Clinical trial NCT06931964: Frailty and Assocciated Factors in Sarcopenia
Official title: The Level of Frailty in Individuals Diagnosed With Primary Sarcopenia; Balance, Fall Risk and Impact on Kinesiophobia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 68
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sarcopenia included in this study.

Brief summary: Primary sarcopenia is a condition that occurs with the aging process and is characterized by symptoms such as decreased muscle mass, impaired muscle function and decreased physical strength. The decrease in muscle mass can lead to a decrease in physical strength, balance and mobility, making older people more prone to frailty and falls, which can lead to a fear of falling. Although there are few studies on sarcopenia in the literature, the level of frailty in sarcopenia is related to balance, falls risk and kinesiophobia in sarcopenia.

Our aim in the study was to measure frailty in elderly individuals diagnosed with sarcopenia and to determine the level of frailty.

to evaluate the effect of sarcopenia on fall risk, balance and kinesiophobia and to evaluate the effect of sarcopenia on fall risk, balance and kinesiophobia according to the results of the evaluation and new rehabilitation programs on frailty, falls, kinesiophobia and balance resulting from sarcopenia and to be the basic data for the programs to be created.

Detailed description: Primary sarcopenia is a condition that occurs with the aging process and is characterized by symptoms such as decreased muscle mass, impaired muscle function and decreased physical strength. The decrease in muscle mass can lead to a decrease in physical strength, balance and mobility, making older people more prone to frailty and falls, which can lead to a fear of falling. Recent studies have shown that sarcopenia is closely related to frailty. Frailty is a clinical syndrome characterized by decreased strength, endurance and physiological function, including dysregulation of immune, endocrine, stress and energy regulation systems, which can make individuals more prone to physical dysfunction, loss of balance and falls. Sarcopenia can cause balance problems as it leads to muscle weakness and loss. Lack of balance puts individuals at risk of falling while performing activities of daily living increases. The risk of falling is a major concern for individuals with sarcopenia. Factors such as muscle weakness, poor balance and coordination increase the risk of falls. Kinesiophobia is frequently observed in individuals with sarcopenia. Kinesiophobia refers to the fear or avoidance of movement. Sarcopenia can limit individuals' mobility and they may develop kinesiophobia due to pain while performing daily activities or fear of falling. Kinesiophobia can limit individuals' active lifestyle and further reduce their physical functioning. As a result, the level of frailty in individuals with sarcopenia may have a negative impact on balance, fall risk and kinesiophobia. There is no study in the literature that includes the effect of frailty level on balance, fall risk and kinesiophobia in primary sarcopenia. With this study, the investigators aim to fill this gap in the literature by examining the effect of frailty level on balance, fall risk and kinesiophobia. As a common effect, the investigators think that the results of our study can be used in rehabilitation programs aiming to improve functional levels in individuals diagnosed with primary sarcopenia. It will contribute to the correct evaluation of activity and participation limitations, determination of priorities, selection of the right activity in treatment approaches, and more effective results when adapted with technology-supported approaches.

Eligibility criteria: Inclusion criteria:

1. Volunteering to participate in the study
2. 65 years of age or older
3. Being diagnosed with primary sarcopenia by a specialist
4. To have the cooperation to perform the measurements

Exclusion criteria:

1. Having a disease that will affect balance (vertigo etc.)
2. Not volunteering to participate in the study
3. History of trauma within the last six months (fracture, soft tissue injury, etc.)
4. Having undergone lower extremity surgery

Primary outcomes:
measure: Frailty
timeFrame: Baseline
measure: Risk of falling
timeFrame: Baseline
measure: Kinesiophobia
timeFrame: Baseline
measure: Balance
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabük University
Study officials:
affiliation: Karabuk University
name: Metehan Yana
role: PRINCIPAL_INVESTIGATOR
affiliation: Karabuk University
name: Ecem Çoroğlu, BD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alvarez-Bustos A, Carnicero-Carreno JA, Davies B, Garcia-Garcia FJ, Rodriguez-Artalejo F, Rodriguez-Manas L, Alonso-Bouzon C. Role of sarcopenia in the frailty transitions in older adults: a population-based cohort study. J Cachexia Sarcopenia Muscle. 2022 Oct;13(5):2352-2360. doi: 10.1002/jcsm.13055. Epub 2022 Jul 28.
citation: Ye L, Liang R, Liu X, Li J, Yue J, Zhang X. Frailty and sarcopenia: A bibliometric analysis of their association and potential targets for intervention. Ageing Res Rev. 2023 Dec;92:102111. doi: 10.1016/j.arr.2023.102111. Epub 2023 Oct 29.