Investigation of the Relationship Between Sarcopenia and Balance, Fear of Falling and Fall Risk in Older Female Patients

February 17, 2024 updated by: Fatih Güreş, Konya Beyhekim Training and Research Hospital
This study (study type: cross-sectional) aims to investigate the relationship of sarcopenia level with balance, fear of falling and risk of falling in the elderly female population. In the first stage, 166 participants were divided into two groups: sarcopenia and non-sarcopenia. Afterwards, they were categorized according to sarcopenia level (probable sarcopenia group, sarcopenia group, severe sarcopenia group, group without sarcopenia) and comparisons were made between these subgroups. Then, they were evaluated with various scales and tests (in terms of balance, fear of falling and risk of falling).

Study Overview

Detailed Description

The world population is experiencing an aging trend accompanied by declines in fertility and mortality rates. This aging process varies among countries and regions. The aging of societies leads to an increase in health and socioeconomic problems. Sarcopenia is just one of the problems that arise with aging.

Sarcopenia is defined as a progressive syndrome associated with a general loss of muscle mass and strength, leading to a decrease in physical function, deterioration in quality of life, and even adverse outcomes such as death. Although sarcopenia is primarily defined as a syndrome associated with the elderly population, it can also be observed in non-elderly individuals with other diseases or conditions. Therefore, due to its higher prevalence in the elderly population, it can also be referred to as a geriatric syndrome.

The prevalence of sarcopenia varies depending on the measurement methods used to assess muscle mass, muscle strength, and muscle performance, as well as the population studied. The frequency of sarcopenia can range from 8% to 40% in populations aged 60 and over. Muscle mass decreases linearly in both men and women after the age of 40. These losses in muscle mass continue at a rate of 8% per decade up to the age of 70 and increase to 15% in the subsequent decades. Total loss can reach up to 50% in the eighth decade.

The etiology of sarcopenia is multifactorial. Aging, certain chronic diseases, immobility, sedentary lifestyle, and nutritional deficiencies can contribute to sarcopenia. While sarcopenia can sometimes be attributed to a single cause, in most cases, a single cause cannot be identified. Sarcopenia can generally be classified into two main categories: primary and secondary. Primary sarcopenia is solely associated with the aging process, while secondary sarcopenia develops due to one or more causes (such as immobility, comorbidities, nutrition). However, it may not always be possible to make a clear distinction between primary and secondary sarcopenia.

Various imaging methods such as computerized tomography (CT), magnetic resonance imaging (MRI), or dual-energy X-ray absorptiometry (DEXA) can be used to determine muscle mass in the diagnosis of sarcopenia, while anthropometric measurements such as bioimpedance analysis or upper mid-arm circumference and calf circumference may also be applied. Muscle strength is generally measured using a hand dynamometer, while methods such as walking tests, sit-to-stand tests, or stair climbing tests can be used to assess muscle performance.

Individuals who have results below critical values in muscle strength measurement but have normal muscle mass, muscle quality, and physical performance values are defined as probable sarcopenia. If there is also low muscle mass in addition to decreased muscle strength, this condition is classified as sarcopenia. If there is a decrease in muscle mass or quality along with decreased muscle strength and physical performance, this condition can be classified as severe sarcopenia.

Balance is an expression of postural adaptation to changes in the center of gravity during rest or movement. Factors that maintain balance are the integration of vestibular, proprioceptive, and visual data within the central nervous system and coordinated muscle activity resulting from voluntary or involuntary reflex activity. Disruption of balance predisposes to falls. A fall is a condition that usually results in an unwanted change in position, without a significant intrinsic event, strong external force, or intentional movement, usually on the ground or at a lower level. It can also be defined as an uncorrectable change in position.

One of the psychological consequences of falling is fear of falling. This is defined as an anxiety condition that leads to avoidance of physical activity after a fall. This condition is often accompanied by anxiety and loss of confidence. Fear of falling may decrease over time or become continuous. Previous fall events, advanced age, being female, vision problems, depressive mood, polypharmacy, and balance disorders can be among the risk factors for fear of falling.

Studies have found that sarcopenia is associated with many diseases, reduces quality of life, increases dependency, affects mortality, and increases hospitalizations. However, studies investigating the relationship between balance, risk of falling, fear of falling, and sarcopenia are limited in the literature. This study aims to investigate the relationship between the level of sarcopenia and balance, fear of falling, and risk of falling in an elderly female population.

