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Inflammatory Bowel DiseasesIBD-FITTNCT04816812

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

A study testing Exercise intervention and Lifestyle - online lesson intervention in people with Inflammatory Bowel Diseases, run by University of Southern Denmark at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Inflammatory Bowel Diseases
What is being tested?
Exercise intervention and Lifestyle - online lesson intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesDenmark
Study dates
15 Nov 2021to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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:
Show all 9Show fewer
  • Harvey Bradshaw Index (HBI) 27 > 5 ii. Simple Clinical Colitis Activity Index (SCCAI) 29 > 5
  • Marker for gastrointestinal inflammation:
  • Fecal calprotectin (FC) > 200 mg/g

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Hospital of Southwest Jutland

    Esbjerg

  • Odense University Hospital

    Odense

Other trials in Denmark

About this study

Official title: 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).

Read the 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.

Being tested
Exercise intervention, Lifestyle - online lesson intervention
Keywords
Exercise
Medical subject headings
Inflammatory Bowel Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise interventionBehavioural

    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.

  • Lifestyle - online lesson interventionBehavioural

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

Study groups in NCT04816812
Study groupRoleWhat they receive
ExerciseOtherIn 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.
Receives: Behavioral: Exercise intervention; Behavioral: Lifestyle - online lesson intervention
ComparisonOtherComparison
Receives: Behavioral: Lifestyle - online lesson intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammatory Bowel Disease Questionnaire (IBDQ)

    Health-related quality of life

    Measured: 12 weeks

Secondary outcomes (4)

  1. General health - Waist circumference

    Waist circumference

    Measured: 12 weeks

  2. General health - blood pressure

    Blood pressure

    Measured: 12 weeks

  3. General health - Lipid

    Lipid status:

    1. Low-density lipoprotein (LDL) ii. High-density lipoprotein (HDL) iii. Triglycerides iv. Total cholesterol v. Hemoglobin A (Hbac1)

    Measured: 12 weeks

  4. General health - Clinical disease activity

    Harvey Bradshaw Index (Crohn's disease) Simple Clinical Colitis Activity Index (Ulcerative colitis)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2021
  2. Study start15 Nov 2021
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04816812
Sponsor's protocol ID
IBD-FITT_1
Acronym
IBD-FITT
Status last verified
Dec 2023
First submitted
19 Mar 2021
Last updated
4 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29850914

  • 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.

    PubMed 27116344

  • 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.

    PubMed 31266461

  • 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.

    PubMed 27255494

  • 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.

    PubMed 26897182

  • 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.

    PubMed 28882839

  • 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.

    PubMed 37986021

Questions about this trial

What is this clinical trial studying?

A study testing Exercise intervention and Lifestyle - online lesson intervention in people with Inflammatory Bowel Diseases, run by University of Southern Denmark at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammatory Bowel Disease Questionnaire (IBDQ) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04816812, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.

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