GeriatricsNCT05938153
Evaluation of Metabolic Syndrome, Frailty, Locomotive Syndrome, Balance and Physical Fitness in Elderly Individuals
An observational study of Geriatrics and Fragility, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Metabolic syndrome (MetS) or syndrome X, which is increasingly prevalent in the world and in our country, is a disease that includes abdominal obesity, dyslipidemia, impaired glycemic control and hypertension components. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatrics, Fragility, Locomotor
- What is being tested?
- observational physical tests
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 20 Jan 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 years and older
- All sexes
- Older adult
Study population: Individuals aged 65 and over, 10 individuals
Who may be able to join
- Individuals aged 65 and over,
- Volunteering to participate in the research
- No cooperation and communication problems
Who cannot join
- Individuals with neurological and orthopedic problems
- Uncontrolled hypertension
- Those with cardiac disorders
- Those with cooperation and communication problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University
Kirikkale, Kırıkkale, 71450
About this study
Metabolic syndrome (MetS) or syndrome X, which is increasingly prevalent in the world and in our country, is a disease that includes abdominal obesity, dyslipidemia, impaired glycemic control and hypertension components. It causes cardiovascular events such as myocardial hypertrophy, left ventricular diastolic dysfunction, atrial dilatation and atrial fibrillation. Low levels of physical activity can be caused by a wide variety of factors including environmental and genetic factors, age, race, sarcopenia, poor eating habits, postmenopausal period and smoking history. Factors such as genetic differences, diet, physical activity, age, gender and eating habits are reported to affect the prevalence of (MetS) and its components. Frailty is also emerging as a major issue for the elderly due to its debilitating effects on health outcomes. Frailty is a geriatric syndrome characterized by a gradual decrease in homeostatic tolerance and physiological reserve following exposure to stressors. Frailty predisposes older people to falls, delirium, hospitalizations and even death and is therefore considered a crucial transition between healthy ageing and disability. As a result of aging, degenerative changes in the central and peripheral vestibular system have been found. With age, the ability to regulate movement is impaired as a result of insufficient information in any of the sensory receptors or any disorder affecting the processing of these messages. This directly affects balance and postural control, leading to an increased risk of falls. In the light of the results of the studies in the literature, degenerative changes are observed in many systems in geriatric individuals and while the incidence of metabolic syndrome in these individuals is high, the number of studies evaluating their effects is not sufficient. Based on these deficiencies, it is aimed to examine metabolic syndrome, frailty, locomotive syndrome, balance and physical fitness in elderly individuals.
- Conditions
- Geriatrics, Fragility, Locomotor, Physical Fitness, Balance
- Being tested
- observational physical tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational physical testsOther
Geriatric Locomotive Function Scale:
This scale consists of a questionnaire of 25 items that can be easily understood by the elderly and each item is graded between 0 and 4 points. The total score is the result of the sum of all items ranging from 0 to 100; the higher the score, the higher the physical impairment of the elderly, with a score of 16 being the cut-off point for locomotive syndrome. The GLFS-25 includes 4 questions about pain, 16 questions about activities of daily living, 3 questions about social performance and 2 questions about mental health status to assess geriatric individuals. Turkish validity and reliability of the questionnaire was conducted by Sadikoglu.
| Study group | Role | What they receive |
|---|---|---|
| geriatrics individuals | Not described Receives: Other: observational physical tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Locomotive Function Scale:
This scale consists of a questionnaire of 25 items that can be easily understood by the elderly and each item is graded between 0 and 4 points. The total score is the result of the sum of all items ranging from 0 to 100; the higher the score, the higher the physical impairment of the elderly, with a score of 16 being the cut-off point for locomotive syndrome. The GLFS-25 includes 4 questions about pain, 16 questions about activities of daily living, 3 questions about social performance and 2 questions about mental health status to assess geriatric individuals. Turkish validity and reliability of the questionnaire was conducted by Sadikoglu.
Measured: 10 minute
Secondary outcomes (3)
Chair sit-lie test
The patient is asked to sit and stand as quickly as possible in a chair with a seat height of 43.2 cm and a supported back. The patient sits on the chair.He crosses his hands on his chest. 2 attempts are made before the test. A stopwatch is kept for 30 seconds and the number of sit-ups is noted. Less than 10 sit-ups in 30 seconds indicates lower extremity muscle weakness
Measured: 5 minute
Two-minute step test
It is applied to evaluate aerobic endurance. In order to perform the test correctly, the distance at which the participant will lift the knee is determined as the midpoint between the knee joint and the crista iliaca and marked on the wall. For a better understanding of the test is demonstrated practically. The participant is asked to start with the right foot and rhythmically raise their feet to the marked height for 2 minutes. The number of standardized right steps repeated for two minutes is recorded as a score.