Study Type

Observational

Enrollment (Actual)

166

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

    • Konya
      • Selçuklu, Konya, Turkey
        • Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic

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

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

208 patients who applied to the outpatient clinic were examined for eligibility for the study. During the detailed evaluation process, patients who did not meet the exclusion criteria (communication problems, etc.) and did not want to participate in the study were excluded from the study. Detailed histories were taken from the remaining 166 participants and physical examinations were performed.

Description

Inclusion Criteria:

  1. Being over 60 years old
  2. Being a woman

Exclusion Criteria:

  1. Those under 60 years of age
  2. Male ones
  3. Hand deformities
  4. Advanced knee osteoarthritis
  5. Advanced hand osteoarthritis
  6. Advanced osteoarthritis in the waist and hip area
  7. History of Carpal Tunnel Syndrome
  8. Communication disorders
  9. Muscle diseases
  10. Root compressions
  11. History of upper and lower extremity spine surgery, prostheses and previous fracture history
  12. Those with advanced kyphosis and scoliosis
  13. Those with serious neck problems
  14. Lumbar spinal stenosis
  15. Those with decompensated heart, liver and kidney failure
  16. Those who have any disease (neurological, orthopedic, metabolic, etc.) that causes balance disorders
  17. Those who use medication that may cause balance disorders
  18. Those with severe hearing and vision impairment
  19. History of antidepressant, anticholinergic, benzodiazepine and anxiolytic use in the last 3 months
  20. Those with major psychiatric illness
  21. Those who use alcohol regularly
  22. Patients with pacemakers
  23. Those with immobility, those whose mobilization is limited for some reason

