Viewing Study NCT03639259



Ignite Creation Date: 2024-05-06 @ 11:56 AM
Last Modification Date: 2024-10-26 @ 12:52 PM
Study NCT ID: NCT03639259
Status: COMPLETED
Last Update Posted: 2021-06-29
First Post: 2018-08-07

Brief Title: Emotional and Cognitive Determinants of Post-stroke Fatigue
Sponsor: University Hospital of North Norway
Organization: University Hospital of North Norway

Study Overview

Official Title: Emotional and Cognitive Determinants of Post-stroke Fatigue A Prospective Study
Status: COMPLETED
Status Verified Date: 2021-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Fatigue is a prevalent prolonged and partly disabling symptom following cerebral stroke The health services has little knowledge of fatigue both in terms of what characterizes those affected and with regard to how fatigue can be treated Persons going through a stroke may experience impairments in cognitive functions such as attention and memory This will often cause previously effortless activities of daily living to become strenuous and exhausting Experiencing a stroke will also in many cases lead to a major change in life due to other related loss of function grief and health-related concerns Emotional reactions like depression and anxiety are widespread

Specific knowledge of how cognitive impairment emotional reactions and coping strategies contribute to development and maintenance of fatigue is lacking The present research project will contribute with new and important knowledge in this area

A total of 250 adults have been followed up after stroke with multiple examinations Average age at the time of stroke was 70 years The investigators now plan to follow them up three to four years after stroke This provides a unique opportunity to investigate how depression and anxiety over time may be related to the experience of fatigue cognitive impairment and negative coping strategies such as worrying and rumination The investigators will use questionnaires and cognitive tests when examining these associations Such new knowledge about cognitive and emotional factors related to the development of fatigue long-term after stroke may help determine who is at risk of developing symptoms of fatigue Furthermore it can shed light on possible preventional measures and provide better suited advice to those affected by fatigue This knowledge can also pave the way for new research-based treatment methods
Detailed Description: Fatigue is a common symptom after stroke experienced by 25 - 92 Fatigue predicts reduced physical health and has a negative impact on everyday life Causes are poorly investigated and not fully understood Recent studies indicate that specific cognitive functions are related to the development of fatigue but findings are not consistent There are few studies with adequate neuropsychological tests and an adequate number of participants Moreover it is not clear whether anxiety or depression may predict later occurrence of fatigue after stroke or how coping strategies affect the process

The purpose of this study is to investigate 1 the association between cognitive factors as measured with neuropsychological tests and fatigue 3-4 years after cerebral stroke 2 whether emotional factors 3 and 12 months after stroke predict development of fatigue long-term 3-4 years after stroke and 3 the association between fatigue and different domains of stroke-specific health-related quality of life 3-4 years after the stroke Metacognitive thinking style are treated as a possible mediator of the association of depressionanxiety and fatigue after stroke Physical activity and sleep measured with accelerometer are treated as mediators of the association of both emotional and cognitive factors and fatigue

Identification of factors relevant to the development of fatigue and increased knowledge of the consequences of fatigue for health-related quality of life will provide greater understanding of mechanisms contribute to early identification of fatigue and better adapted rehabilitation and thereby increased function and quality of life

The following articles will be published as part of this project

1 The association between cognitive functioning and fatigue long-term post-stroke A cross-sectional study with neuropsychological tests
2 Anxiety and depression as predictors for long-term fatigue after stroke A prospective study
3 Metacognitions and thought control strategies in patients with post stroke fatigue
4 The association between fatigue and health-related quality of life A prospective study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None