Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT05482932
Eligibility Criteria:
Inclusion criteria for all participants:
* Any gender aged 18 years or older;
* American Society of Anesthesiologists (ASA) Physical Status I or II (i.e., normal healthy patient or a patient with mild systemic disease)
* No contraindications for exercise testing based on the PAR-Q
* Being able to provide written informed consent;
* Willing and able to complete questionnaires and perform performance tests;
* Being able to understand written Dutch and speak the Dutch language.
Inclusion criteria specific for patients with IBD:
* Certified diagnosis of IBD (UC or CD) based on the combination of endoscopic, radiological, and/or histological findings;
* No active disease or experiencing mild to moderate disease activity.
* Included in eHealth clinical care-pathway using myIBDcoach.
Inclusion criteria specific for healthy volunteers:
• No certified diagnosis of IBD (CD, UC, IBD-Unclassified);
Exclusion criteria for all participants:
* ASA Physical Status \> II (i.e., patient with severe systemic disease);
* Contraindications for exercise testing based on PAR-Q
* Other (temporary) injuries or severe (neuro)muscular, rheumatic, or orthopedic conditions that may interfere with study evaluations;
* Current malignancy (except for local cutaneous skin cancer) or successfully treated for a malignancy in the past 6 months;
* Pregnant or lactating women;
* Competitive and elite athletes (i.e., ≥6 hours/week of moderate to vigorous exercise)
* Not being able to understand or speak the Dutch language;
* Not being able to cooperate with test procedures or unable to provide informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05482932
Study Brief:
Protocol Section:
NCT05482932