Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255145
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2023-10-14
Brief Title:
Assessment of Body Composition Fatigue Mobility and Functional Status in Post-Stroke Individuals
Sponsor:
Pamukkale University
Organization:
Pamukkale University
Study Overview
Official Title:
Assessment of Body Composition Fatigue Mobility and Functional Status in Post-Stroke Individuals
Status:
COMPLETED
Status Verified Date:
2024-02
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:
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
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 disability¹ In Turkey the incidence of stroke was estimated as 125345 154 per hundred thousand the prevalence as 1080380 13 percent the mortality rate due to stroke as 48947 people and the number of years of life lost due to stroke-related deathdisability as 993082 years2Approximately 795000 people have a stroke in the United States of America every year and 185000 of them relapse3 In 2016 stroke was responsible for approximately 55 million deaths and 1164 million years of quality of life loss with a significant impact on the economy4 Post-stroke dysphagia visual-spatial disorientation gastrointestinal system disorders depression and increased catabolic process lead to malnutrition5 In addition to hormonal changes and immobilization fat mass increases while lean body mass decreases in individuals with stroke IVS6 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 mass57 Additionally the study by Li et al concluded that muscle loss after stroke is also accompanied by an increase in intramuscular fat and bone loss8 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 IVS9 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 symptoms10 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 levels1112 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
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