Inflammatory Bowel Diseases (IBD)cAPAbleNCT07804511
Adapted Physical Activity for Persistent Fatigue in Patients With Inflammatory Bowel Disease in Remission
A study testing Adapted Physical Activity in people with Inflammatory Bowel Diseases (IBD) and Fatigue, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases (IBD), Fatigue, Crohn Disease (CD)
- What is being tested?
- Adapted Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2027to Feb 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- Unstable cardiovascular or respiratory disease.
- 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.
- Planned surgery requiring hospitalization.
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- Refusal to participate.
- Persons under legal guardianship or deprived of liberty.
- Uncontrolled diagnosed psychiatric disorder.
- Participant currently in an exclusion period for another clinical study.
- Participant who cannot be contacted in case of an emergency.
- Any surgery planned during the first 6 months of the study that requires hospitalization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Grenoble Alpes
Grenoble, 38700
Mbene FALL, 0695038784, mfall2@chu-grenoble.fr
Anna BOROWIK, 0476769314, ABorowik@chu-grenoble.fr
About this study
Official title: 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.
Read the 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.
- Being tested
- Adapted Physical Activity, Usual Care
- Keywords
- Inflammatory bowel disease, Persistent fatigue, Adapted physical activity, Disease remission
- Medical subject headings
- Inflammatory Bowel Diseases, Fatigue, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical ActivityBehavioural
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 CareOther
Participants will receive usual care according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity | Experimental | A 6-month adapted physical activity program tailored to the participant's individual physical abilities and needs. Receives: Behavioral: Adapted Physical Activity |
| Usual Care | Other | Participants will receive usual care according to standard clinical practice. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score 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.
Measured: at 6 months
Secondary outcomes (16)
Fatigue assessed by the FACIT-Fatigue (FACIT-F) score at 3 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.
Measured: At 3 months and 12 months
Quality of life assessed by the Inflammatory Bowel Disease Disability Index (IBD-Disk)
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.
Measured: At 3 months, 6 months and 12 months
Physical condition assessed by Body weight
Body weight (kg) - mean values are compared between the adapted physical activity arm and the standard care arm.
Measured: At 6 months and 12 months
Physical condition assessed by body mass index
Body mass index (kg/m²) - Mean values are compared between the adapted physical activity arm and the standard care arm.
Measured: At 6 months and 12 months
Physical condition assessed by waist circumference
Waist circumference (cm) - Mean values are compared between the adapted physical activity arm and the standard care arm.
Measured: At 6 months and 12 months
Physical condition assessed by handgrip strength
Handgrip strength measured by dynamometer (kg) - Mean values are compared between the adapted physical activity arm and the standard care arm.
Measured: At 6 months and 12 months
Health care resource use
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.
Measured: At 6 months and 12 months
Health care resource use
Proportion 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.
Measured: At 6 months and 12 months
State anxiety assessed by the State-Trait Anxiety Inventory - State subscale (STAI-State)
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.
Measured: At 6 months and 12 months
Depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: At 6 months and 12 months
Clinical disease activity assessed by the Patient-Reported Outcomes 2 (PRO2)
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.
Measured: At 3 months, 6 months and 12 months
Biological disease activity assessed by C-reactive protein (mg/L)
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.
Measured: At 3 months, 6 months and 12 months
Biological disease activity assessed by Faecal calprotectin (µg/g)
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.
Measured: At 3 months, 6 months and 12 months
Physical activity level assessed by the International Physical Activity Questionnaire (IPAQ)
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.
Measured: At 3 months, 6 months and 12
Functional capacity assessed by the 6-minute walk test
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.
Measured: At 6 months and 12 months
Correlation between a fatigue visual analogue scale and the FACIT-Fatigue score
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.
Measured: At 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startJun 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Diseases (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804511
- Sponsor's protocol ID
- 38RC24.0272
- Acronym
- cAPAble
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No