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临床试验/NCT05758558
NCT05758558已完成不适用

Cognitive, Psychological, and Physical Functioning in Long-COVID Patients With Different Levels of Fatigue.

Hasselt University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2023年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
试验地点
1
主要终点
Fatigue severity

研究概览

简要总结

Post COVID-19 usually occurs 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Patients report a range of disabling symptoms such as fatigue, shortness of breath, cognitive impairment, memory loss and mental health and employment issues. This clinical heterogeneity complicates the identification of the appropriate needs and care.

The aim of this cross-sectional study is to identify subgroups (clusters) of post COVID patients based on clinical symptoms, demographic characteristics, levels of fatigue and physical, cognitive and psychological functioning of the individuals.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • The participant must report current persisting symptoms (such as brain fog, anxiety, shortness of breath, headaches but also others) and indicate on the Post COVID-19 Functional Status Scale that these have an impact on everyday functioning (grade 2, 3, and 4). These symptoms need to be present for more than two months.
  • Further inclusion criteria are:
  • Fatigue Severity Scale (FSS) score > 4
  • Aged over 18 years old
  • Willing to sign the digital informed consent
  • Dutch speaking and Dutch understanding
  • Be tested positive for COVID-19, i.e. by reverse transcription polymerase chain reaction (RT-PCR), computed tomography (CT) of the lungs, or symptom-based diagnosis by the general practitioner.

排除标准

  • Pregnant women
  • Pacemaker, defibrillator
  • Brain or nerve disorders
  • A copper spiral or recent bone fracture

结局指标

主要结局

Fatigue severity

时间窗: Day 1

Fatigue severity scale (FSS)

Psychological evaluation

时间窗: Day 1

Anxiety and depression Scale (HADS); MINI-S, MINI International Neuropsychiatric Interview - Simplified (Overbeek \& Schruers 2019)

Physical evaluation

时间窗: Day 1

Hand grip strength (Jamar hand dynamometer) \& Six Minute Walk Test (6MWT)

Cognitive evaluation

时间窗: Day 1

Multi-modal Evaluation of Sensory Sensitivity (MESSY); Montreal Cognitive Assessment (MoCA)

次要结局

未报告次要终点

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stef Feijen

Doctoral Assistant

Hasselt University

研究点 (1)

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