This study will investigate fatigue after exercise in sarcoidosis patients. It will determine the severity of their fatigue, the recuperative capacity after maximal exertion (bicycle ergometer) and the levels of ACE and cytokines (before and after…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recuperative capacity: Outcome on two maximal exercise tests (bicycle
ergometer): comparing results of cardiovascular, pulmonary and aerobic capacity
on two successive days.
Fatigue: State of fatigue (before and after exercise) will be evaluated by
Visual Analogue Scales. Trend of fatigue (at the start of taking part in this
study and after completing) will be measured with the CIS-20R-08-questionnaire.
Measurements in serum: Level of ACE, including genotype of patients for ACE and
levels of cytokines will be determined (IL-6 and TNF-α before and after
exercise).
Secondary outcome
Secondary objective is to find associations between exercise and patterns of
sleep behaviour and acitivity, not only on basis of patient reports, but also
objectified bij means of an accelerometer.
Background summary
Fatigue is an often reported complaint by patients suffering from sarcoidosis,
especially during the onset and the active phase of this multi-systemic
granulomatous disorder. However, when sarcoidosis patients are tested for
cardiovascular, pulmonary, and aerobic capacity by means of exercise tests, the
results of these tests are usually within normal limits. Nonetheless a lot of
these patients state that after completing the exercise test they are totally
exhausted. Their complaints are so severe that they cannot do their daily work
the same and the next day(s).
This study examines if excessive complaints of fatigue in sarcoidosis patients
after exercise can be objectified. It hypothesizes that the recuperative
capacity in sarcoidosis is decreased, probably due to an increase in levels of
ACE and cytokines in blood, as result of the disease. Until now this particular
phenomenon of exhaustion after exercise has never been studied before in
sarcoidosis patients.
Study objective
This study will investigate fatigue after exercise in sarcoidosis patients. It
will determine the severity of their fatigue, the recuperative capacity after
maximal exertion (bicycle ergometer) and the levels of ACE and cytokines
(before and after exercise) in these patients. Results in sarcoidosis patients
will be compared to results of a control group of healthy volunteers.
Our secondary objective is to find associations with sleep behaviour and
activity pattern.
Study design
This study is a pilotstudy to instigate a prospective observational study.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Participants will visit the hospital on 3 days:
2 times successively to complete the exercise test and a 3rd time to collect a
last blood sample. In addition they are asked to keep a sleep- and activity
diary, and to wear an actometer during a period of 14 days.
The aerobic capacity during the exercise test is registered by means of a
combined sensor for CO2 en SaO2 measurement (TOSCA 500 Monitoring System),
which is applied to the ear lobe. This has a tremendous benefit because it is
obviously not invasive (there is no arterial line needed). The only risks of
the study comprises a haematoma as result of venous bloodsampling.
This study could give insight in pathways of fatigue during a systemic disease.
Fatigued sarcoidosis patients might benefit from this study if physical factors
can be found that can explain their exhaustion after exercise. This information
is not only helpful in their private life, but can also clarify their
incapacity to work. In this respect it could be used in labour disputes in
which a lot of these sarcoidosis patients are involved. If a relationship
between fatigue and cytokine levels can be established, in the future patients
may benefit from anticytokine therapy.
Wagnerlaan 55
6815 AD Arnhem
NL
Wagnerlaan 55
6815 AD Arnhem
NL
Listed location countries
Age
Inclusion criteria
Sarcoidosis
diagnosis confirmed within 1 year before inclusion
18 years and older
informed consent
see protocol section 4.2
Exclusion criteria
corticosteroid use, cardiovasculair comorbidity
see protocol section 4.3
Design
Recruitment
Medical products/devices used
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 | NL28093.091.09 |