Cardiovascular exercise for improving symptoms in IBS patients with a sedentary lifestyle

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

This study is testing if regular cardiovascular exercise can help people with irritable bowel syndrome who don't get much physical activity feel better and improve their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Universitair Ziekenhuis Brussel (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Jette)
• Trial ID: NCT05680766 on ClinicalTrials.gov

What this trial studies

This exploratory study aims to assess the impact of cardiovascular endurance training (CET) on the severity of symptoms in patients with irritable bowel syndrome (IBS) who lead a sedentary lifestyle. The study will evaluate changes in IBS symptom severity and explore underlying mechanisms such as dietary adaptations, mental well-being, and alterations in the gut microbiome. By focusing on a small group of patients, the study seeks to gather preliminary data on how regular physical activity may influence IBS symptoms and related factors. The findings could provide insights into lifestyle modifications as a management option for IBS.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 who meet the ROME IV criteria for IBS and have a sedentary lifestyle.

Not a fit: Patients with cardiorespiratory disorders, active psychiatric conditions, or other significant gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new non-pharmacological approach to alleviate symptoms of IBS through physical activity.

How similar studies have performed: While research on physical activity's role in IBS is limited, similar studies exploring lifestyle modifications have shown promising results.

Eligibility criteria

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.

Where this trial is running

Jette

• UZ Brussel — Jette, Belgium (Recruiting)

Study contacts

• Study coordinator: Sébastien Kindt

Conditions Irritable Bowel Syndrome