Exercise as a potential remedy for IBD-related fatigue
NCT ID NCT07804511
First seen Sep 04, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This trial tests whether a personalized 6-month exercise program can reduce persistent fatigue in people with inflammatory bowel disease (IBD) who are in remission. Researchers will randomly assign 120 participants to either the exercise program or usual care. Fatigue levels are measured at 6 months using a standard questionnaire. The goal is to see if regular, adapted physical activity can improve daily energy and well-being.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A 6-month adapted physical activity program with 12 biweekly sessions and telephone follow-up
- What this could lead to
- If it works, this could offer a drug-free way to reduce persistent fatigue and improve quality of life for people with IBD in remission.
- What could go wrong
- The trial is relatively small and early, so results may not apply to everyone. Fatigue is subjective, and the exercise program may not outperform usual care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2027
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with inflammatory bowel disease (IBD) in clinical and biological remission (CRP/fecal calprotectin) for more than 6 months: * Remission according to PRO2 (Patient-Reported Outcome): liquid stool frequency ≤2/day and abdominal pain score ≤1 for Crohn's disease; stool frequency score ≤1 and rectal bleeding score = 0 for ulcerative colitis. * CRP \<5 mg/L. * Fecal calprotectin \<250 µg/g. 2. Patients with significant fatigue (FACIT-F score ≤40) persisting for at least 3 months before inclusion, confirmed by two successive FACIT-F questionnaire assessments: the first at the screening visit (M-3), after obtaining informed consent, serving as the baseline value, and the second at the inclusion visit (M0), confirming persistence of fatigue for at least 3 months. 3. Adults aged 18 years or older. 4. Medical certificate confirming fitness to participate in physical activity. If the participant does not have a recent certificate dated within the previous 3 months, a specific consultation with the treating physician will be required. This consultation will be covered by the sponsor. Exclusion Criteria: 1. Another identified cause of fatigue based on the first-line assessment performed in this context (complete blood count, liver function tests, CRP, blood electrolyte panel, serum creatinine, iron studies, folate, vitamin B12, TSH, fasting blood glucose). 2. Unstable cardiovascular or respiratory disease. 3. Patients already meeting the WHO physical activity recommendations before inclusion (IPAQ score ≥1500). 4. Current pregnancy or pregnancy planned during the study period. 5. Inability, for technical or other reasons, to connect to the Internet for telemonitoring and/or telerehabilitation. 6. Planned surgery requiring hospitalization. 7. Refusal to participate. 8. Persons under legal guardianship or deprived of liberty. 9. Uncontrolled diagnosed psychiatric disorder. 10. Participant currently in an exclusion period for another clinical study. 11. Participant who cannot be contacted in case of an emergency. 12. Any surgery planned during the first 6 months of the study that requires hospitalization.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Grenoble Alpes
Grenoble, 38700, France
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