Inflammatory bowel disease (IBD) AND Crohn's disease / ulcerative colitis
Conditions
Interventions
A 12-week exercise program consisting of three times per week 1-hour sessions,
including 30-minutes aerobic- and 30-minutes progressive resistance training at
personalised intensity based on cardiop
Sponsors
Rijnstate Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - >= 1 year diagnosis of IBD (including Crohn*s disease, ulcerative colitis and IBD-unclassified) based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria; - Severe fatigue complaints >3 months as confirmed with a score of >=11 on section I of the inflammatory bowel disease fatigue self-assessment scale (IBD-F); - Clinically quiescent IBD with a Harvey Bradshaw Index (HBI)
Exclusion criteria
Exclusion criteria: - Intensive sport activities more than once a week / >90 minutes in the past year. - Past surgery within 6 months before or planned surgery 12 months after the screening visit - Comorbidities that could be confounders for fatigue; (such as severe cardiorespitory disease, active malignancy, post-COVID or treatment for a psychiatric disorder) -Comorbidities that prevent safe participation in the exercise program/cardiorespiratory fitness test (including cardiorespitory diseases, BMI>=35, physical disabillities that compromise exercise performances). - Pregnant at the moment of the screening visit or planning pregnancy within 12 months after the screening. - Participation in another medical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fatigue and quality of life after 12-weeks physical exercise in the intervention group compared to the control group. (short term, after 3 months) Fatigue complaints will be measured with the inflammatory bowel disease fatigue self-assessment scale (IBD-F) and quality of life will be measured with the IBD-questionnaire (IBDQ). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Long-term changes in fatigue and quality of life as measured after 6- and 12-months using the IBD-F and IBDQ questionnaires in the intervention group compared to the control group; • Changes in cardiorespiratory fitness and muscular strength of patients in the intervention group after 3 months (post-intervention) assessed using CPET (including maximum power and VO2max) and strength measurements using 1-RM; • Change in body composition in the intervention group after 3 months (post-intervention): body fat percentage measured using skinfold techniques and BMI; • Change in work productivity and activity impairment using the work productivity cost questionnaire in the intervention group compared to the control group; • Disease activity measured by faecal calprotectin, exacerbation rate and step-up therapy rate in both the intervention- and control group; • Self-reported differences in sleep quality in the intervention group compared to the control group, using the Pittsburgh Sleep Quality Index (PSQI); • Differences in Anxiety and depression symptoms in the intervention group compared to the control group, measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire; • Economic evaluation of the intervention using a cost-utility analysis from a societal perspective including intervention costs, medical consumption costs, non-medical patient costs and productivity loss. Effectiveness of the intervention will be determined using the mean difference of quality adjusted life years (QALYs) between de intervention and control group, based on designated EQ-5D-5L questionnaire; • Exploratory: differences in the immunological profiles, microbiome diversity and composition using 16SRNA sequencing and concentration of targeted metabolites (short-chain fatty acids and tryptophan metabolites). | — |
Countries
Netherlands
Outcome results
None listed