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Adapted Physical Activity for Persistent Fatigue in Patients With Inflammatory Bowel Disease in Remission
Condition(s) studied
Inflammatory Bowel Diseases (IBD)FatigueCrohn Disease (CD)Ulcerative Colitis (UC)
Investigational drug(s) / intervention(s)
Adapted Physical ActivityUsual Care
Adapted Physical Activity: A 6-month adapted physical activity program tailored to each participant's physical abilities and individual needs. The program consists of 12 one-hour sessions delivered every two weeks, followed by 2 months of telephone follow-up to support participants in maintaining regular physical activity.
Usual Care: Participants will receive usual care according to standard clinical practice.
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Mean Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at 6 months. — at 6 months
Mean Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score in each study arm at 6 months. The FACIT-F scale ranges from 0 to 52, with higher scores indicating less fatigue and better quality of life.
Trial sites (1)
| Facility | City | Region | Status |
| CHU Grenoble Alpes |
Grenoble |
France |
|
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