Measured: 2 minute
Weight lifting test
It is applied to evaluate upper extremity muscle strength. Participant's feet is asked to sit towards the side of the chair while on the floor. The participant is asked to bend and extend their arms by lifting the dumbbell with the given instruction. As weight dumbbells of 3.63 kg for men (8-lb) and 2.27 kg for women (5-lb) are used. For a better understanding of the test, it was demonstrated and practiced. In the test, the maximum possible number of repetitions performed with the dominant arm for 30 s is considered as the score.
Measured: 2 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Nov 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricsStudies 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
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Kemal Gürbüz, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938153
- Sponsor's protocol ID
- Gurbuz02
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metabolic Syndrome, Frailty, Locomotive Syndrome, Balance and Physical Fitness in Elderly Individuals
- ClinicalTrials.gov ID
- NCT05938153
- Acronym / sponsor ID
- Gurbuz02
- Conditions
- Geriatrics, Fragility, Locomotor, Physical Fitness, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 10 Jul 2023 (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.
Metabolic syndrome (MetS) or syndrome X, which is increasingly prevalent in the world and in our country, is a disease that includes abdominal obesity, dyslipidemia, impaired glycemic control and hypertension components. It causes cardiovascular events such as myocardial hypertrophy, left ventricular diastolic dysfunction, atrial dilatation and atrial fibrillation. Low levels of physical activity can be caused by a wide variety of factors including environmental and genetic factors, age, race, sarcopenia, poor eating habits, postmenopausal period and smoking history. Factors such as genetic differences, diet, physical activity, age, gender and eating habits are reported to affect the prevalence of (MetS) and its components. Frailty is also emerging as a major issue for the elderly due to its debilitating effects on health outcomes. Frailty is a geriatric syndrome characterized by a gradual decrease in homeostatic tolerance and physiological reserve following exposure to stressors. Frailty predisposes older people to falls, delirium, hospitalizations and even death and is therefore considered a crucial transition between healthy ageing and disability. As a result of aging, degenerative changes in the central and peripheral vestibular system have been found. With age, the ability to regulate movement is impaired as a result of insufficient information in any of the sensory receptors or any disorder affecting the processing of these messages. This directly affects balance and postural control, leading to an increased risk of falls. In the light of the results of the studies in the literature, degenerative changes are observed in many systems in geriatric individuals and while the incidence of metabolic syndrome in these individuals is high, the number of studies evaluating their effects is not sufficient. Based on these deficiencies, it is aimed to examine metabolic syndrome, frailty, locomotive syndrome, balance and physical fitness in elderly individuals.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| geriatrics individuals | – | Other: observational physical tests |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Individuals aged 65 and over, 10 individuals
Key inclusion criteria (3 listed)
- Individuals aged 65 and over,
- Volunteering to participate in the research
- No cooperation and communication problems
Key exclusion criteria (4 listed)
- Individuals with neurological and orthopedic problems
- Uncontrolled hypertension
- Those with cardiac disorders
- Those with cooperation and communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational physical testsGeriatric Locomotive Function Scale: This scale consists of a questionnaire of 25 items that can be easily understood by the elderly and each item is graded between 0 and 4 points. The total score is the result of the sum of all items ranging from 0 to 100; the higher the score, the higher the physical impairment of the elderly, with a score of 16 being the cut-off point for locomotive syndrome. The GLFS-25 includes 4 questions about pain, 16 questions about activities of daily living, 3 questions about social performance and 2 questions about mental health status to assess geriatric individuals. Turkish validity and reliability of the questionnaire was conducted by Sadikoglu. | Other | geriatrics individuals |
Primary outcome
Geriatric Locomotive Function Scale:
Time frame: 10 minute
This scale consists of a questionnaire of 25 items that can be easily understood by the elderly and each item is graded between 0 and 4 points. The total score is the result of the sum of all items ranging from 0 to 100; the higher the score, the higher the physical impairment of the elderly, with a score of 16 being the cut-off point for locomotive syndrome. The GLFS-25 includes 4 questions about pain, 16 questions about activities of daily living, 3 questions about social performance and 2 questions about mental health status to assess geriatric individuals. Turkish validity and reliability of the questionnaire was conducted by Sadikoglu.
3 secondary outcomes
Chair sit-lie test
Time frame: 5 minute
Two-minute step test
Time frame: 2 minute
Weight lifting test
Time frame: 2 minute
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 24 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Geriatrics and Fragility, run by Kırıkkale 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 3 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 24 Dec 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?
Geriatric Locomotive Function Scale: (time frame: 10 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.