Clinical trial NCT06277193: Investigation of the Relationship Between Sarcopenia and Balance, Fear of Falling and Fall Risk in Older Female Patients
Official title: Investigation of the Relationship Between Sarcopenia and Balance, Fear of Falling and Fall Risk in Older Female Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: Sarcopenia
Old
Balance
Fear of falling
Falling risk
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-26
Enrollment: 166
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sociodemographic data
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Berg Balance Scale(BBS)
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Falls Efficacy Scale (FES)
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Balance and Gait Assessment Scale
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Secondary outcomes:
measure: Biochemical data
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Co-morbidities
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Number of drugs
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Basic activities of daily living (Katz)
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Instrumental activities of living (Lawton-Brody; IADL)
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Mini-nutritional evaluation (MNA-Short form)
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Mini-mental state assessment (MMSE)
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Yesavage Geriatric Depression Scale Short Form (GDS-SF)
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: FRAIL fragility index
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Short physical performance battery (SPPB)
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: Timed up and go test (TUG)
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
measure: The Tampa Scale for Kinesiophobia (TSK)
timeFrame: During the initial evaluation of the patients, their information was recorded in approximately 1 hour.
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic
state: Konya
Study officials:
affiliation: assistant doctor
name: Fatih güreş
role: PRINCIPAL_INVESTIGATOR
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