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

NCT05680766 | Recruiting

• 1 other identifier: Face-IT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change of IBS Symptom severity

  this will be assessed after patients have done a cardiovascular endurance training

  from baseline to 12 weeks

Secondary Outcomes (1)

• Change of IBS Symptom severity

  from baseline to 6 weeks

Study Arms (1)

Intervention arm

EXPERIMENTAL

IBS subjects fulfilling the eligibility criteria will follow a structured and personalised cardiovascular endurance training (CET).

Other: Cardiovascular endurance training

Interventions

Cardiovascular endurance training OTHER

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Sébastien Kindt

CONTACT

+32 2 477; sebastien.kindt@uzbrussel.be

Virgini Van Buggenhout

CONTACT

+32 2 477; virgini.vanbuggenhout@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: IBS subjects fulfilling the eligibility criteria will follow a structured and personalised cardiovascular endurance training (CET).

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 11, 2023
• Study Start: October 16, 2023
• Primary Completion (Estimated): January 2, 2030
• Study Completion (Estimated): January 2, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

BE (1)