The study aims to determine whether fitness and daily physical activity determine fatigue in patients with IBD. Therefore we will examine whether there is a relationship between fitness, daily physical activity and fatigue in these patients. It will…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To what extent patients with IBD have a reduced level of daily physical
activity compared to healthy population?
2. To what extend the level of fitness is decreased in IBD patients compared to
healthy population?
3. Is the level of daily physical activity related to the severity of fatigue ?
4. Is fitness related to the severity of fatigue in patients with IBD?
Secondary outcome
1. What is the relationship between fitness and physical activity daily?
2. Is fitness and / or daily physical activity related to the quality of life
in patients with IBD?
Background summary
Inflammatory bowel disease (IBD) are chronic intestinal inflammation. IBD is
subdivided into two subcategories: Ulcerative colitis (UC) and Crohn's disease
(CD). Annual 1500 IBD patients visit the outpatient clinic of the Erasmus MC.
The average frequency of visits is twice a year, but this frequency increases
to once a month in about 60% of patients. Reasons for this increased frequency
of visits are: active disease, side effect of medication and fatigue. It is
known that at least 41% of patients without active disease suffer from extreme
fatigue.
Fatigue could result in a defensive and ineffective use of medical care and
resources and thus to more frequent visits, more tests and regularly changing
treatment. It is also possible that patients because of their complaints have
less physical activity and poor fitness and so a vicious circle which
complaints may continue to deteriorate.
An inactive lifestyle and low fitness may also have a negative impact on
health-related quality of life and is associated with an increased risk of
getting heart disease, diabetes and cancer. Several studies have shown a
positive effect of physical activity to the quality of life and mental
wellbeing.
Nevertheless, IBD patients there is no treatment to promote physical activity
in daily life and improving fitness. Reason for this, probably lies in the fact
that there is currently little knowledge about physical activity, fitness and
the relationship with fatigue in this patient group.
Therefore there is a demand for evaluation studies of interventions in IBD
patients with extreme fatigue and impaired quality of life. Knowledge of
determinants of fatigue in IBD is necessary to develop interventions for
successful rehabilitation of patients with IBD.
Study objective
The study aims to determine whether fitness and daily physical activity
determine fatigue in patients with IBD. Therefore we will examine whether there
is a relationship between fitness, daily physical activity and fatigue in these
patients. It will also examine whether there is a relationship between fitness,
physical activity and quality of life in patients with IBD.
This exploratory pilot study will possibly direct the development of a
rehabilitation program for patients with IBD fatigue. Upon completion of this
investigation there will be launched an intervention study where the effects of
a rehabilitation program will be investigated.
Study design
prospective pilot study
Study burden and risks
No risks are expected associated with participation. Furthermore, no benefits
are expected with participation.
s Gravendijwal 230
3015 CE Rotterdam
NL
s Gravendijwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Included will be patients, age: 18-65 year, have to be in remission according to the investigator, based on accepted clinical parameters and medical records (CDAI <150, CAI <10 and CRP < 10 or at endoscopy).
Exclusion criteria
Excluded will be patients who are pregnant or breastfeading; surgery 3 months prior or intended after this study; short bowel syndrome, cancer, and underlying psychiatric disorders, other gastrointestinal disorder (other than IBD), contraindication for maximal physical test.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL33396.078.10 |