Assessment of Body Composition, Fatigue, Mobility and Functional Status in Post-Stroke Individuals
Condition: Cerebrovascular Stroke; Body Composition
MeSH terms: Stroke
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Bioelectrical Impedance Analysis
Intervention type(s): Device
Intervention description(s): Bioelectrical Impedance Analysis Beurer BF 1000 Super Precision device was used to measure the body composition of the participants. Operating on the principle of BIA, the device allows the body composition to be evaluated by giving an imperceptible electric current to the body.
Fatigue Severity Scale (FSS) Fatigue Severity Scale (FSS) was used to measure participants' fatigue levels. Rivermead Mobility Index Rivermead Mobility Index (RMI) was used to assess the mobility levels of the participants.
Functional Independence Measure Functional Independence Measure (FIM) was used to evaluate the functional status of the participants.
Other intervention name(s): Fatigue Severity Scale; Rivermead Mobility Index; Functional Independence Scale
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Based on the results of the power analysis, it was calculated that 80% power could be obtained at 95% confidence level when at least 42 people (21 people for each group) were included in the study all participants, body composition evaluation was carried out with the Beurer BF 1000 Super Precision device using the Bioelectrical Impedance Analysis principle, fatigue evaluation was carried out with the Fatigue Severity Scale, mobility evaluation was carried out with the Rivermead Mobility Index, and functional status evaluation was carried out with the Functional Independence Scale.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Stroke; Body Composition; Fatique; Mobility; Functional Status