseline and day 120
4

Intestinal microbiota analysis

Any differences in the intestinal microbial population in the different disease patterns considered will be evaluated using appropriate genetic and molecular investigations (Illumina/Solexa Genetic Analyzer HiSeq) on the patient's stool samples.

Time frame
At baseline and day 120

Other outcomes

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