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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversitair Ziekenhuis Brussel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Cardiovascular endurance training

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change of IBS Symptom severity

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

Time frame
from baseline to 12 weeks

Secondary outcomes

1

Change of IBS Symptom severity

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

Time frame
from baseline to 6 weeks

Other outcomes

Sponsors and contacts

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