Crohn Disease (CD), Fatigue, Inflammatory Bowel Diseases (IBD), Ulcerative Colitis (UC)
Conditions
Keywords
Inflammatory bowel disease, Persistent fatigue, Adapted physical activity, Disease remission
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALAdapted 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.
OTHERUsual Care
Participants will receive usual care according to standard clinical practice.
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue assessed by the FACIT-Fatigue (FACIT-F) score at 3 and 12 months | At 3 months and 12 months | The FACIT-Fatigue subscale is a 13-item self-administered questionnaire. The total score ranges from 0 to 52; a higher score indicates less fatigue (better outcome). Mean scores are compared between the adapted physical activity arm and the standard care arm. |
| Quality of life assessed by the Inflammatory Bowel Disease Disability Index (IBD-Disk) | At 3 months, 6 months and 12 months | The Inflammatory Bowel Disease Disability Index (IBD-Disk) is a 10-item self-administered instrument. Each item is rated on a numerical scale from 0 to 10, resulting in a total score ranging from 0 to 100. Higher scores indicate greater disability and poorer quality of life. Mean IBD-Disk scores will be compared between the adapted physical activity arm and the standard care arm. |
| Physical condition assessed by Body weight | At 6 months and 12 months | Body weight (kg) - mean values are compared between the adapted physical activity arm and the standard care arm. |
| Physical condition assessed by body mass index | At 6 months and 12 months | Body mass index (kg/m²) - Mean values are compared between the adapted physical activity arm and the standard care arm. |
| Physical condition assessed by waist circumference | At 6 months and 12 months | Waist circumference (cm) - Mean values are compared between the adapted physical activity arm and the standard care arm. |
| Physical condition assessed by handgrip strength | At 6 months and 12 months | Handgrip strength measured by dynamometer (kg) - Mean values are compared between the adapted physical activity arm and the standard care arm. |
| Health care resource use | At 6 months and 12 months | Number of participants with at least one of the following events, collected using a study-specific health care use questionnaire: hospitalisation, corticosteroid course, change in inflammatory bowel disease therapy, consultation with a general practitioner, consultation with a psychologist, and use of complementary or alternative medicine. Compared between the adapted physical activity arm and the standard care arm. |
| State anxiety assessed by the State-Trait Anxiety Inventory - State subscale (STAI-State) | At 6 months and 12 months | The State-Trait Anxiety Inventory - State subscale (STAI-State) is a 20-item self-administered instrument assessing current state anxiety. The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. Mean STAI-State scores will be compared between the adapted physical activity arm and the standard care arm. |
| Depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9) | At 6 months and 12 months | The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-administered instrument assessing depressive symptoms. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. Mean PHQ-9 scores will be compared between the adapted physical activity arm and the standard care arm. |
| Clinical disease activity assessed by the Patient-Reported Outcomes 2 (PRO2) | At 3 months, 6 months and 12 months | The Patient-Reported Outcomes 2 (PRO2) is a patient-reported measure of ulcerative colitis disease activity based on stool frequency and rectal bleeding. The total score ranges from 0 to 6, with higher scores indicating greater clinical disease activity. Mean PRO2 scores will be compared between the adapted physical activity arm and the standard care arm. |
| Biological disease activity assessed by C-reactive protein (mg/L) | At 3 months, 6 months and 12 months | C-reactive protein (mg/L) - a higher value indicates greater disease activity. Mean values are compared between the adapted physical activity arm and the standard care arm. |
| Biological disease activity assessed by Faecal calprotectin (µg/g) | At 3 months, 6 months and 12 months | Faecal calprotectin (µg/g) - a higher value indicates greater disease activity. Mean values are compared between the adapted physical activity arm and the standard care arm. |
| Physical activity level assessed by the International Physical Activity Questionnaire (IPAQ) | At 3 months, 6 months and 12 | The International Physical Activity Questionnaire (IPAQ) is a self-administered questionnaire; physical activity is expressed in MET-minutes per week. A higher value indicates a higher level of physical activity. Mean values are compared between the adapted physical activity arm and the standard care arm. |
| Functional capacity assessed by the 6-minute walk test | At 6 months and 12 months | Maximal distance walked during the 6-minute walk test, expressed in metres. A greater distance indicates better functional capacity. Mean values are compared between the adapted physical activity arm and the standard care arm. |
| Correlation between a fatigue visual analogue scale and the FACIT-Fatigue score | At 3 months, 6 months and 12 months | Correlation coefficient between the fatigue visual analogue scale (VAS-F, scored from 0 to 10, a higher score indicating more fatigue) and the FACIT-Fatigue score (scored from 0 to 52, a higher score indicating less fatigue), at each assessment time point. This outcome measure is assessed in the whole study population and is not a between-arm comparison. |
Countries
France
Contacts
CONTACTClémence LOMBOIS, Dr
Outcome results
None listed