Exercise and Irritable Bowel Syndrome (IBS)

NCT05453084 | Completed

• 1 other identifier: IRCCSDebellis
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim 1: As shown in the literature, exercise can be a useful tool for treating and improving functional GI disorders. Therefore, the aim is to estimate the effectiveness of an exercise intervention on IBS symptoms as measured by a reduction of at least 50 score points on the IBS- Symptom Severity Scale (IBS-SSS) questionnaire.

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome; Exercise; Gastrointestinal Function; Physical activity

Outcome Measures

Primary Outcomes (1)

• Symptom 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 analogue 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).

  Baseline and after 3 months

Secondary Outcomes (3)

• Gatroduodenal permeability

  Baseline and after 3 months

• Evaluation of Barrier peptide integrity

  Baseline and after 3 months

• Intestinal microbiota analysis

  Baseline and after 3 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

The exercise intervention tool will be Fitwalking, which is structured, organized, supervised and administered through a "Walking Group"

Behavioral: Exercise Program

Interventions

Exercise Program BEHAVIORAL

The intervention includes an individualized exercise program in terms of Frequency, Intensity, Time, Type, Volume and Progression (FITT-VP).

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients referred to the "Outpatient Clinic for Celiac Disease and Functional Disorders" who meet the Rome III-IV criteria for IBS-D and referred by their local General Practitioner.

You may not qualify if:

• Presence of severe heart, liver, neurological or psychiatric disease or GI disease other than IBS (e.g., inflammatory bowel disease, celiac disease) that could explain the current symptoms.
• Patients who have previously followed a diet low in particular substances (e.g., low FODMAPs, vegan diet, gluten-free diet).
• Antidepressant use

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

Laboratory of Epidemiology and Statistic- IRCCS De Bellis

Castellana Grotte, Bari, 70013, Italy

Location

Related Publications (37)

• Orlando A, Tutino V, Notarnicola M, Riezzo G, Linsalata M, Clemente C, Prospero L, Martulli M, D'Attoma B, De Nunzio V, Russo F. Improved Symptom Profiles and Minimal Inflammation in IBS-D Patients Undergoing a Long-Term Low-FODMAP Diet: A Lipidomic Perspective. Nutrients. 2020 Jun 2;12(6):1652. doi: 10.3390/nu12061652.

  PMID: 32498383 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

• Johannesson E, Simren M, Strid H, Bajor A, Sadik R. Physical activity improves symptoms in irritable bowel syndrome: a randomized controlled trial. Am J Gastroenterol. 2011 May;106(5):915-22. doi: 10.1038/ajg.2010.480. Epub 2011 Jan 4.

  PMID: 21206488 BACKGROUND

• Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.

  PMID: 9146781 BACKGROUND

• Prospero L, Riezzo G, Linsalata M, Orlando A, D'Attoma B, Russo F. Psychological and Gastrointestinal Symptoms of Patients with Irritable Bowel Syndrome Undergoing a Low-FODMAP Diet: The Role of the Intestinal Barrier. Nutrients. 2021 Jul 19;13(7):2469. doi: 10.3390/nu13072469.

  PMID: 34371976 BACKGROUND

• Linsalata M, Riezzo G, Orlando A, D'Attoma B, Prospero L, Tutino V, Notarnicola M, Russo F. The Relationship between Low Serum Vitamin D Levels and Altered Intestinal Barrier Function in Patients with IBS Diarrhoea Undergoing a Long-Term Low-FODMAP Diet: Novel Observations from a Clinical Trial. Nutrients. 2021 Mar 21;13(3):1011. doi: 10.3390/nu13031011.

  PMID: 33801020 BACKGROUND

• Franco I, Bianco A, Diaz MDP, Bonfiglio C, Chiloiro M, Pou SA, Becaria Coquet J, Mirizzi A, Nitti A, Campanella A, Leone CM, Caruso MG, Correale M, Osella AR. Effectiveness of two physical activity programs on non-alcoholic fatty liver disease. a randomized controlled clinical trial. Rev Fac Cien Med Univ Nac Cordoba. 2019 Feb 27;76(1):26-36. doi: 10.31053/1853.0605.v76.n1.21638.

  PMID: 30882339 BACKGROUND

• Notarnicola M, Caruso MG, Tutino V, Bonfiglio C, Cozzolongo R, Giannuzzi V, De Nunzio V, De Leonardis G, Abbrescia DI, Franco I, Intini V, Mirizzi A, Osella AR. Significant decrease of saturation index in erythrocytes membrane from subjects with non-alcoholic fatty liver disease (NAFLD). Lipids Health Dis. 2017 Aug 23;16(1):160. doi: 10.1186/s12944-017-0552-0.

  PMID: 28830448 BACKGROUND

• Tutino V, De Nunzio V, Caruso MG, Bonfiglio C, Franco I, Mirizzi A, De Leonardis G, Cozzolongo R, Giannuzzi V, Giannelli G, Notarnicola M, Osella AR. Aerobic Physical Activity and a Low Glycemic Diet Reduce the AA/EPA Ratio in Red Blood Cell Membranes of Patients with NAFLD. Nutrients. 2018 Sep 13;10(9):1299. doi: 10.3390/nu10091299.

  PMID: 30217048 BACKGROUND

• Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.

  PMID: 3123181 BACKGROUND

• Riegler G, Esposito I. Bristol scale stool form. A still valid help in medical practice and clinical research. Tech Coloproctol. 2001 Dec;5(3):163-4. doi: 10.1007/s101510100019.

