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

December 1, 2023 updated by: Ken Lund, University of Southern Denmark

The IBD-FITT Study - Moderate-intensity Exercise for Patients With Inflammatory Bowel Disease With Moderate Disease Activity: a Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark
        • Hospital of Southwest Jutland
      • Odense, Denmark
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Exercise
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
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.
Behavioral: Lifestyle - online lesson intervention
The investigators offer one online lesson of 15-25 minutes on lifestyle guidance including general advice on healthy living.
Other: Comparison
Behavioral: Lifestyle - online lesson intervention
The investigators offer one online lesson of 15-25 minutes on lifestyle guidance including general advice on healthy living.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: 12 weeks
Health-related quality of life
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General health - Waist circumference
Time Frame: 12 weeks
Waist circumference
12 weeks
General health - blood pressure
Time Frame: 12 weeks
Blood pressure
12 weeks
General health - Lipid
Time Frame: 12 weeks

Lipid status:

i. Low-density lipoprotein (LDL) ii. High-density lipoprotein (HDL) iii. Triglycerides iv. Total cholesterol v. Hemoglobin A (Hbac1)
12 weeks
General health - Clinical disease activity
Time Frame: 12 weeks
Harvey Bradshaw Index (Crohn's disease) Simple Clinical Colitis Activity Index (Ulcerative colitis)
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explorative - European Quality of life
Time Frame: 12 weeks
European Quality of life (EQ5D)
12 weeks
Explorative - Biomarkers
Time Frame: 12 weeks
i. Fecal calprotectin ii. C-reactive protein iii. Immunology (cytokines)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • Principal Investigator: Ken Lund, PhD, Odense University Hospital & University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBD-FITT_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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