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NCT Number: NCT05680766

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Jette, 1090, Belgium

Location status: Recruiting

Location contact

Sebastien Kindt

CONTACT

+32 2 477 ext. 60 11

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change of IBS Symptom severity

    Time frame: from baseline to 12 weeks

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

Secondary outcomes

  1. Change of IBS Symptom severity

    Time frame: from baseline to 6 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sébastien Kindt

CONTACT

[email protected]

+32 2 477 ext. 60 11

Virgini Van Buggenhout

CONTACT

[email protected]

+32 2 477 ext. 50 14

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jan 11, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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