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

Study Overview
=================
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.

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

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Behavioral: Exercise intervention
* Behavioral: Lifestyle - online lesson intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will apply a superior trial design in this randomized clinical trial with two arms, intervention, and comparison.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health - Waist circumference | Waist circumference | 12 weeks | 
| General health - blood pressure | Blood pressure | 12 weeks | 
| General health - Lipid | 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 | Harvey Bradshaw Index (Crohn's disease) Simple Clinical Colitis Activity Index (Ulcerative colitis) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise