The primary objective is to investigate the effect of prolonged and repeated moderate intensity exercise on faecal calprotectin in patients with IBD. Secondary objectives will be to investigate the effect on inflammatory markers and clinical disease…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in gastrointestinal inflammation
measured by faecal calprotectin in the IBD subjects.
Secondary outcome
Secondary parameters are inflammatory markers in blood and clinical disease
activity measured by Harvey Bradshaw Index (HBI) in Crohn*s Disease and the
Simple Clinical Colitis Activity Index (SCCAI) in ulcerative colitis.
Background summary
Despite the fact that several studies suggest a role for exercise in
maintenance of remission and improving quality of life in IBD, patients often
express their concern that physical activity will aggravate their disease.
Indeed, most of the studies are based on short exercise bouts or low intensity
exercise and often lack objective markers of inflammation. More insight in the
effect of prolonged and repeated exercise is necessary to provide patients with
sound advice.
Study objective
The primary objective is to investigate the effect of prolonged and repeated
moderate intensity exercise on faecal calprotectin in patients with IBD.
Secondary objectives will be to investigate the effect on inflammatory markers
and clinical disease activity.
Study design
This observational study will take place during the Nijmegen Four Days Marches
(NFDM) (July 16, 2019 * July 19, 2019).
Study burden and risks
Subjects need to visit the research unit five times during the NFDM for
measurements. Five times blood samples will be taken and three times they are
asked to bring a faecal sample. Additionally, they need to fill in online
questionnaires. Since this is an observational study, the additional risk for
the subjects is minimal.
Philips van Leijdenlaan 15
Nijmegen 6525EX
NL
Philips van Leijdenlaan 15
Nijmegen 6525EX
NL
Listed location countries
Age
Inclusion criteria
- 18 years of age or older (all participants)
- Diagnosis of Crohn*s disease or ulcerative colitis (total or left-sided
colitis) made by gastroenterologist (IBD participants)
- Participation in Nijmegen Four Day Marches, edition 2019 (all participants)
Exclusion criteria
- Use of biologicals (e.g. infliximab, adalimumab, golumimab, ustekinumab) (IBD
participants)
- History of IBD or other gastro-intestinal diseases such as celiac disease or
Irritable Bowel Syndrome (IBS) (healthy participants)
- History of significant systemic diseases, such as diabetes mellitus, cancer,
cardiovascular or respiratory disease, that may have an effect on study
outcomes (healthy participants)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL69804.091.19 |
| OMON | NL-OMON27563 |