Feasibility Assessment of Cardiovascular Endurance Training for the Symptomatic Improvement of Irritable Bowel Syndrome Patients With a Sedentary and Non-active Lifestyle.

This exploratory study's primary objective is the changes of irritable bowel syndrome (IBS) symptom severity by cardiovascular endurance training (CET) in relation to the baseline sedentary or non-active lifestyle. Secondary endpoints focus on the mechanisms associated with these changes.

These mechanisms relate to dietary adaptations, changes in anxiety, depressive comorbidity, somatisation, alterations in the gut microbiome or metabolome, body composition and measures of cardiovascular fitness. Virtually all IBS guidelines mention lifestyle modifications as a management option.

Research on the role of physical activity remains underassessed as compared to the other interventions. Therefore, an exploratory proof-of-concept study will investigate the influence of regular physical exercise on symptoms in a small group of IBS patients. This study will gather data on putative underlying mechanisms related to dietary factors, faecal microbiome and metabolome, mental well-being, body composition and cardiovascular fitness.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: Cardiovascular endurance training

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sébastien Kindt; Phone Number: 60 11 +32 2 477; Email: sebastien.kindt@uzbrussel.be
• Study Contact Backup: Name: Virgini Van Buggenhout; Phone Number: 50 14 +32 2 477; Email: virgini.vanbuggenhout@uzbrussel.be

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Sebastien Kindt; Phone Number: 60 11 +32 2 477

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 - 60 years;
• Fulfilling the ROME IV criteria for Irritable bowel syndrome (IBS);
• Moderate symptom severity as defined by a IBS-Symptom Severity Scale > 175;
• Sedentary lifestyle defined as SIT-Q-7D > 8h/day;
• Physically inactive defined as < 150min/week on the IPAQ score

Exclusion Criteria:

• Cardiorespiratory disorder hampering participation in a program of physical exercise as evidenced by the sport + keuringsartsen (SKA) questionnaire.
• Clinical suspicion of an organic disorder different from IBS (patients can be included when this disorder had been excluded);
• Known inflammatory bowel disorder;
• Known intestinal motility disorder;
• Alcohol (defined as more than 14 U per week) or other substance abuse;
• Active psychiatric disorder;
• Known systemic or auto-immune disorder with implication for the GI system;
• Prior abdominal surgery (with the exception of appendectomy or cholecystectomy more than 6 months ago);
• Any prior diagnosis of cancer other than basocellular carcinoma;
• Current chemotherapy;
• History of gastro-enteritis in the past 8 weeks;
• Change in diet in the past 8 weeks;
• Dietary supplements unless taken at a stable dose for more than 8 weeks;
• Antibiotics, pre-, pro-, post-biotics or any combination during the past 8 weeks;
• Treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 12 weeks is allowed);
• Treatment with spasmolytic agents, opioids, loperamide, gelatine tannate or mucoprotect-ants during the past 8 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; IBS subjects fulfilling the eligibility criteria will follow a structured and personalised cardiovascular endurance training (CET).	Other: Cardiovascular endurance training; Based on the results of a maximal effort test, investigators will provide a personalised training program. Results of a submaximal effort test after 6 weeks, will allow for adaptation of the training program for the remaining training period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of IBS Symptom severity	this will be assessed after patients have done a cardiovascular endurance training	from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of IBS Symptom severity	this will be assessed after patients have done a cardiovascular endurance training	from baseline to 6 weeks

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): January 2, 2030
• Study Completion (Estimated): January 2, 2030

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: Face-IT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No