Exercise, Irritable Bowel Syndrome and Fibromyalgia

NCT06166563 | Completed

• 1 other identifier: AF-FM 01
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia; Irritable Bowel Syndrome; Exercise; Gastrointestinal Functions; Physical Activity

Outcome Measures

Primary Outcomes (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).

  At baseline and day 120

• 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

Secondary Outcomes (5)

• Psychological Assessment:

  At baseline and day 120

• Gastroduodenal permeability

  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 (3)

AF-FM

ACTIVE COMPARATOR

Patients with Fibromyalgia

Behavioral: Exercise Program

AF-IBS

ACTIVE COMPARATOR

Patients with irritable bowel syndrome

Behavioral: Exercise Program

AF-FM-IBS

ACTIVE COMPARATOR

Patients with fibromyalgia and irritable bowel syndrome

Behavioral: Exercise Program

Interventions

Exercise Program BEHAVIORAL

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

AF-FM; AF-FM-IBS; AF-IBS

Eligibility Criteria

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

You may qualify if:

• Satisfaction of the ACR diagnostic criteria for the diagnosis of FM,
• A total Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) score of ≥ 125 (moderate to severe IBS symptoms) for the satisfaction of the Rome III-IV criteria in patients with IBS.

You may not qualify if:

• Serious cardiac, hepatic, neurological, psychiatric, or gastrointestinal diseases other than IBS (e.g., inflammatory bowel disease, diverticular disease/diverticulitis) that could explain the current symptoms.
• Specific therapy for symptoms due to pathologies (educational programs, alternative medicine, psychotherapy). In the case of subjects who were previously undergoing treatment, they may participate in the study provided they suspend the ongoing therapy until the symptoms reappear.
• The use of drugs to treat FM and IBS.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

IRCCS Saverio de Bellis

Castellana Grotte, Bari, 70013, Italy

Location

Related Publications (19)

• Foster C, Porcari JP, Anderson J, Paulson M, Smaczny D, Webber H, Doberstein ST, Udermann B. The talk test as a marker of exercise training intensity. J Cardiopulm Rehabil Prev. 2008 Jan-Feb;28(1):24-30; quiz 31-2. doi: 10.1097/01.HCR.0000311504.41775.78.

  PMID: 18277826 BACKGROUND

• Jones KD, Clark SR, Bennett RM. Prescribing exercise for people with fibromyalgia. AACN Clin Issues. 2002 May;13(2):277-93. doi: 10.1097/00044067-200205000-00012.

  PMID: 12011599 BACKGROUND

• Kingsley JD, McMillan V, Figueroa A. The effects of 12 weeks of resistance exercise training on disease severity and autonomic modulation at rest and after acute leg resistance exercise in women with fibromyalgia. Arch Phys Med Rehabil. 2010 Oct;91(10):1551-7. doi: 10.1016/j.apmr.2010.07.003.

  PMID: 20875513 BACKGROUND

• Mannerkorpi K, Iversen MD. Physical exercise in fibromyalgia and related syndromes. Best Pract Res Clin Rheumatol. 2003 Aug;17(4):629-47. doi: 10.1016/s1521-6942(03)00038-x.

  PMID: 12849716 BACKGROUND

• Rooks DS. Talking to patients with fibromyalgia about physical activity and exercise. Curr Opin Rheumatol. 2008 Mar;20(2):208-12. doi: 10.1097/BOR.0b013e3282f5687a.

  PMID: 18349753 BACKGROUND

• Tanaka H, Monahan KD, Seals DR. Age-predicted maximal heart rate revisited. J Am Coll Cardiol. 2001 Jan;37(1):153-6. doi: 10.1016/s0735-1097(00)01054-8.

  PMID: 11153730 BACKGROUND

• Valkeinen H, Alen M, Hannonen P, Hakkinen A, Airaksinen O, Hakkinen K. Changes in knee extension and flexion force, EMG and functional capacity during strength training in older females with fibromyalgia and healthy controls. Rheumatology (Oxford). 2004 Feb;43(2):225-8. doi: 10.1093/rheumatology/keh027. Epub 2003 Sep 16.

