Inflammatory Bowel DiseaseMICINCT02861053
Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?
A study testing regular and moderate physical activity and No regular and moderate physical activity more than usual in people with Inflammatory Bowel Disease, run by University Hospital, Rouen at 1 site in France.
Trial summary
The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The beneficial role of a regular physical activity on the quality of life of patients having an IBD was demonstrated in 5 studies including only 1… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- regular and moderate physical activity and No regular and moderate physical activity more than usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2018to 4 Mar 2020
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients ≥ 18 years old
- Patients suffering from IBD
- Patients with a FACIT score < 30
- Patients with BD in remission with a C-reactiv protein dose < 5
- Patients with Hemoglobin dosage > 10g/dl
- Patients with 18<BMI<30 kg/m2
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- Informed consent given by the patients
- Patients affiliated to the social security
- Patients living not far from the centre where the rehabilitation program will be performed
- Women with no risk of pregnancy (menopausal women or with contraceptive drugs).
Who cannot join
- Patients ≥ 45 years old
- Inability to walk or to ride a bike
- Contraindication to practice physical exercise
- Contraindication to exercise test
- Participation to another research study within the week preceding the beginning of the protocol
- Patients unstable smokers
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- Patients unable to keep their medical treatment stable along the study
- Patients with a regular intensive physical practice
- Patients with depression (HAD>11/21)
- Patients with bad sleep quality (PSQI score >5)
- Pregnant or breast-feeding patients
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The beneficial role of a regular physical activity on the quality of life of patients having an IBD was demonstrated in 5 studies including only 1 controlled one [Bilski, on 2013]. The mechanism by which the physical activity could improve the quality of life of the patients remains unknown (stress decreased, reduction of the inflammatory process) [Bilski, on 2014]. Several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated the beneficial effect of a regular physical exercise to reduce the fatigue of patients. It was recently demonstrated that the chronic fatigue observed in patients with IBD came along with a physical reduction in the performances during the exercise test and a reduction in the physical activity of the patients [Vogelaar, 2015].
Our hypothesis is that a regular moderate physical activity could improve physical performance during an effort et could reduce the chronic fatigue and improve their quality of life.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- regular and moderate physical activity, No regular and moderate physical activity more than usual
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular and moderate physical activityOther
regular and moderate physical activity will be done 3 times per week more than usual
No regular and moderate physical activity more than usualOther
regular and moderate physical activity will be done as usual
| Study group | Role | What they receive |
|---|---|---|
| chronic quiet inflammatory bowel disease patient (IBD) | Experimental | Patient with chronic quiet inflammatory bowel disease patient (IBD) with regular and moderate physical activity Receives: Other: regular and moderate physical activity; Other: No regular and moderate physical activity more than usual |
| chronic quiet inflammatory bowel disease Patient (IBD) | Sham comparator | Patient with chronic quiet inflammatory bowel disease patient (IBD) with no regular and moderate physical activity more than usual Receives: Other: regular and moderate physical activity; Other: No regular and moderate physical activity more than usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from baseline in the evaluation of fatigue
Evaluation of fatigue using FACIT questionnaire
Measured: 3 Month
Secondary outcomes (2)
Difference from baseline in the Evaluation of the Quality of life
Evaluation of the Quality of life using Quality of life scores (IBDQ)
Measured: 3 Month
Difference from baseline in the Evaluation of the Quality of life
Evaluation of the Quality of life using Quality of life scores (SF36)
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start11 Sep 2018
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Why it stopped: Difficulty in enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David DEBEAUMONT, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861053
- Sponsor's protocol ID
- 2016/013/HP
- Acronym
- MICI
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2016
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?
- ClinicalTrials.gov ID
- NCT02861053
- Acronym / sponsor ID
- MICI / 2016/013/HP
- Conditions
- Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The beneficial role of a regular physical activity on the quality of life of patients having an IBD was demonstrated in 5 studies including only 1 controlled one [Bilski, on 2013]. The mechanism by which the physical activity could improve the quality of life of the patients remains unknown (stress decreased, reduction of the inflammatory process) [Bilski, on 2014]. Several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated the beneficial effect of a regular physical exercise to reduce the fatigue of patients. It was recently demonstrated that the chronic fatigue observed in patients with IBD came along with a physical reduction in the performances during the exercise test and a reduction in the physical activity of the patients [Vogelaar, 2015].
Our hypothesis is that a regular moderate physical activity could improve physical performance during an effort et could reduce the chronic fatigue and improve their quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic quiet inflammatory bowel disease patient (IBD) | Experimental | Other: regular and moderate physical activity, Other: No regular and moderate physical activity more than usualPatient with chronic quiet inflammatory bowel disease patient (IBD) with regular and moderate physical activity |
| chronic quiet inflammatory bowel disease Patient (IBD) | Sham comparator | Other: regular and moderate physical activity, Other: No regular and moderate physical activity more than usualPatient with chronic quiet inflammatory bowel disease patient (IBD) with no regular and moderate physical activity more than usual |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients ≥ 18 years old
- Patients suffering from IBD
- Patients with a FACIT score < 30
- Patients with BD in remission with a C-reactiv protein dose < 5
- Patients with Hemoglobin dosage > 10g/dl
Key exclusion criteria (12 listed)
- Patients ≥ 45 years old
- Inability to walk or to ride a bike
- Contraindication to practice physical exercise
- Contraindication to exercise test
- Participation to another research study within the week preceding the beginning of the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regular and moderate physical activityregular and moderate physical activity will be done 3 times per week more than usual | Other | chronic quiet inflammatory bowel disease Patient (IBD), chronic quiet inflammatory bowel disease patient (IBD) |
| No regular and moderate physical activity more than usualregular and moderate physical activity will be done as usual | Other | chronic quiet inflammatory bowel disease Patient (IBD), chronic quiet inflammatory bowel disease patient (IBD) |
Primary outcome
Difference from baseline in the evaluation of fatigue
Time frame: 3 Month
Evaluation of fatigue using FACIT questionnaire
2 secondary outcomes
Difference from baseline in the Evaluation of the Quality of life
Time frame: 3 Month
Difference from baseline in the Evaluation of the Quality of life
Time frame: 3 Month
Results and safety
The study was stopped early (reason given: Difficulty in enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David DEBEAUMONT, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regular and moderate physical activity and No regular and moderate physical activity more than usual in people with Inflammatory Bowel Disease, run by University Hospital, Rouen at 1 site in France.
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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Difficulty in enrolling patients). Results are not available in the source record.
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?
Difference from baseline in the evaluation of fatigue (time frame: 3 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.