Geriatric IndividualsNCT06394648
Investigation of Sarcopenia and Physical Fitness Levels of Geriatric Individuals Living in Nursing Homes and at Home
An observational study of Geriatric Individuals, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
To examine the sarcopenia and physical fitness levels of geriatric individuals living in nursing homes and at home. Considering these aims, our working hypotheses are; H1: There is a difference in sarcopenia level between geriatric individuals living in a nursing home and at home. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Geriatric Individuals
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2024to 15 Jul 2024
- 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 85 years
- All sexes
- Older adult
Study population: Geriatric individuals
Who may be able to join
- Getting a score between 24 and 30 on the Mini Mental State Exam
- Living in a nursing home for at least six months (for nursing home residents)
- Ability to stand without assistance for at least 90 seconds
Who cannot join
- Inability to communicate verbally
- Using a walking aid
- Elderly people with severe visual impairment, neurological disorders and/or congestive heart failure
- Older adults for whom exercise is not recommended
Trial locations and contacts
1 site in 1 country.
About this study
To examine the sarcopenia and physical fitness levels of geriatric individuals living in nursing homes and at home. Considering these aims, our working hypotheses are;
H1: There is a difference in sarcopenia level between geriatric individuals living in a nursing home and at home.
H2: There is a difference in dynapenia levels between geriatric individuals living in a nursing home and at home.
H3: There is a difference in physical fitness between geriatric individuals living in a nursing home and at home.
Read the detailed description
Geriatric individuals living in the Nursing Home and at home will be included in the research. Within the scope of the study, anterior thigh thickness of geriatric individuals will be evaluated by ultrasonography and the presence of sarcopenia will be determined according to the Sonographic T-high Adjustment Rate (STAR) method, and the presence of dynapenia will be determined according to hand grip strength in individuals without sarcopenia. Additionally, the physical fitness of geriatric individuals in both groups will be evaluated with the Senior Fitness test. The study will be carried out with 100 geriatric individuals. As a result of the study, individuals in the groups will be compared in terms of the presence of sarcopenia and dynapenia and physical fitness.
- Conditions
- Geriatric Individuals
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 |
|---|---|---|
| Geriatric individuals living in nursing homes | Geriatric individuals living in nursing homes will be included. | |
| Geriatric individuals living at home | Geriatric individuals living at home will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography Evaluation:
Anterior thigh muscle thickness will be measured to evaluate sarcopenia. The obtained value will be divided by Body Mass Index (BMI). This evaluation method is referred to in the literature as the Sonographic T-high Adjustment Rate (STAR) method. Ultrasonographic measurements will be made by a physician with at least 10 years of experience in this field using linear probes.
Measured: Baseline
Senior Fitness Test
This test evaluates the level of functional fitness at which activities of daily living can be performed safely and independently without fatigue. In daily life, physiological parameters are related to performance. Senior Fitness Test evaluates physiological parameters such as muscle strength, flexibility, aerobic endurance, balance and body composition. Senior Fitness Test consists of seven subtests and determination of body composition: Chair sit-to-stand test, weight lifting test, six-minute walk or two-minute step test, chair sit-and-reach test, back scratching test, eight-step up-to-walk test and determination of body mass index.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start28 Apr 2024
- Primary completion20 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Geriatric IndividualsStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Korkusuz, Hacettepe University
- Investigators
- Süleyman Korkusuz, PhD, Principal investigator, Atılım UniversityÖzlem Yürük, Prof.Dr, Study chair, Baskent UniversityBüşra Seçkinoğulları Korkusuz, MSc, Study chair, Hacettepe UniversityFerdi Yavuz, Assoc.Prof., Study chair, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394648
- Sponsor's protocol ID
- E-59394181-604.01-83960
- Status last verified
- Aug 2024
- First submitted
- 28 Apr 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.