  PMID: 13130154 BACKGROUND

• Valkeinen H, Hakkinen A, Hannonen P, Hakkinen K, Alen M. Acute heavy-resistance exercise-induced pain and neuromuscular fatigue in elderly women with fibromyalgia and in healthy controls: effects of strength training. Arthritis Rheum. 2006 Apr;54(4):1334-9. doi: 10.1002/art.21751.

  PMID: 16575859 BACKGROUND

• Wilson RC, Jones PW. A comparison of the visual analogue scale and modified Borg scale for the measurement of dyspnoea during exercise. Clin Sci (Lond). 1989 Mar;76(3):277-82. doi: 10.1042/cs0760277.

  PMID: 2924519 BACKGROUND

• Linsalata M, Riezzo G, D'Attoma B, Clemente C, Orlando A, Russo F. Noninvasive biomarkers of gut barrier function identify two subtypes of patients suffering from diarrhoea predominant-IBS: a case-control study. BMC Gastroenterol. 2018 Nov 6;18(1):167. doi: 10.1186/s12876-018-0888-6.

  PMID: 30400824 BACKGROUND

• Barsky AJ, Borus JF. Functional somatic syndromes. Ann Intern Med. 1999 Jun 1;130(11):910-21. doi: 10.7326/0003-4819-130-11-199906010-00016.

  PMID: 10375340 BACKGROUND

• Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.

  PMID: 24737367 BACKGROUND

• Martinez-Lavin M. Biology and therapy of fibromyalgia. Stress, the stress response system, and fibromyalgia. Arthritis Res Ther. 2007;9(4):216. doi: 10.1186/ar2146.

  PMID: 17626613 BACKGROUND

• Akkaya N, Akkaya S, Atalay NS, Balci CS, Sahin F. Relationship between the body image and level of pain, functional status, severity of depression, and quality of life in patients with fibromyalgia syndrome. Clin Rheumatol. 2012 Jun;31(6):983-8. doi: 10.1007/s10067-012-1965-9. Epub 2012 Mar 7.

  PMID: 22395855 BACKGROUND

• Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.

  PMID: 33024295 BACKGROUND

• Kim YS. Why should gastroenterologists know about fibromyalgia? Common pathogenesis and clinical implications. J Neurogastroenterol Motil. 2011 Jan;17(1):1-3. doi: 10.5056/jnm.2011.17.1.1. Epub 2011 Jan 26. No abstract available.

  PMID: 21369484 BACKGROUND

• Johannesson E, Jakobsson Ung E, Sadik R, Ringstrom G. Experiences of the effects of physical activity in persons with irritable bowel syndrome (IBS): a qualitative content analysis. Scand J Gastroenterol. 2018 Oct-Nov;53(10-11):1194-1200. doi: 10.1080/00365521.2018.1519596. Epub 2018 Nov 25.

  PMID: 30472905 BACKGROUND

• Russo F, Riezzo G, Linsalata M, Orlando A, Tutino V, Prospero L, D'Attoma B, Giannelli G. Managing Symptom Profile of IBS-D Patients With Tritordeum-Based Foods: Results From a Pilot Study. Front Nutr. 2022 Feb 15;9:797192. doi: 10.3389/fnut.2022.797192. eCollection 2022.

  PMID: 35242794 BACKGROUND

• Russo F, Riezzo G, Orlando A, Linsalata M, D'Attoma B, Prospero L, Ignazzi A, Giannelli G. A Comparison of the Low-FODMAPs Diet and a Tritordeum-Based Diet on the Gastrointestinal Symptom Profile of Patients Suffering from Irritable Bowel Syndrome-Diarrhea Variant (IBS-D): A Randomized Controlled Trial. Nutrients. 2022 Apr 8;14(8):1544. doi: 10.3390/nu14081544.

  PMID: 35458106 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Irritable Bowel Syndrome; Motor Activity

Interventions

Resistance Training

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)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Francesco Russo

  National Institute for Digestive Diseases IRCCS " Saverio de Bellis"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 12, 2023
• Study Start: September 4, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)