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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT04816812
Eligibility Criteria:
Inclusion Criteria:
* Patients with moderately active Crohn's disease or ulcerative colitis are defined by fulfilling all the following five criteria:
1. Well-characterized Crohn's disease or ulcerative colitis (physician assessment) i. Fulfilling standard clinical, endoscopic, radiologic, and histological criteria
2. A minimum of one-year disease duration from the time of diagnosis of Crohn's disease or ulcerative colitis to inclusion into the trial
3. Any of the following pharmacological treatments in a period of three months prior to inclusion:
i. Usage of 5-Aminosalicylic acid (5-ASA) ii. Usage of corticosteroids iii. Immunomodulators usage: Azathioprine (AZA), 6-mercaptopurine (6-MP), Methotrexate (MTX) iv. Biologics usage: Anti-TNFα (Infliximab, Adalimumab, Golimumab), Ustekinumab or Anti-integrin (Vedolizumab)
4. Disease activity defined by clinical disease score:
i. Harvey Bradshaw Index (HBI) 27 \> 5 ii. Simple Clinical Colitis Activity Index (SCCAI) 29 \> 5
5. Marker for gastrointestinal inflammation:
i. Fecal calprotectin (FC) \> 200 mg/g
Exclusion Criteria:
* 1\. A language barrier that prohibits the exercise instructors/supervisors to give sufficient or safe instructions during the intervention or at the general health lesson.
2\. Known heart condition that prevents them to actively participate safely in the exercise intervention.
3\. Known pregnancy or planned pregnancy. 4. Disabling musculoskeletal injuries that prevent them to actively participate in the exercise intervention.
5\. Severe disease activity manifested clinically and with the need for urgent change in treatment evaluated by the responsible physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04816812
Study Brief:
Protocol Section:
NCT04816812