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

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.

Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic conditions that can affect patients' daily lives even when the disease is in remission. Persistent fatigue is a common and disabling symptom that may remain despite control of intestinal inflammation.

The cAPAble study will evaluate whether an adapted physical activity (APA) program can help reduce persistent fatigue in patients with IBD in remission. This is a multicenter randomized interventional study. Participants will be randomly assigned to an adapted physical activity program or usual care.

The APA program is designed to be adapted to each participant's physical abilities and needs and will be delivered over 6 months. The program aims to progressively increase physical activity and support participants in maintaining regular physical activity in their daily lives.

The main purpose of the study is to determine whether participation in the APA program improves persistent fatigue. The study will also explore potential effects on physical activity, quality of life, psychological well-being and other aspects of participants' health and daily functioning.

Participants will be followed throughout the study according to the protocol, with assessments performed at predefined time points using validated questionnaires and other study assessments. The results of the study may help improve the management of persistent fatigue in people with IBD in remission and contribute to the development of supportive non-drug approaches for these patients.

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.