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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06277193
• Other study ID #: KonyaBeyhekimTRH
• Status: Completed
• Start date: November 3, 2020
• Est. completion date: September 28, 2023

Study information

• Verified date: February 2024
• Source: Konya Beyhekim Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: September 28, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Diagnostic Test:
• valuation of balance status, fear of falling and risk of falling in patients non-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.
• Evaluation of balance status, fear of falling and risk of falling in patients with probable 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.
• Evaluation of balance status, fear of falling and risk of falling in patients with 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.
• Evaluation of balance status, fear of falling and risk of falling in patients with 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.

Locations

Country	Name	City	State
Turkey	Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic	Selçuklu	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Beyhekim Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (18)

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Alkan S. 65 yas ve üstü bireylerde D vitamini düzeyi ile düsme riski arasindaki iliski. 2009.

Batsis JA, Buscemi S. Sarcopenia, sarcopenic obesity and insulin resistance. Medical Complications of Type 2 Diabetes: IntechOpen; 2011. p. 233-56

Carpenter CR. Evidence-based emergency medicine/systematic review abstract. Preventing falls in community-dwelling older adults. Ann Emerg Med. 2010 Mar;55(3):296-8. doi: 10.1016/j.annemergmed.2009.06.014. Epub 2009 Jul 17. No abstract available. — View Citation

Cawthon PM, Fox KM, Gandra SR, Delmonico MJ, Chiou CF, Anthony MS, Sewall A, Goodpaster B, Satterfield S, Cummings SR, Harris TB; Health, Aging and Body Composition Study. Do muscle mass, muscle density, strength, and physical function similarly influence risk of hospitalization in older adults? J Am Geriatr Soc. 2009 Aug;57(8):1411-9. doi: 10.1111/j.1532-5415.2009.02366.x. — View Citation

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Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13. — View Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. Erratum In: Age Ageing. 2019 Jul 1;48(4):601. — View Citation

Cruz-Jentoft AJ, Landi F, Schneider SM, Zuniga C, Arai H, Boirie Y, Chen LK, Fielding RA, Martin FC, Michel JP, Sieber C, Stout JR, Studenski SA, Vellas B, Woo J, Zamboni M, Cederholm T. Prevalence of and interventions for sarcopenia in ageing adults: a systematic review. Report of the International Sarcopenia Initiative (EWGSOP and IWGS). Age Ageing. 2014 Nov;43(6):748-59. doi: 10.1093/ageing/afu115. Epub 2014 Sep 21. — View Citation

Metter EJ, Conwit R, Tobin J, Fozard JL. Age-associated loss of power and strength in the upper extremities in women and men. J Gerontol A Biol Sci Med Sci. 1997 Sep;52(5):B267-76. doi: 10.1093/gerona/52a.5.b267. — View Citation

Oh-Park M, Xue X, Holtzer R, Verghese J. Transient versus persistent fear of falling in community-dwelling older adults: incidence and risk factors. J Am Geriatr Soc. 2011 Jul;59(7):1225-31. doi: 10.1111/j.1532-5415.2011.03475.x. Epub 2011 Jun 30. — View Citation

Rolland Y, Lauwers-Cances V, Cournot M, Nourhashemi F, Reynish W, Riviere D, Vellas B, Grandjean H. Sarcopenia, calf circumference, and physical function of elderly women: a cross-sectional study. J Am Geriatr Soc. 2003 Aug;51(8):1120-4. doi: 10.1046/j.1532-5415.2003.51362.x. — View Citation

SAHIN G, SEKER H, YESILIRMAK M, ÇADIR A. Denge diski egzersizlerinin dinamik denge ve durus kontrolü üzerindeki etkisinin incelenmesi. Spor ve performans arastirmalari dergisi. 2015;6(1):50-7.

Schepens S, Sen A, Painter JA, Murphy SL. Relationship between fall-related efficacy and activity engagement in community-dwelling older adults: a meta-analytic review. Am J Occup Ther. 2012 Mar-Apr;66(2):137-48. doi: 10.5014/ajot.2012.001156. — View Citation

Stel VS, Smit JH, Pluijm SM, Lips P. Balance and mobility performance as treatable risk factors for recurrent falling in older persons. J Clin Epidemiol. 2003 Jul;56(7):659-68. doi: 10.1016/s0895-4356(03)00082-9. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sociodemographic data	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.
Primary	Berg Balance Scale(BBS)	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.
Primary	Falls Efficacy Scale (FES)	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.
Primary	Balance and Gait Assessment Scale	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	Biochemical data	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.
Secondary	Co-morbidities	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.
Secondary	Number of drugs	Medications used due to comorbidities were questioned.	During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Secondary	Basic activities of daily living (Katz)	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.
Secondary	Instrumental activities of living (Lawton-Brody; IADL)	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.
Secondary	Mini-nutritional evaluation (MNA-Short form)	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.
Secondary	Mini-mental state assessment (MMSE)	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.
Secondary	Yesavage Geriatric Depression Scale Short Form (GDS-SF)	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.
Secondary	FRAIL fragility index	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.
Secondary	Short physical performance battery (SPPB)	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.
Secondary	Timed up and go test (TUG)	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.
Secondary	The Tampa Scale for Kinesiophobia (TSK)	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.