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临床试验/NCT06255145
NCT06255145已完成不适用

Assessment of Body Composition, Fatigue, Mobility and Functional Status in Post-Stroke Individuals

Pamukkale University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Bioelectrical Impedance Analysis

研究概览

简要总结

The goal of this randomized controlled trial is to evaluate body composition, fatigue, mobility level, functional status in with stroke individuals. The main questions it aims to answer are:

How is body composition affected in individuals with stroke? How is the level of fatigue affected in individuals with stroke? How is the mobility level affected in individuals with stroke? How is functional status affected in individuals with stroke? In this study, we included 21 patients with stroke and 21 healthy controls. The body composition of the participants was evaluated by Bioelectrical Impedance Analysis (BIA), fatigue level by Fatigue Severity Scale (FSS), mobility level by Rivermead Mobility Index (RMI), and functional status by Functional Independence Scale (FIM).

详细描述

As defined by the World Health Organization, stroke is "a clinical condition that has no apparent cause other than vascular causes, lasts for 24 hours or longer, or may result in death, and is characterized by sudden focal (or global) disturbances in cerebral function. It is the third leading cause of mortality in the world after cardiovascular diseases and cancer, and ranks first in terms of causing disability.¹ In Turkey, the incidence of stroke was estimated as 125,345 (154 per hundred thousand), the prevalence as 1,080,380 (1.3 percent), the mortality rate due to stroke as 48,947 people and the number of years of life lost due to stroke-related death/disability as 993,082 years.2Approximately 795000 people have a stroke in the United States of America every year and 185000 of them relapse.3 In 2016, stroke was responsible for approximately 5.5 million deaths and 116.4 million years of quality of life loss, with a significant impact on the economy.4 Post-stroke dysphagia, visual-spatial disorientation, gastrointestinal system disorders, depression, and increased catabolic process lead to malnutrition.5 In addition to hormonal changes and immobilization, fat mass increases while lean body mass decreases in individuals with stroke (IVS).6 Besides, following stroke, factors such as inadequate calorie and macronutrient intake, denervation, disuse, spasticity, and inflammation may come together to cause sarcopenia and thereby an increase in fat mass.5,7 Additionally, the study by Li et al. concluded that muscle loss after stroke is also accompanied by an increase in intramuscular fat and bone loss.8 In IVS, loss of muscle mass causes fatigue, general weakness and lack of energy. In one study, it was stated that skeletal muscle mass should be increased to reduce fatigue in IVS.9 Fatigue is a subjectively reported lack of physical and mental energy that negatively affects daily life activities. Among stroke survivors, 40% identified fatigue as one of the worst symptoms.10 IVS have gait and balance disorders due to motor, visual-perceptual, sensory problems, spasticity, paralysis, muscle atrophy, increase in fat mass, fatigue, movement limitations, proprioceptive sensory loss and impairments in cognitive functions. This situation can negatively affect the functional status of individuals by reducing their mobility levels.11,12 In stroke rehabilitation, it is important to identify the fat mass in individuals with stroke, to determine the loss of muscle mass in parallel, to determine in which regions the fat mass level increases more significantly, and to compare the fatigue and functional losses that may occur with this increase with healthy individuals in the same age group. In the literature, we did not find any study that evaluated body composition changes, fatigue, mobility and functional status together in IVS. The present study is significant in terms of examining the body composition of IVS in detail and evaluating the extent to which body composition parameters, fatigue, mobility and functional independence levels differ when compared with healthy controls. The purpose of our study is to compare body composition, fatigue, mobility and functional status in stroke patients with healthy subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Bioelectrical Impedance Analysis

时间窗: 12 week

body weight

次要结局

  • Fatigue Severity Scale(12 week)
  • Rivermead Mobility Index(12 week)
  • Functional Independence Scale(12 week)

研究者

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

Raziye ÇELİK

Principal Investigator physiotherapist

Pamukkale University

研究点 (2)

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