The IBD-FITT Study - Moderate-intensity Exercise for IBD Patients With Moderate Disease Activity

NCT04816812 | Completed DMC

• 1 other identifier: IBD-FITT_1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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).

Conditions

Inflammatory Bowel Diseases

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• Inflammatory Bowel Disease Questionnaire (IBDQ)

  Health-related quality of life

  12 weeks

Secondary Outcomes (4)

• General health - Waist circumference

  12 weeks

• General health - blood pressure

  12 weeks

• General health - Lipid

  12 weeks

• General health - Clinical disease activity

  12 weeks

Other Outcomes (2)

• Explorative - European Quality of life

  12 weeks

• Explorative - Biomarkers

  12 weeks

Study Arms (2)

Exercise

OTHER

In the intervention arm, a 12-week aerobic exercise program tailored to the individual patients by physiotherapists using the principles of Frequency, Intensity, Time, and, Type (FITT) aiming to increase or maintain the physical activity level to a weekly moderate activity level.

Behavioral: Exercise intervention; Behavioral: Lifestyle - online lesson intervention

Comparison

OTHER

Comparison

Behavioral: Lifestyle - online lesson intervention

Interventions

Exercise intervention BEHAVIORAL

A 12-week aerobic exercise program tailored to the individual patients by physiotherapists using the principles of Frequency, Intensity, Time, and, Type (FITT) aiming to increase or maintain the physical activity level to a weekly moderate activity level. This includes two supervised exercise sessions of 60 minutes per week, combined with one weekly home training session. The type of exercise is planned by a physiotherapist to fit each patient during sessions. We monitor the intervention by training diaries including frequency, intensity, time, and type of exercise (FITT) and the verbal BORG 15-point scale and heart rate monitors. We will also monitor the overall seven days' physical activity level by accelerometry using the AX3 device from the company Axivity at weeks 0 and 12.

Exercise

Lifestyle - online lesson intervention BEHAVIORAL

The investigators offer one online lesson of 15-25 minutes on lifestyle guidance including general advice on healthy living.

Comparison; Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• \. A language barrier that prohibits the exercise instructors/supervisors to give sufficient or safe instructions during the intervention or at the general health lesson.
• \. Known heart condition that prevents them to actively participate safely in the exercise intervention.
• \. Known pregnancy or planned pregnancy. 4. Disabling musculoskeletal injuries that prevent them to actively participate in the exercise intervention.
• \. Severe disease activity manifested clinically and with the need for urgent change in treatment evaluated by the responsible physician.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (2)

Hospital of Southwest Jutland

Esbjerg, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Related Publications (7)

• 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.

  PMID: 29850914 BACKGROUND

• 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.

  PMID: 27116344 BACKGROUND

• 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.

  PMID: 31266461 BACKGROUND

• 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.

  PMID: 27255494 BACKGROUND

• 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.

  PMID: 26897182 BACKGROUND

• 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.

  PMID: 28882839 BACKGROUND

• Lund K, Knudsen T, Kjeldsen J, Nielsen RG, Juhl CB, Norgard BM. The IBD-FITT study - moderate-intensity exercise for patients with inflammatory bowel disease with moderate disease activity: an open-label randomized controlled trial. Trials. 2023 Nov 20;24(1):742. doi: 10.1186/s13063-023-07781-4.

  PMID: 37986021 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior

Study Officials

• Ken Lund, PhD

  Odense University Hospital & University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The investigators will apply a superior trial design in this randomized clinical trial with two arms, intervention, and comparison.

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 25, 2021
• Study Start: November 15, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)