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

ConditionsInflammatory Bowel Diseases (IBD)FatigueCrohn Disease (CD)Ulcerative Colitis (UC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Participants will receive usual care according to standard clinical practice.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Adapted Physical ActivityExperimental treatment 1 intervention
Group B: Usual CareOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at 6 months

Secondary outcomes

1

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.

Time frame
At 3 months and 12 months
2

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.

Time frame
At 3 months, 6 months and 12 months
3

Physical condition assessed by Body weight

Body weight (kg) - mean values are compared between the adapted physical activity arm and the standard care arm.

Time frame
At 6 months and 12 months
4

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.

Time frame
At 6 months and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Grenoble

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: