Clinical trial NCT06255145: Assessment of Body Composition, Fatigue, Mobility and Functional Status in Post-Stroke Individuals
Official title: Assessment of Body Composition, Fatigue, Mobility and Functional Status in Post-Stroke Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Stroke
Body Composition
Keywords: Stroke
Body Composition
Fatique
Mobility
Functional Status
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: OTHER

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).

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.

Eligibility criteria: Inclusion criteria for individuals with stroke:

* Being between the ages of 18-65
* Volunteering to participate in the study
* Having a score of 25 or above on the Mini Mental Test
* Getting a score between 0-3 on the Modified Rankin Scale

Exclusion criteria for individuals with stroke:

* Having cardiac insufficiency
* Being morbid obesity
* Having pacemaker
* Being pregnant

Inclusion criteria for healty individuals:

* Being between the ages of 30-65
* Volunteering to participate in the study
* Not having any neurological, orthopedic, rheumatologic and metabolic problems
* Having a score of 25 or above on the Mini Mental Test

Exclusion criteria for healty individuals:

* Participating in any fat burning diet program
* Exercising regularly
* Being pregnant

Primary outcomes:
measure: Bioelectrical Impedance Analysis
timeFrame: 12 week
measure: Bioelectrical Impedance Analysis
timeFrame: 12 week
measure: Bioelectrical Impedance Analysis
timeFrame: 12 week
measure: Bioelectrical Impedance Analysis
timeFrame: 12 week
measure: Bioelectrical Impedance Analysis
timeFrame: 12 week
measure: Bioelectrical Impedance Analysis
timeFrame: 12 week
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: 12 week
measure: Rivermead Mobility Index
timeFrame: 12 week
measure: Functional Independence Scale
timeFrame: 12 week
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Raziye Çelik, PT.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Emre Baskan, Assoc Prof.
role: STUDY_DIRECTOR
affiliation: Muş Alparslan University
name: Aziz Dengiz, PT Phd
role: STUDY_DIRECTOR
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