Frailty and Assocciated Factors in Sarcopenia

July 11, 2025 updated by: METEHAN YANA, Karabuk University

The Level of Frailty in Individuals Diagnosed With Primary Sarcopenia; Balance, Fall Risk and Impact on Kinesiophobia

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

68

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

      • Karabük, Turkey, 78000
        • Karabuk University

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

Non-Probability Sample

Study Population

Patients with sarcopenia included in this study.

Description

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

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
Sarcopenia
According to EWGSOP2 criteria; individuals diagnosed with sarcopenia were included in the study by evaluating low muscle strength, low muscle quantity or quality, and low physical performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty
Time Frame: Baseline
Frailty will be assessed with the Edmonton Frailty Scale. It is scored between 0-17. Frailty increases as the score increases. 0-4 points: Not frail, 5-6 points: Mildly frail, 7-8 points: Moderately frail, 9-17 points: Severely frail.
Baseline
Risk of falling
Time Frame: Baseline
Fall risk will be assessed with the Denn Fall Risk Assessment Scale. The total score is generally: 0-3: Low risk, 4-6: Medium risk, 7 and above: High risk.
Baseline
Kinesiophobia
Time Frame: Baseline
The Tampa Kinesiophobia Scale will be used to assess kinesiophobia. Total score: 17-68. Higher scores indicate greater kinesiophobia (fear of movement).
Baseline
Balance
Time Frame: Baseline
Balance will be assessed with a posturography device.
Baseline

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Metehan Yana, Karabuk University
  • Principal Investigator: Ecem Çoroğlu, BD, Karabuk University

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.

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)

June 1, 2024

Primary Completion (Actual)

May 20, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

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

product manufactured in and exported from the U.S.

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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