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-sarcopenia group
The diagnosis of sarcopenia was determined using EWGSOP2(The European Working Group on Sarcopenia in Older People) criteria. To evaluate walking speed, muscle strength and muscle mass, hand grip test, bioimpedance and 4-meter walking test were performed on each patient, respectively. Those who had results above the critical values determined in muscle strength measurement according to criteria were defined as the group without sarcopenia.
Daily living activities, frailty, physical performance, balance status, risk of falling, fear of falling, nutritional status, and mental status were evaluated with various scales.
Probable sarcopenia group
Individuals with results below the critical values determined in muscle strength measurement were defined as the probable sarcopenia group if their muscle mass and physical performance values were normal.
Daily living activities, frailty, physical performance, balance status, risk of falling, fear of falling, nutritional status, and mental status were evaluated with various scales.
Sarcopenia group
If low muscle mass is present in addition to the decrease in muscle strength, this condition is classified as sarcopenia.
Daily living activities, frailty, physical performance, balance status, risk of falling, fear of falling, nutritional status, and mental status were evaluated with various scales.
Severe sarcopenia group
If there is a decrease in muscle mass and physical performance along with muscle strength, this condition can be classified as severe sarcopenia.
Daily living activities, frailty, physical performance, balance status, risk of falling, fear of falling, nutritional status, and mental status were evaluated with various scales.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic data
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
A form was created to determine the sociodemographic characteristics of the patients. In addition, data on the number of falls and fractures in the last year was also obtained in this form.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Berg Balance Scale(BBS)
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
The Berg balance scale was initially developed to evaluate postural control and is now widely used in many fields. Scoring is done on a 5-point scale that evaluates whether the patient can perform the task safely and independently within a certain period of time. 0 points are given for unrealizable performances and 4 points are given for normal performances. The points given are added together to obtain the maximum score. 0-20 points indicate high fall risk, 21-40 points indicate medium fall risk, 41-56 points indicate low fall risk.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Falls Efficacy Scale (FES)
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Developed based on low perceived self-efficacy, FES is a reliable and valid method to measure fear of falling. Such as taking a bath, taking a shower, reaching shelves, walking around the house, preparing meals without carrying heavy or hot objects, getting in and out of bed, answering the door or telephone ring, sitting on a chair and getting up, dressing and undressing, going to the toilet and leaving the toilet, personal care. Patients are asked to rate their daily living activities. The points given are evaluated between "1 point I trust very much" and "10 points I do not trust at all", the scores between 0 and 10 are summed and the resulting score is recorded.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Balance and Gait Assessment Scale
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
This scale is an important tool to evaluate the individual's functional status and daily living activities. The scale consists of a maximum of 16 points for balance and a maximum of 12 points for walking, for a total of 28 points. Individuals who score 26 or below on the scale are thought to have a problem; For those with scores of 19 or below, it is observed that the risk of self-falling increases fivefold compared to normal individuals.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical data
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
The most current biochemical data in the hospital system within the last year were recorded.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Co-morbidities
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Comorbidities of the patients were recorded.(like hypertension, heart disease...etc.)
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Number of drugs
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Medications used due to comorbidities were questioned.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Basic activities of daily living (Katz)
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
The ADL Index, developed by Katz and his team in 1963, determines activities aimed at fulfilling the basic needs for the continuation of life. The ADL Index includes six questions about bathing, dressing, toileting, movement, excretion and feeding activities. Scoring is made between 0 and 6, and an increase in the score is associated with an increase in the level of independence.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Instrumental activities of living (Lawton-Brody; IADL)
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Developed by Lawton and Brody in 1969, IADL determines the instrumental daily living activities of individuals. The IADL Index includes eight questions about using the phone, preparing meals, shopping, doing daily household chores, doing laundry, taking transportation, using medications, and money management. Scoring is made between 0 and 8, and the increase in the score is related to the increase in the level of independence.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Mini-nutritional evaluation (MNA-Short form)
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Mini-nutritional assessment-short form consists of six items that have been determined to have a high correlation with conventional nutritional assessment. In this evaluation, scoring is done by looking at factors such as the change in the patient's appetite, whether there has been weight loss in the last three months, mobility, whether the patient has experienced psychological distress or acute illness in the last three months, the presence of neuropsychological problems and body mass index.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Mini-mental state assessment (MMSE)
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Folstein et al. Developed in 1975, this brief screening test is the most commonly used test for dementia screening. It consists of eleven questions and is evaluated out of 30 points. Scores between twenty-four and thirty points may reflect normal, scores between 18-23 points may reflect mild dementia, and scores of 17 points and below may reflect severe dementia. This test evaluates areas such as orientation, memory, attention, calculation, recall, language, motor function and perception, and its biggest advantage is that it can be easily and quickly applied.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Yesavage Geriatric Depression Scale Short Form (GDS-SF)
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
GDS-SF, developed by Yesavage et al. in 1983, is used to screen for depression in elderly patients. The 15-question short form, developed by Burke et al. in 1991 and proven to be valid and reliable, is preferred for its ease of use. GDS-SF is a screening test that can be applied quickly and easily. Scores of five points and above may be compatible with depression, but the patient's clinical condition should also be taken into account for a definitive assessment. This test provides an advantage in that it can be applied to patients with dementia.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
FRAIL fragility index
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
The "FRAIL Scale", developed by Morley and his team in 2012, is an evaluation tool consisting of 5 items. This scale receives a score of 0 or 1 for each item, depending on the answers given by the patients. As a result of the total scoring, those who score 0 points are classified as "non-frail", those who score 1-2 points are classified as "pre-frail", and those who score more than 2 points are classified as "frail".
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Short physical performance battery (SPPB)
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
SPPB was used to evaluate physical function. SPPB includes 3 objective tests that evaluate lower extremity function; Walking 4 meters, getting up from a chair and standing balance. The total test score ranges from 0 to 12. High scores indicate strong lower extremity function and a low risk of falling
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Timed up and go test (TUG)
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
A short, simple and reliable test used to evaluate balance function involves tasks such as getting up from a chair, walking 3 meters forward, turning 180 degrees in place, walking back to the chair and sitting down. While the person performs these tasks, time is kept with a stopwatch. There is a significant relationship between the time to complete the test and the level of functional mobility. It was observed that people who completed the test in less than 20 seconds were independent in transfer, received high scores on BBS, and achieved the required walking speed (0.5 m/sec) in society. It was determined that people who completed the test in 30 seconds or more were more dependent on their daily living activities, needed assistive devices for ambulation, and had lower scores on BBS.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
The Tampa Scale for Kinesiophobia (TSK)
Time Frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
TSK was originally developed in 1991 but was not published. This original scale was later republished in 1995 with the permission of the researchers who developed it. TSK is a 17-item scale designed to measure fear of movement-related injury. The scale includes fear-avoidance parameters in cases of injury or re-injury in work-related activities.
During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Fatih güreş, assistant doctor

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

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)

November 3, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

September 28, 2023

Study Registration Dates

First Submitted

February 10, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Estimated)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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