SarcopeniaNCT06277193
Investigation of the Relationship Between Sarcopenia and Balance, Fear of Falling and Fall Risk in Older Female Patients
An observational study of Sarcopenia, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- valuation of balance status, fear of falling and risk of falling in patients non-sarcopenia., Evaluation of balance status, fear of falling and risk of falling in patients with probable sarcopenia. and Evaluation of balance status, fear of falling and risk of falling in patients with sarcopenia.
- How many people
- 166 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2020to 28 Sep 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- Being over 60 years old
- Being a woman
Who cannot join
- Those under 60 years of age
- Male ones
- Hand deformities
- Advanced knee osteoarthritis
- Advanced hand osteoarthritis
- Advanced osteoarthritis in the waist and hip area
Show all 23Show fewer
- History of Carpal Tunnel Syndrome
- Communication disorders
- Muscle diseases
- Root compressions
- History of upper and lower extremity spine surgery, prostheses and previous fracture history
- Those with advanced kyphosis and scoliosis
- Those with serious neck problems
- Lumbar spinal stenosis
- Those with decompensated heart, liver and kidney failure
- Those who have any disease (neurological, orthopedic, metabolic, etc.) that causes balance disorders
- Those who use medication that may cause balance disorders
- Those with severe hearing and vision impairment
- History of antidepressant, anticholinergic, benzodiazepine and anxiolytic use in the last 3 months
- Those with major psychiatric illness
- Those who use alcohol regularly
- Patients with pacemakers
- Those with immobility, those whose mobilization is limited for some reason
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic
Selçuklu, Konya
About this study
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).
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- valuation of balance status, fear of falling and risk of falling in patients non-sarcopenia., Evaluation of balance status, fear of falling and risk of falling in patients with probable sarcopenia., Evaluation of balance status, fear of falling and risk of falling in patients with sarcopenia., Evaluation of balance status, fear of falling and risk of falling in patients with severe sarcopenia.
- Keywords
- Sarcopenia, Old, Balance, Fear of falling, Falling risk
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valuation of balance status, fear of falling and risk of falling in patients non-sarcopenia.Diagnostic test
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.Diagnostic test
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.Diagnostic test
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.Diagnostic test
Daily living activities, frailty, physical performance, balance status, risk of falling, fear of falling, nutritional status, and mental status were evaluated with various scales.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: valuation of balance status, fear of falling and risk of falling in patients non-sarcopenia. | |
| 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. Receives: Diagnostic Test: Evaluation of balance status, fear of falling and risk of falling in patients with probable sarcopenia. | |
| Sarcopenia group | If low muscle mass is present in addition to the decrease in muscle strength, this condition is classified as sarcopenia. Receives: Diagnostic Test: Evaluation of balance status, fear of falling and risk of falling in patients with sarcopenia. | |
| 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. Receives: Diagnostic Test: Evaluation of balance status, fear of falling and risk of falling in patients with severe sarcopenia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Secondary outcomes (12)
Biochemical data
The most current biochemical data in the hospital system within the last year were recorded.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Co-morbidities
Comorbidities of the patients were recorded.(like hypertension, heart disease...etc.)
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Number of drugs
Medications used due to comorbidities were questioned.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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".
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
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.
Measured: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start3 Nov 2020
- Primary completion1 Dec 2022
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 166 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatih Güreş, Konya Beyhekim Training and Research Hospital
- Investigators
- Fatih güreş, Principal investigator, assistant doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277193
- Sponsor's protocol ID
- KonyaBeyhekimTRH
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20392703Cruz-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.
PubMed 25241753Batsis JA, Buscemi S. Sarcopenia, sarcopenic obesity and insulin resistance. Medical Complications of Type 2 Diabetes: IntechOpen; 2011. p. 233-56
Abellan van Kan G. Epidemiology and consequences of sarcopenia. J Nutr Health Aging. 2009 Oct;13(8):708-12. doi: 10.1007/s12603-009-0201-z.
PubMed 19657554Metter 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.
PubMed 9310077Rolland 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.
PubMed 12890076Cruz-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.
PubMed 30312372ŞAHİN G, ŞEKER H, YEŞİLIRMAK M, ÇADIR A. Denge diski egzersizlerinin dinamik denge ve duruş kontrolü üzerindeki etkisinin incelenmesi. Spor ve performans araştırmaları dergisi. 2015;6(1):50-7.
