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

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

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

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

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

Physical condition assessed by waist circumference

Waist circumference (cm) - Mean values are compared between the adapted physical activity arm and the standard care arm.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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