Crohn'sUCNot yet recruiting

Adapted Physical Activity for Persistent Fatigue in Patients With Inflammatory Bowel Disease in Remission

Not applicable · Testing Adapted Physical Activity and Usual Care · 1 site · University Hospital, Grenoble

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Adapted Physical Activity (a behavioral program) and Usual Care as supportive care (to help with symptoms or quality of life). Condition(s) listed: Inflammatory Bowel Diseases (IBD), Fatigue and Crohn Disease (CD).

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).

Who can join

Ages 18 and older
Any sex

Some of the main requirements, copied from the record:

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.

Plus 4 more requirement(s). There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 120 participants are expected to take part.
Start date: 2027-06 (planned).
Main results expected around 2028-12 (estimate from the record).
1 study site listed in France.

Main thing being measured

Mean Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at 6 months. (at 6 months)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional
Conditions	Inflammatory Bowel Diseases (IBD); Fatigue; Crohn Disease (CD); Ulcerative Colitis (UC)
Lead sponsor	University Hospital, Grenoble
Enrollment	120 (estimated)
Start date	2027-06
Primary completion (est.)	2028-12
First posted	2026-09-04
Last updated	2026-09-11
Official title	Impact of Adapted Physical Activity on Persistent Fatigue in Patients With Inflammatory Bowel Disease in Remission
ClinicalTrials.gov ID	NCT07804511

Interventions

Adapted Physical Activity (Behavioral)
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 (Other)
Participants will receive usual care according to standard clinical practice.

Full eligibility criteria (from the record)

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.

Locations (1)

Site	City	Country	Site status
CHU Grenoble Alpes	Grenoble	France

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.