|- candidate number||22502|
|- NTR Number||NTR5330|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-jul-2015|
|- Secondary IDs||NL52674.044.15 |
|- Public Title||Fatigue after ischemic stroke: association with pituitary dysfunction|
|- Scientific Title||Pituitary dysfunction in association with fatigue after ischemic stroke|
|- hypothesis||The hypothesis is that poststroke fatigue is associated with pituitary dysfunction.|
Other factors associated with poststroke fatigue, e.g. sleep apnoea and laboratory dysfunction, will be investigated as well.
|- Healt Condition(s) or Problem(s) studied||Ischemic stroke, Fatigue, Pituitary disease|
|- Inclusion criteria||A subject must meet all of the following criteria:|
- 18 years or older;
- NIHSS score12 of ¡Ư 2;
- be expected to be discharged to a rehabilitation unit or to home.
|- Exclusion criteria||Patients will be excluded when they:|
- are being 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 and/or psychiatric condition that interferes with interpretation of the study.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2015|
|- planned closingdate||1-okt-2017|
|- Target number of participants||118|
|- Interventions||Besides standard treatment at enrolment, patients will undergo a general physical examination, a questionnaire, a cognitive performance test, a polygraph, a standardized fasting blood test and a routine hormone screening protocol. In case of abnormal hormonal values, additional tests will be performed to assess the level of dysfunction.|
|- Primary outcome||To assess the difference in prevalence of pituitary dysfunction between patients with and patients without fatigue after ischemic stroke. |
|- Secondary outcome||1. To assess the time course of pituitary dysfunction after ischemic stroke.|
2. To assess predictors of pituitary dysfunction after ischemic stroke, including stroke severity, stroke location and demographic factors.
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.
|- Timepoints||Patients will be assessed at enrolment, and at 3 months, 6 months and 12 months thereafter.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||dr. A. Beishuizen|
|- CONTACT for SCIENTIFIC QUERIES||dr. A. Beishuizen|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Medisch Spectrum Twente|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||24-jul-2015 - 25-aug-2015|