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OpenTrials
Completed

NCT Number: NCT06931964

Frailty and Assocciated Factors in Sarcopenia

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.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karabük University

Karabük, 78000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. Balance

    Time frame: Baseline

    Balance will be assessed with a posturography device.

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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