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Recruiting NCT05680766

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

No phase Interventional Irritable Bowel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardiovascular endurance training.
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change of IBS Symptom severity [Time frame: from baseline to 12 weeks]
Secondary outcome measures (1)
  • Change of IBS Symptom severity [Time frame: from baseline to 6 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • UZ Brussel — Jette

Identifiers

NCT: NCT05680766 · Face-IT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