Clinical trial NCT04816812: The IBD-FITT Study - Moderate-intensity Exercise for IBD Patients With Moderate Disease Activity
Official title: The IBD-FITT Study - Moderate-intensity Exercise for Patients With Inflammatory Bowel Disease With Moderate Disease Activity: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Exercise
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will apply a superior trial design in this randomized clinical trial with two arms, intervention, and comparison.
Primary purpose: TREATMENT

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, compared to control patients only receiving a lesson on general healthy lifestyle recommendations. The three main categories of outcomes are 1) health-related quality of life, 2) general health status of the patients 3) explorative outcomes. The primary outcome is health-related quality of life, the secondary outcome is general health status measured by waist circumference, disease activity scores, blood pressure, and blood lipids, and the third outcome are explorative outcomes (none-disease specific quality of life scores, biomarkers of C-reactive protein, fecal calprotectin and immunology markers including interleukins).

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 receive the proper and usual medical treatment decided by their responsible physician and changes in the medical treatment is allowed at all times.

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.

Primary outcomes:
measure: Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: 12 weeks
Secondary outcomes:
measure: General health - Waist circumference
timeFrame: 12 weeks
measure: General health - blood pressure
timeFrame: 12 weeks
measure: General health - Lipid
timeFrame: 12 weeks
measure: General health - Clinical disease activity
timeFrame: 12 weeks
Other outcomes:
measure: Explorative - European Quality of life
timeFrame: 12 weeks
measure: Explorative - Biomarkers
timeFrame: 12 weeks
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of Southwest Jutland
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital & University of Southern Denmark
name: Ken Lund, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elia J, Kane S. Adult Inflammatory Bowel Disease, Physical Rehabilitation, and Structured Exercise. Inflamm Bowel Dis. 2018 Nov 29;24(12):2543-2549. doi: 10.1093/ibd/izy199.
citation: Shephard RJ. The Case for Increased Physical Activity in Chronic Inflammatory Bowel Disease: A Brief Review. Int J Sports Med. 2016 Jun;37(7):505-15. doi: 10.1055/s-0042-103157. Epub 2016 Apr 26.
citation: Eckert KG, Abbasi-Neureither I, Koppel M, Huber G. Structured physical activity interventions as a complementary therapy for patients with inflammatory bowel disease - a scoping review and practical implications. BMC Gastroenterol. 2019 Jul 2;19(1):115. doi: 10.1186/s12876-019-1034-9.
citation: Bilski J, Mazur-Bialy A, Brzozowski B, Magierowski M, Zahradnik-Bilska J, Wojcik D, Magierowska K, Kwiecien S, Mach T, Brzozowski T. Can exercise affect the course of inflammatory bowel disease? Experimental and clinical evidence. Pharmacol Rep. 2016 Aug;68(4):827-36. doi: 10.1016/j.pharep.2016.04.009. Epub 2016 May 2.
citation: Reed JL, Pipe AL. Practical Approaches to Prescribing Physical Activity and Monitoring Exercise Intensity. Can J Cardiol. 2016 Apr;32(4):514-22. doi: 10.1016/j.cjca.2015.12.024. Epub 2015 Dec 29.
citation: Bandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017 Oct;51(20):1494-1501. doi: 10.1136/bjsports-2017-097527. Epub 2017 Sep 7. No abstract available.