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

Body Composition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06255145
• Other study ID #: PamukkaleUniversityRC
• Status: Completed
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: July 5, 2022

Study information

• Verified date: February 2024
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 5, 2022
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Composition
• Cerebrovascular Stroke
• Stroke

Intervention

Device:
• Bioelectrical Impedance Analysis
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.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioelectrical Impedance Analysis	body weight	12 week
Primary	Bioelectrical Impedance Analysis	body fat percentage	12 week
Primary	Bioelectrical Impedance Analysis	muscle percentage	12 week
Primary	Bioelectrical Impedance Analysis	total water percentage	12 week
Primary	Bioelectrical Impedance Analysis	visceral fat amount	12 week
Primary	Bioelectrical Impedance Analysis	total bone mass	12 week
Secondary	Fatigue Severity Scale	fatique. Minimum score is 9 and maximum score is 63. Scores of 36 or more represent severe fatigue. Scale score is the mean value of the nine items. When the total score is below 4, it is considered as "not tired" and when it is above 4, it is considered as "tired".	12 week
Secondary	Rivermead Mobility Index	mobility.Total score is between 0-15. The score of 15 means that there is no problem in mobility, while a score of 14 and below means that there is a problem in mobility.	12 week
Secondary	Functional Independence Scale	functional status.It consists of 18 items under six headings: self-care, sphincter control, transfer, displacement, communication and social perception. Every item is scored between 1-7 (1 point: fully dependent, 7 points: fully independent). It is possible to get a minimum score of 18 and a maximum score of 126.	12 week

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