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

February 2, 2024 updated by: Raziye ÇELİK, Pamukkale University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20160
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

Other Names:
  • Fatigue Severity Scale
  • Rivermead Mobility Index
  • Functional Independence Scale
Active Comparator: 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.
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.

Other Names:
  • Fatigue Severity Scale
  • Rivermead Mobility Index
  • Functional Independence Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioelectrical Impedance Analysis
Time Frame: 12 week
body weight
12 week
Bioelectrical Impedance Analysis
Time Frame: 12 week
body fat percentage
12 week
Bioelectrical Impedance Analysis
Time Frame: 12 week
muscle percentage
12 week
Bioelectrical Impedance Analysis
Time Frame: 12 week
total water percentage
12 week
Bioelectrical Impedance Analysis
Time Frame: 12 week
visceral fat amount
12 week
Bioelectrical Impedance Analysis
Time Frame: 12 week
total bone mass
12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Severity Scale
Time Frame: 12 week
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
Rivermead Mobility Index
Time Frame: 12 week
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
Functional Independence Scale
Time Frame: 12 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Raziye Çelik, PT., Pamukkale University
  • Study Director: Emre Baskan, Assoc Prof., Pamukkale University
  • Study Director: Aziz Dengiz, PT Phd, Muş Alparslan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2021

Primary Completion (Actual)

June 5, 2022

Study Completion (Actual)

July 5, 2022

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Estimated)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PamukkaleUniversityRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known whether there will be a plan to roll out IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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