SarcopeniaNCT06931964
Frailty and Assocciated Factors in Sarcopenia
An observational study of Sarcopenia, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 20 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients with sarcopenia included in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Kinesiophobia
The Tampa Kinesiophobia Scale will be used to assess kinesiophobia. Total score: 17-68. Higher scores indicate greater kinesiophobia (fear of movement).
Measured: Baseline
Balance
Balance will be assessed with a posturography device.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Jun 2024
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, METEHAN YANA, Karabuk University
- Investigators
- Metehan Yana, Principal investigator, Karabuk UniversityEcem Çoroğlu, BD, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931964
- Sponsor's protocol ID
- Karabuk 001
- Status last verified
- Jul 2025
- First submitted
- 11 Feb 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38031836Alvarez-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.
PubMed 35903871
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Level of Frailty in Individuals Diagnosed With Primary Sarcopenia; Balance, Fall Risk and Impact on Kinesiophobia
- ClinicalTrials.gov ID
- NCT06931964
- Acronym / sponsor ID
- Karabuk 001
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients with sarcopenia included in this study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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).
Balance
Time frame: Baseline
Balance will be assessed with a posturography device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Background: PubMed 38031836Ye 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.
- Results publication: PubMed 35903871Alvarez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Metehan Yana principal investigator
Karabuk University
Ecem Çoroğlu, BD principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06931964, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.