NCT07804511Not yet recruiting
Adapted Physical Activity for Persistent Fatigue in Patients With Inflammatory Bowel Disease in Remission
Impact of Adapted Physical Activity on Persistent Fatigue in Patients With Inflammatory Bowel Disease in Remission
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
The cAPAble study aims to evaluate the impact of an adapted physical activity program on persistent fatigue in patients with inflammatory bowel disease in remission. This multicenter randomized study will include 120 participants. Participants will be randomly assigned to either a 6-month adapted physical activity program or usual care. Fatigue will be assessed using the FACIT-F questionnaire at 6 months.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 31 Aug 2026
- Start date
- Jun 2027
- Primary completion date
- Dec 2028
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07804511
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Jun 2027 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgery requiring hospitalization.
- Any surgery planned during the first 6 months of the study that requires hospitalization.
Other illness
- Unstable cardiovascular or respiratory disease.
- Uncontrolled diagnosed psychiatric disorder.
Lab values
- 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).
Other
- Patients already meeting the WHO physical activity recommendations before inclusion (IPAQ score ≥1500).
- Current pregnancy or pregnancy planned during the study period.
- Inability, for technical or other reasons, to connect to the Internet for telemonitoring and/or telerehabilitation.
- Refusal to participate.
- Persons under legal guardianship or deprived of liberty.
- Participant currently in an exclusion period for another clinical study.
- Participant who cannot be contacted in case of an emergency.
Who the study is looking for
- 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.
- 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.
- Adults aged 18 years or older.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.