Primary: to study the frequency and characteristics of fatigue and cognitive disorders after minor stroke. Secondary: to gain more insight in the aetiology of post-stroke fatigue and evaluate the impact of post-stroke fatigue on personal and social…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Prevalence of post-stroke fatigue at 3 months and 1 year after a minor
stroke, defined as an FSS (Fatigue Severity Scale) score >= 4 in combination
with a validated case definition for post-stroke fatigue (*Over the past month,
there has been at least a 2-week period when patient has experienced fatigue, a
lack of energy, or an increased need to rest every day or nearly every day.
This fatigue has led to difficulty taking part in everyday activities*)
- Characteristics of post-stroke fatigue as assessed by the MFI-20
(Multidimensional Fatigue Inventory) and a semistructured interview
- Prevalence of cognitive disorders at 4 months after stroke, with cognitive
disorders defined as a score < 25th percentile on >= 2 cognitive subdomains
AND/OR a score < 5th percentile on 1 cognitive subdomain (as compared to norm
groups)
- Characteristics of cognitive disorders: description of the neuropsychological
profile of minor stroke patients with cognitive deficits
Secondary outcome
- Correlations of anxiety and depression, coping, sleep disturbances, pro- and
anti-inflammatory markers, stroke characteristics and cognitive dysfunction
with fatigue
- Correlations of quality of life, return to work and activity level with
fatigue
Background summary
Post-stroke fatigue and cognitive disorders frequently occur in a general
stroke population. A formal evaluation in a minor stroke population is lacking,
but even in the absence of major neurological deficits, fatigue and cognitive
disorders may have a major impact on quality of life after stroke. However, the
underlying mechanisms are poorly understood. A number of pathogenic correlates
have previously been proposed (such as depression, coping, sleeping disorders,
inflammation, stroke characteristics, and neuroendocrine dysregulation).
However, these different systems have never been studied in parallel and their
differential contributions to fatigue and cognitive disorders after a minor
stroke are unknown.
Study objective
Primary: to study the frequency and characteristics of fatigue and cognitive
disorders after minor stroke.
Secondary: to gain more insight in the aetiology of post-stroke fatigue and
evaluate the impact of post-stroke fatigue on personal and social outcome.
Study design
Prospective observational study (longitudinal design).
Study burden and risks
No risk is related to participation in this study. The extensive
characterisation of fatigue and cognitive disorders after stroke as well as the
focus on explanatory variables through history taking, physical examination,
questionnaires, laboratory investigation and imaging, may pose a burden on the
patient, but has the goal to better understand and potentially alleviate the
disease burden of stroke.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
a. Clinical first-ever minor ischemic stroke (with minor defined as National Institutes of Health Stroke Scale [NIHSS] score <= 5 within 24 hours after onset)
b. Age 18 years or older
c. Previously independent for their daily living activities
d. Exhibiting sufficient cognitive functioning to participate (score on the mini-mental state examination (MMSE) >20)
Exclusion criteria
a. Not having enough understanding of the Dutch language
b. Not being able to attend follow-up visits due to home address outside catchment area of UMCG
c. Prior disability (modified Rankin Scale [mRS] > 1)
d. Presence of one or more of the following in the 15 days prior to inclusion: chronic inflammatory diseases, severe hepatic or renal diseases, haematological diseases, cancer, infectious disease, anti-inflammatory or immune suppressing therapy
e. Pre-existent neurological or psychiatric illnesses (as described in the patient*s medical file)
f. No informed consent
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 | NL38873.042.12 |