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

Primary Purpose

Irritable Bowel Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiovascular endurance training
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention arm

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Change of IBS Symptom severity
    this will be assessed after patients have done a cardiovascular endurance training

    Secondary Outcome Measures

    Change of IBS Symptom severity
    this will be assessed after patients have done a cardiovascular endurance training

    Full Information

    First Posted
    December 23, 2022
    Last Updated
    February 22, 2023
    Sponsor
    Universitair Ziekenhuis Brussel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05680766
    Brief Title
    Feasibility Assessment of Cardiovascular Endurance Training for the Symptomatic Improvement of Irritable Bowel Syndrome Patients With a Sedentary and Non-active Lifestyle.
    Official Title
    Feasibility Assessment of Cardiovascular Endurance Training for the Symptomatic Improvement of Irritable Bowel Syndrome Patients With a Sedentary and Non-active Lifestyle.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2, 2023 (Anticipated)
    Primary Completion Date
    January 2, 2026 (Anticipated)
    Study Completion Date
    January 2, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitair Ziekenhuis Brussel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    IBS subjects fulfilling the eligibility criteria will follow a structured and personalised cardiovascular endurance training (CET).
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention arm
    Arm Type
    Experimental
    Arm Description
    IBS subjects fulfilling the eligibility criteria will follow a structured and personalised cardiovascular endurance training (CET).
    Intervention Type
    Other
    Intervention Name(s)
    Cardiovascular endurance training
    Intervention Description
    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 Measure Information:
    Title
    Change of IBS Symptom severity
    Description
    this will be assessed after patients have done a cardiovascular endurance training
    Time Frame
    from baseline to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change of IBS Symptom severity
    Description
    this will be assessed after patients have done a cardiovascular endurance training
    Time Frame
    from baseline to 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sébastien Kindt
    Phone
    +32 2 477
    Ext
    60 11
    Email
    sebastien.kindt@uzbrussel.be
    First Name & Middle Initial & Last Name or Official Title & Degree
    Virgini Van Buggenhout
    Phone
    +32 2 477
    Ext
    50 14
    Email
    virgini.vanbuggenhout@uzbrussel.be

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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