Status:
COMPLETED
The IBD-FITT Study - Moderate-intensity Exercise for IBD Patients With Moderate Disease Activity
Lead Sponsor:
University of Southern Denmark
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators aim to investigate whether exercise therapy during 12 weeks including a lesson on general healthy lifestyle in adult patients with a moderately active disease is more effective, comp...
Detailed Description
The investigators will apply a superior trial design in this randomized clinical trial with two arms, intervention and comparison. In both the intervention and comparison arm, the patients will receiv...
Eligibility Criteria
Inclusion
- Patients with moderately active Crohn's disease or ulcerative colitis are defined by fulfilling all the following five criteria:
- Well-characterized Crohn's disease or ulcerative colitis (physician assessment) i. Fulfilling standard clinical, endoscopic, radiologic, and histological criteria
- A minimum of one-year disease duration from the time of diagnosis of Crohn's disease or ulcerative colitis to inclusion into the trial
- 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)
- Disease activity defined by clinical disease score:
- i. Harvey Bradshaw Index (HBI) 27 \> 5 ii. Simple Clinical Colitis Activity Index (SCCAI) 29 \> 5
- Marker for gastrointestinal inflammation:
- i. Fecal calprotectin (FC) \> 200 mg/g
Exclusion
- 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.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04816812
Start Date
November 15 2021
End Date
May 31 2023
Last Update
December 4 2023
Active Locations (2)
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1
Hospital of Southwest Jutland
Esbjerg, Denmark
2
Odense University Hospital
Odense, Denmark