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

NCT ID: NCT06255145

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-17
• Study Completion Date: 2022-07-05

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.

Conditions

Cerebrovascular Stroke; Body Composition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental group

In 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.

Group Type: EXPERIMENTAL

Bioelectrical Impedance Analysis

Intervention Type: DEVICE

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.

Control Group

In 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.

Group Type: ACTIVE_COMPARATOR

Bioelectrical Impedance Analysis

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Fatigue Severity Scale; Rivermead Mobility Index; Functional Independence Scale

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Raziye ÇELİK

Principal Investigator physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raziye Çelik, PT.

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Emre Baskan, Assoc Prof.

Role: STUDY_DIRECTOR

Pamukkale University

Aziz Dengiz, PT Phd

Role: STUDY_DIRECTOR

Muş Alparslan University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

PamukkaleUniversityRC

Identifier Type: -

Identifier Source: org_study_id