NCT06931964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

February 11, 2025

Last Update Submit

July 11, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Frailty

    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

    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

    The Tampa Kinesiophobia Scale will be used to assess kinesiophobia. Total score: 17-68. Higher scores indicate greater kinesiophobia (fear of movement).

    Baseline

  • Balance

    Balance will be assessed with a posturography device.

    Baseline

Study Arms (1)

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.

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with sarcopenia included in this study.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabük University

Karabük, 78000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 38031836BACKGROUND
  • 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.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Metehan Yana

    Karabuk University

    PRINCIPAL INVESTIGATOR
  • Ecem Çoroğlu, BD

    Karabuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor, PhD

Study Record Dates

First Submitted

February 11, 2025

First Posted

April 17, 2025

Study Start

June 1, 2024

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations