Primary Objective: To assess the difference in prevalence of pituitary dysfunction between patients with and patients without fatigue after ischemic stroke. Secondary Objectives: 1. To assess the time course of pituitary dysfunction after ischemic…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence of pituitary dysfunction and fatigue after ischemic stroke.
Secondary outcome
Other study outcomes are depression, cognitive performance, functional status,
laboratory dysfunction, pain, illness representation, stroke location, stroke
severity, stroke classification, cardiovascular risk factors, sleep apnoea and
sleepiness.
Background summary
Fatigue affects between 36-77% of stroke survivors at different time intervals
and could be a constraint for rehabilitation. The exact etiology of post
stroke fatigue is unknown. One possible explanation for fatigue is pituitary
dysfunction. A better understanding of the processes involved in poststroke
fatigue may assist in developing rational interventions and improve outcome. We
aim to assess the role of pituitary dysfunction in fatigue after ischemic
stroke with a routine hormone screening protocol. A secondary aim is to study
other determinants of fatigue after ischemic stroke, including depression, use
of medication, laboratory disturbances and sleep apnoea disorder. Furthermore,
we would like to assess the association between appearance of infra-slow
activity, functional outcome and fatigue after ischemic stroke.
Study objective
Primary Objective:
To assess the difference in prevalence of pituitary dysfunction between
patients with and patients without fatigue after ischemic stroke.
Secondary Objectives:
1. To assess the time course of pituitary dysfunction after ischemic stroke.
2. To assess predictors of pituitary dysfunction after ischemic stroke.
3. To assess the association between pituitary dysfunction and depression,
cognitive performance and functional status after ischemic stroke.
4. To assess independent predictors for poststroke fatigue, including pituitary
dysfunction, depression, use of medication, comorbidity, laboratory
disturbances, pain, illness representation, stroke location, stroke severity
and sleep apnoea disorder.
5. To assess the association between fatigue and functional status after
ischemic stroke.
6. To assess the association between appearance of infra-slow activity,
functional outcome and fatigue after ischemic stroke.
Study design
This is a prospective observational cohort study.
Study burden and risks
Patients will be assessed at enrolment, and at 3 months, 6 months and 12 months
thereafter, with an estimated duration of 1 hour for each visit. Besides
standard treatment at enrolment, during all assessments patients will undergo a
general physical examination, a questionnaire and a routine hormone screening
protocol. In case of abnormal hormonal values, additional tests will be
performed to assess the level of dysfunction. At inclusion, EEG-registration of
1 hour will be performed. At inclusion and at 12 months a standardized blood
test will be performed for blood count, renal and liver function, glucose and
CRP. At 3 months and 12 months a cognitive function test and attention span
test will be performed. All patients will undergo a polygraph at 12 months. A
subgroup will ondergo an extended neuropsychological test. Since this is an
observational study with no invasive diagnostic or therapeutic interventions,
we judge the chance of an adverse event to be low.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
Patients will be eligible for inclusion if they are 18 years or older and have a clinical diagnosis of first ever ischemic stroke. Patients should have an NIHSS score of * 2 and be expected to be discharged to a rehabilitation unit or to home.
Exclusion criteria
Patients will be excluded when they:
- are treated with chemotherapeutics
- are receiving (oral or intravenous) corticosteroid therapy for more than 1 month (not: inhalation corticosteroids)
- are pregnant
- are not able to complete a questionnaire due to severe aphasia, non-Dutch speaking or severe cognitive disturbances.
- have a history of:
*- hypothalamic/pituitary disease that significantly affects the study results, e.g. Cushing*s disease.
*- cranial irradiation or another significant intracranial lesion
*- multiple sclerosis
*- chronic fatigue syndrome
*- psychiatric condition that interferes with interpretation of the study
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 | NL52674.044.15 |
| OMON | NL-OMON27430 |