Alkan S. 65 yaş ve üstü bireylerde D vitamini düzeyi ile düşme riski arasındaki ilişki. 2009.
Akman MN, Karataş M. Temel ve uygulanan kinezyoloji: Haberal Eğitim Vakfı; 2003.
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.
PubMed 12921935ÇINARLI T, Zeliha K. 65 Yaş Ve Üzeri Yaşlılarda Düşme Risk Ve Korkusunun Günlük Yaşam Aktiviteleri Ve Yaşam Kalitesi Üzerine Etkisi. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi. 2015;4(4):660-79.
Tinetti ME, Williams TF, Mayewski R. Fall risk index for elderly patients based on number of chronic disabilities. Am J Med. 1986 Mar;80(3):429-34. doi: 10.1016/0002-9343(86)90717-5.
PubMed 3953620Schepens 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.
PubMed 22394523Carpenter 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.
PubMed 19615786
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Sarcopenia and Balance, Fear of Falling and Fall Risk in Older Female Patients
- ClinicalTrials.gov ID
- NCT06277193
- Acronym / sponsor ID
- KonyaBeyhekimTRH
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Old, Balance, Fear of falling, Falling risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-sarcopenia group | – | Diagnostic Test: valuation of balance status, fear of falling and risk of falling in patients non-sarcopenia.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. |
| Probable sarcopenia group | – | Diagnostic Test: Evaluation of balance status, fear of falling and risk of falling in patients with probable sarcopenia.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. |
| Sarcopenia group | – | Diagnostic Test: Evaluation of balance status, fear of falling and risk of falling in patients with sarcopenia.If low muscle mass is present in addition to the decrease in muscle strength, this condition is classified as sarcopenia. |
| Severe sarcopenia group | – | Diagnostic Test: Evaluation of balance status, fear of falling and risk of falling in patients with severe sarcopenia.If there is a decrease in muscle mass and physical performance along with muscle strength, this condition can be classified as severe sarcopenia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- Being over 60 years old
- Being a woman
Key exclusion criteria (23 listed)
- Those under 60 years of age
- Male ones
- Hand deformities
- Advanced knee osteoarthritis
- Advanced hand osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Non-sarcopenia group |
| 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. | Diagnostic test | Probable sarcopenia group |
| 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. | Diagnostic test | Sarcopenia group |
| 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. | Diagnostic test | Severe sarcopenia group |
Primary outcome
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.
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.
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.
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.
12 secondary outcomes
Biochemical data
Time frame: 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.
Number of drugs
Time frame: 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.
Instrumental activities of living (Lawton-Brody; IADL)
Time frame: 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-mental state assessment (MMSE)
Time frame: 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.
FRAIL fragility index
Time frame: 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.
Timed up and go test (TUG)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 20392703Cruz-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.
- Background: PubMed 25241753Cruz-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.
- BackgroundBatsis JA, Buscemi S. Sarcopenia, sarcopenic obesity and insulin resistance. Medical Complications of Type 2 Diabetes: IntechOpen; 2011. p. 233-56
- Background: PubMed 19657554Abellan van Kan G. Epidemiology and consequences of sarcopenia. J Nutr Health Aging. 2009 Oct;13(8):708-12. doi: 10.1007/s12603-009-0201-z.
- Background: PubMed 9310077Metter 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.
- Background: PubMed 12890076Rolland 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.
- Background: PubMed 30312372Cruz-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.
- BackgroundŞAHİN G, ŞEKER H, YEŞİLIRMAK M, ÇADIR A. Denge diski egzersizlerinin dinamik denge ve duruş kontrolü üzerindeki etkisinin incelenmesi. Spor ve performans araştırmaları dergisi. 2015;6(1):50-7.
- BackgroundAlkan S. 65 yaş ve üstü bireylerde D vitamini düzeyi ile düşme riski arasındaki ilişki. 2009.
- BackgroundAkman MN, Karataş M. Temel ve uygulanan kinezyoloji: Haberal Eğitim Vakfı; 2003.
- Background: PubMed 12921935Stel 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.
- BackgroundÇINARLI T, Zeliha K. 65 Yaş Ve Üzeri Yaşlılarda Düşme Risk Ve Korkusunun Günlük Yaşam Aktiviteleri Ve Yaşam Kalitesi Üzerine Etkisi. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi. 2015;4(4):660-79.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatih güreş principal investigator
assistant doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic data (time frame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06277193, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.