The effectiveness of a sports program on fatigue and QoL in IBD patients with quiescent disease
- Conditions
- Inflammatory Bowel Disease/IBD/Crohn's disease and Ulcerative colitis1001796910003816
- Registration Number
- NL-OMON44410
- Lead Sponsor
- Rijnstate Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- The diagnosis of IBD must be based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria in the past.
- Both patients with Crohn*s disease, Ulcerative colitis and IBD-unclassified in remission (SES-CD 0-2 and Mayo score 0).
- The faecal calprotectin must be below 50.
- Fatigue level on the Checklist Individual Strenght fatigue must be above or equal to 35 (CIS-F score *35)
- Stable medication for at least 4 weeks before the screening visit.
- Patients must be able and willing to provide written informed consent.
- Patients between the age of 25 and 60 years, both men and women.
- IBD diagnosis within one year before the screening visit.
- Intensive sport activities more than once a week in the past year.
- Operation within 6 months before or 3 months after the screening visit
- Coexistent chronic diseases for example heart failure, COPD an malignancies.
- Pregnant at the moment of the screening visit or planning pregnancy within 3 months after the screening.
- Participation in another medical research.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in fatigue complaints measured with the CIS-F checklist and in quality<br /><br>of life measured with the IBD-Q checklist.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Physical fitness including cardiorespiratory fitness, muscle strength and body<br /><br>composition. </p><br>