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临床试验/NCT07231172
NCT07231172招募中不适用

Frequency of Post-stroke Fatigue and Its Relationship With Clinical Parameters

Ankara University1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2024年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
107
试验地点
1
主要终点
Fatigue Severity Scale

研究概览

简要总结

This study aims to determine the frequency of post-stroke fatigue (PSF) in patients experiencing their first-ever stroke and admitted to our clinic. PSF is a common and debilitating condition that significantly impacts patients' recovery and quality of life. The study will also explore the association between fatigue severity and various demographic and clinical factors such as age, gender, stroke type and duration, pain, mood disorders, sleep quality, motor and cognitive functions, spasticity, physical capacity, ambulation, independence in daily living activities, and health-related quality of life. Patients over 18 years old, at least three months post-stroke, and meeting specific inclusion criteria will be recruited. Fatigue will be assessed using validated scales including the Fatigue Severity Scale and Visual Analog Scale-Fatigue. Additional assessments will measure pain, anxiety, depression, sleep disturbances, motor and cognitive status, spasticity, physical endurance, functional mobility, and daily activity independence. The findings are expected to contribute to a better understanding of PSF and help inform more effective rehabilitation strategies.

详细描述

According to the definition of the World Health Organization, stroke is defined as "rapidly developing clinical manifestations of focal (or global) impairment of cerebral function that lasts longer than 24 hours or may result in death and has no apparent cause other than vascular origin". Stroke is the second leading cause of death in the world. It is also the leading cause of disability and accounts for a significant proportion of hospital admissions and health expenditures in industrialized societies. Stroke has many complications, one of which is fatigue. Fatigue can be defined as a decrease in physical and/or mental performance resulting from changes in central, psychological and/or environmental factors. Normal fatigue is a generalized state of tiredness resulting from overexertion and improves with rest. In contrast, "pathologic fatigue", often experienced by patients with neurological disorders, is chronic fatigue unrelated to previous levels of exertion and usually does not improve with rest. Post-stroke fatigue can be considered as a type of pathologic fatigue. Post-stroke fatigue is one of the most common symptoms 3 months after stroke. Half of the patients may still experience fatigue 1 year after stroke and this condition may last for years. The prevalence of post-stroke fatigue has been reported to vary between 39% and 68%. Post-stroke fatigue negatively affects the quality of life of stroke patients and constitutes a significant barrier to recovery, especially in participation in rehabilitation programs. Therefore, understanding post-stroke fatigue is an important issue for healthcare professionals in terms of implementing effective rehabilitation programs in patients with stroke. However, little is known about the etiology and effective management of post-stroke fatigue. Numerous factors have been shown to be associated with post-stroke fatigue, including age, gender, depression, stroke severity, stroke type and lesion location, pain, but these risk factors are not consistent across all studies. The lack of appropriate objective measurement tools may be one of the reasons for the poor understanding of post-stroke fatigue. Several tools are available to assess fatigue, including the Fatigue Rating Scale, Fatigue Impact Scale, Fatigue Severity Scale (FSS) and Visual Analogue Scale-Fatigue. The Fatigue Severity Scale (FSS) is the most commonly used fatigue assessment scale in stroke patients and was originally developed to measure fatigue in patients with Multiple Sclerosis and Systemic Lupus Erythematosus. In the literature, there are studies investigating the frequency of fatigue after stroke and its relationship with various demographic and clinical parameters. In our country, there are a few studies evaluating the frequency of fatigue after stroke. There is no complete clarity in terms of both the frequency and the factors associated with fatigue in the studies. Our primary aim in this study is to determine the frequency of post-stroke fatigue in first-time stroke patients admitted to our clinic. Our secondary aim is to evaluate the relationship between fatigue severity and demographic and clinical characteristics of the patients such as age, gender, education level, stroke type, stroke duration and severity of pain, anxiety, depression, sleep status, motor and cognitive function, spasticity, physical capacity, functional ambulation, level of independence in activities of daily living and health-related quality of life.

Method: The study will include patients who were diagnosed with stroke for the first time according to the World Health Organization definition, who were over 18 years of age, whose general condition was stable after stroke and at least 3 months have passed since the event, among the patients followed up in the Department of Physical Medicine and Rehabilitation of Ankara University Faculty of Medicine Ibn-i Sina and Cebeci hospitals. This study will be conducted within the scope of good clinical practices and all patients will be asked to give consent to the study by reviewing the informed consent form before the study.

Inclusion Criteria:

  • Being diagnosed with stroke according to definition by the World Health Organization
  • Being over 18 years of age
  • Having had a stroke confirmed by Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI)
  • At least 3 months after stroke
  • At least stage 2 according to the Functional Ambulation Classification
  • Agreed to participate in the study and signed the informed consent form

Exclusion Criteria:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being diagnosed with stroke according to definition by the World Health Organization
  • •Being over 18 years of age
  • •Having had a stroke confirmed by Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI)
  • •At least 3 months after stroke
  • •At least stage 2 according to the Functional Ambulation Classification
  • •Agreed to participate in the study and signed the informed consent form

排除标准

  • •Previous history of stroke
  • •Communication problems due to reasons such as aphasia and dementia
  • •Patients who are illiterate
  • •Cognitive functional impairment who cannot take commands (MMSE<24)
  • •Dİagnoses such as cancer, heart failure, liver failure, renal failure that may cause fatigue
  • •Signs of systemic infection
  • •History of subarachnoid hemorrhage

结局指标

主要结局

Fatigue Severity Scale

时间窗: Baseline

The Fatigue Severity Scale was first used in 1989 by Krupp et al. to assess fatigue in patients with Multiple Sclerosis and Systemic Lupus Erythematosus. In stroke, a validity and reliability study was conducted for the first time by Nadarajah et al. in 2017. In our country, a validity and reliability study was conducted in stroke patients by Özyemişçi-Taşkıran et al. in 2019. The FSS is a self-report questionnaire that measures the impact and severity of fatigue in daily life. The FSS consists of 9 items about fatigue scored on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score is the arithmetic mean of the 9 item scores. The lowest score is 9 points and the highest is 63 points. A total score of 36 points or an average score of 4 or more means that the fatigue is pathological fatigue. The higher the FSS score, the greater the impact of fatigue on daily life. Patients are assessed by asking questions according to their fatigue in the last week.

Visual Analog Scale-Fatigue

时间窗: Baseline

Visual Analog Scale-Fatigue (VAS-Fatigue): The Visual Analog Scale is a 10 cm horizontal line with a legend at each end and is commonly used to measure pain levels. The VAS has been modified and renamed VAS-F to measure pathologic fatigue in cancer. One end of the line (0) indicates no fatigue and the other end (10) indicates unbearable fatigue. The patient will be asked to mark the level of fatigue felt during the last 1 week on a 10 cm line. The possible score will be between 0 and 10, with a higher score indicating a high degree of fatigue.

次要结局

  • Visual Analog Scale-Pain(Baseline)
  • Hospital Anxiety and Depression Scale(Baseline)
  • Athens Insomnia Scale(Baseline)
  • Brunnstrom Motor Recovery Staging(Baseline)
  • Mini Mental State Examination(Baseline)
  • Montreal Cognitive Assessment(Baseline)
  • Modified Ashworth Scale(Baseline)
  • 6 Minute Walk Test(Baseline)
  • Functional Ambulation Classification(Baseline)
  • Modified Barthel Index(Baseline)
  • Stroke Impact Scale Version 3.0(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe A Küçükdeveci, MD

Clinical Professor

Ankara University

研究点 (1)

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