| Trial Status | Open |
|---|---|
| Overall study start date | 15-02-2023 |
| Overall study end date | |
| Country | The Netherlands |
| Trial Number | NL-OMON51459 |
| Trial URL | https://onderzoekmetmensen.nl/en/trial/51459 |
| Summary | Fatigue significantly impacts the quality of life (QoL) of patients with inflammatory bowel disease (IBD) and is observed in 40% of patients with quiescent disease. Specific treatment strategies are currently lacking. Physical exercise might be an effective complementary treatment for fatigue, as our previous pilot-study has demonstrated a benificial effect on fatigue and QoL in IBD-patients. However trials with more evidence, such as a randomized controlled trial, on the potential beneficial effect of physical exercise on IBD-related fatigue is needed. Additionally, the long-term effects and cost-effectivity of such intervention has not been determined before. |
| Study Design | Randomized controlled trial |
| Study Setting(s) | Hospital |
| Study Acronym | Inflammatory bowel disease (IBD) AND Crohn's disease / ulcerative colitis |
| Study Hypotheses | |
| Condition | Inflammatory Bowel Disease |
| Intervention | 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 cardiopulmonary exercise test (CPET) and one-repetition maximum (1-RM). The training sessions will be performed in groups of 10 participants under supervision of a sports physiotherapist. |
| Primary Outcome Measure | 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 Outcome Measure | 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). |
Eligibility
| Participant Type(s) | Inflammatory Bowel Disease |
|---|---|
| Age Group | Adult (18-64), Senior (65+) |
| Sex | Males |
| Target Number of Participants | 100 |
| Total Final Enrolment | |
| Participant 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) 5 for Crohn*s disease patients or a Simple Colitis Clinical Activity Index (SCCAI) =2 for patients with ulcerative colitis or IBD-unclassified; - Faecal calprotectin 100 µg/g; - Stable medication for at least 3 months before screening visit; - Patient is able and willing to provide written informed consent; - Patient is able/commitment to make a time investment to complete the intervention program (one hour training 3x/week during 12 weeks); - Patient is aged between 18 and 67 years |
| Participant 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. |