Back to resultsThe IBD-FITT Study - Moderate-intensity Exercise for IBD Patients With Moderate Disease Activity (IBD-FITT)
Primary Purpose
Inflammatory Bowel Diseases
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise intervention
Lifestyle - online lesson intervention
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Exercise
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.
Sites / Locations
- Hospital of Southwest Jutland
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Exercise
Comparison
Arm Description
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.
Comparison
Outcomes
Primary Outcome Measures
Inflammatory Bowel Disease Questionnaire (IBDQ)
Health-related quality of life
Secondary Outcome Measures
General health - Waist circumference
Waist circumference
General health - blood pressure
Blood pressure
General health - Lipid
Lipid status:
i. Low-density lipoprotein (LDL) ii. High-density lipoprotein (HDL) iii. Triglycerides iv. Total cholesterol v. Hemoglobin A (Hbac1)
General health - Clinical disease activity
Harvey Bradshaw Index (Crohn's disease) Simple Clinical Colitis Activity Index (Ulcerative colitis)
Full Information
NCT ID
NCT04816812
First Posted
March 19, 2021
Last Updated
May 8, 2023
Sponsor
University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04816812
Brief Title
The IBD-FITT Study - Moderate-intensity Exercise for IBD Patients With Moderate Disease Activity
Acronym
IBD-FITT
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Other
Arm Description
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.
Arm Title
Comparison
Arm Type
Other
Arm Description
Comparison
Intervention Type
Behavioral
Intervention Name(s)
Exercise intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle - online lesson intervention
Intervention Description
The investigators offer one online lesson of 15-25 minutes on lifestyle guidance including general advice on healthy living.
Primary Outcome Measure Information:
Title
Inflammatory Bowel Disease Questionnaire (IBDQ)
Description
Health-related quality of life
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
General health - Waist circumference
Description
Waist circumference
Time Frame
12 weeks
Title
General health - blood pressure
Description
Blood pressure
Time Frame
12 weeks
Title
General health - Lipid
Description
Lipid status:
i. Low-density lipoprotein (LDL) ii. High-density lipoprotein (HDL) iii. Triglycerides iv. Total cholesterol v. Hemoglobin A (Hbac1)
Time Frame
12 weeks
Title
General health - Clinical disease activity
Description
Harvey Bradshaw Index (Crohn's disease) Simple Clinical Colitis Activity Index (Ulcerative colitis)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Explorative - European Quality of life
Description
European Quality of life (EQ5D)
Time Frame
12 weeks
Title
Explorative - Biomarkers
Description
i. Fecal calprotectin ii. C-reactive protein iii. Immunology (cytokines)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Lund, PhD
Organizational Affiliation
Odense University Hospital & University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Southwest Jutland
City
Esbjerg
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29850914
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.
Results Reference
background
PubMed Identifier
27116344
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.
Results Reference
background
PubMed Identifier
31266461
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.
Results Reference
background
PubMed Identifier
27255494
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.
Results Reference
background
PubMed Identifier
26897182
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.
Results Reference
background
PubMed Identifier
28882839
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.
Results Reference
background
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The IBD-FITT Study - Moderate-intensity Exercise for IBD Patients With Moderate Disease Activity
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