  PMID: 11875684 BACKGROUND

• Hanson S, Jones A. Is there evidence that walking groups have health benefits? A systematic review and meta-analysis. Br J Sports Med. 2015 Jun;49(11):710-5. doi: 10.1136/bjsports-2014-094157. Epub 2015 Jan 19.

  PMID: 25601182 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

• 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

• 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

• Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.

  PMID: 23851406 BACKGROUND

• Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.

  PMID: 22018588 BACKGROUND

• Pengpid S, Peltzer K. Sedentary Behaviour, Physical Activity and Life Satisfaction, Happiness and Perceived Health Status in University Students from 24 Countries. Int J Environ Res Public Health. 2019 Jun 13;16(12):2084. doi: 10.3390/ijerph16122084.

  PMID: 31200427 BACKGROUND

• Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. doi: 10.1037//0022-3514.69.4.719.

  PMID: 7473027 BACKGROUND

• Laukkanen R, Oja P, Pasanen M, Vuori I. Validity of a two kilometre walking test for estimating maximal aerobic power in overweight adults. Int J Obes Relat Metab Disord. 1992 Apr;16(4):263-8.

  PMID: 1318280 BACKGROUND

• Pearn J, Bullock K. A portable hand-grip dynamometer. Aust Paediatr J. 1979 Jun;15(2):107-9. doi: 10.1111/j.1440-1754.1979.tb01200.x. No abstract available.

  PMID: 485989 BACKGROUND

• Ulijaszek SJ, Kerr DA. Anthropometric measurement error and the assessment of nutritional status. Br J Nutr. 1999 Sep;82(3):165-77. doi: 10.1017/s0007114599001348.

  PMID: 10655963 BACKGROUND

• Hoeger WW, Hopkins DR. A comparison of the sit and reach and the modified sit and reach in the measurement of flexibility in women. Res Q Exerc Sport. 1992 Jun;63(2):191-5. doi: 10.1080/02701367.1992.10607580. No abstract available.

  PMID: 1585066 BACKGROUND

• Khalil SF, Mohktar MS, Ibrahim F. The theory and fundamentals of bioimpedance analysis in clinical status monitoring and diagnosis of diseases. Sensors (Basel). 2014 Jun 19;14(6):10895-928. doi: 10.3390/s140610895.

  PMID: 24949644 BACKGROUND

• Midenfjord I, Polster A, Sjovall H, Tornblom H, Simren M. Anxiety and depression in irritable bowel syndrome: Exploring the interaction with other symptoms and pathophysiology using multivariate analyses. Neurogastroenterol Motil. 2019 Aug;31(8):e13619. doi: 10.1111/nmo.13619. Epub 2019 May 5.

  PMID: 31056802 BACKGROUND

• Garner DM, Garfinkel PE. The Eating Attitudes Test: an index of the symptoms of anorexia nervosa. Psychol Med. 1979 May;9(2):273-9. doi: 10.1017/s0033291700030762.

  PMID: 472072 BACKGROUND

• Bertolotti G, Zotti AM, Michielin P, Vidotto G, Sanavio E. A computerized approach to cognitive behavioural assessment: an introduction to CBA-2.0 primary scales. J Behav Ther Exp Psychiatry. 1990 Mar;21(1):21-7. doi: 10.1016/0005-7916(90)90045-m.

  PMID: 2197296 BACKGROUND

• Zung WW. A rating instrument for anxiety disorders. Psychosomatics. 1971 Nov-Dec;12(6):371-9. doi: 10.1016/S0033-3182(71)71479-0. No abstract available.

  PMID: 5172928 BACKGROUND

• ZUNG WW. A SELF-RATING DEPRESSION SCALE. Arch Gen Psychiatry. 1965 Jan;12:63-70. doi: 10.1001/archpsyc.1965.01720310065008. No abstract available.

  PMID: 14221692 BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• The psychological results of 438 patients with persisting GERD symptoms by Symptom Checklist 90-Revised (SCL-90-R) questionnaire: Retraction. Medicine (Baltimore). 2018 Jun;97(22):e10768. doi: 10.1097/MD.0000000000010768. No abstract available.

  PMID: 29851782 BACKGROUND

• Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998 Feb;43(2):400-11. doi: 10.1023/a:1018831127942.

  PMID: 9512138 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

• Kataoka K. The intestinal microbiota and its role in human health and disease. J Med Invest. 2016;63(1-2):27-37. doi: 10.2152/jmi.63.27.

  PMID: 27040049 BACKGROUND

• Garcia Regueiro JA, Rius MA. Rapid determination of skatole and indole in pig back fat by normal-phase liquid chromatography. J Chromatogr A. 1998 Jun 5;809(1-2):246-51. doi: 10.1016/s0021-9673(98)00191-5.

  PMID: 9677718 BACKGROUND

• Simren M, Tack J. New treatments and therapeutic targets for IBS and other functional bowel disorders. Nat Rev Gastroenterol Hepatol. 2018 Oct;15(10):589-605. doi: 10.1038/s41575-018-0034-5.

  PMID: 29930260 RESULT

• Prospero L, Riezzo G, D'Attoma B, Ignazzi A, Bianco A, Franco I, Curci R, Campanella A, Bagnato CB, Porcelli P, Giannelli G, Russo F. The impact of locus of control on somatic and psychological profiles of patients with irritable bowel syndrome engaging in aerobic exercise. Sci Rep. 2025 Feb 1;15(1):3966. doi: 10.1038/s41598-025-88466-7.

  PMID: 39893252 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

• Alberto R Osella, PhD

  National Institute for Digestive Diseases IRCCS " Saverio de Bellis"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: July 12, 2022
• Study Start: May 2, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 30, 2024
• Last Updated: May 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)