PubMed 32941253Wang JC, Wu WT, Chang KV, Chen LR, Chi SY, Kara M, Ozcakar L. Ultrasound Imaging for the Diagnosis and Evaluation of Sarcopenia: An Umbrella Review. Life (Basel). 2021 Dec 22;12(1):9. doi: 10.3390/life12010009.
PubMed 35054402Kazoglu M, Yuruk ZO. Comparison of the physical fitness levels in nursing home residents and community-dwelling older adults. Arch Gerontol Geriatr. 2020 Jul-Aug;89:104106. doi: 10.1016/j.archger.2020.104106. Epub 2020 May 15.
PubMed 32447125Korkusuz BS, Korkusuz S, Yavuz F, Yuruk ZO. Sarcopenia severity and physical fitness levels in nursing home residents and community-dwelling older adults. Ir J Med Sci. 2026 May 29. doi: 10.1007/s11845-026-04467-z. Online ahead of print.
PubMed 42213398
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Sarcopenia and Physical Fitness Levels of Geriatric Individuals Living in Nursing Homes and at Home
- ClinicalTrials.gov ID
- NCT06394648
- Acronym / sponsor ID
- E-59394181-604.01-83960
- Conditions
- Geriatric Individuals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Apr 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 1 May 2024 (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.
To examine the sarcopenia and physical fitness levels of geriatric individuals living in nursing homes and at home. Considering these aims, our working hypotheses are;
H1: There is a difference in sarcopenia level between geriatric individuals living in a nursing home and at home.
H2: There is a difference in dynapenia levels between geriatric individuals living in a nursing home and at home.
H3: There is a difference in physical fitness between geriatric individuals living in a nursing home and at home.
Detailed description
Geriatric individuals living in the Nursing Home and at home will be included in the research. Within the scope of the study, anterior thigh thickness of geriatric individuals will be evaluated by ultrasonography and the presence of sarcopenia will be determined according to the Sonographic T-high Adjustment Rate (STAR) method, and the presence of dynapenia will be determined according to hand grip strength in individuals without sarcopenia. Additionally, the physical fitness of geriatric individuals in both groups will be evaluated with the Senior Fitness test. The study will be carried out with 100 geriatric individuals. As a result of the study, individuals in the groups will be compared in terms of the presence of sarcopenia and dynapenia and physical fitness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geriatric individuals living in nursing homes | – | –Geriatric individuals living in nursing homes will be included. |
| Geriatric individuals living at home | – | –Geriatric individuals living at home will be included. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Geriatric individuals
Key inclusion criteria (3 listed)
- Getting a score between 24 and 30 on the Mini Mental State Exam
- Living in a nursing home for at least six months (for nursing home residents)
- Ability to stand without assistance for at least 90 seconds
Key exclusion criteria (4 listed)
- Inability to communicate verbally
- Using a walking aid
- Elderly people with severe visual impairment, neurological disorders and/or congestive heart failure
- Older adults for whom exercise is not recommended
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
Ultrasonography Evaluation:
Time frame: Baseline
Anterior thigh muscle thickness will be measured to evaluate sarcopenia. The obtained value will be divided by Body Mass Index (BMI). This evaluation method is referred to in the literature as the Sonographic T-high Adjustment Rate (STAR) method. Ultrasonographic measurements will be made by a physician with at least 10 years of experience in this field using linear probes.
Senior Fitness Test
Time frame: Baseline
This test evaluates the level of functional fitness at which activities of daily living can be performed safely and independently without fatigue. In daily life, physiological parameters are related to performance. Senior Fitness Test evaluates physiological parameters such as muscle strength, flexibility, aerobic endurance, balance and body composition. Senior Fitness Test consists of seven subtests and determination of body composition: Chair sit-to-stand test, weight lifting test, six-minute walk or two-minute step test, chair sit-and-reach test, back scratching test, eight-step up-to-walk test and determination of body mass index.
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 19 Aug 2024.
- Background: PubMed 32941253Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.
- Background: PubMed 35054402Wang JC, Wu WT, Chang KV, Chen LR, Chi SY, Kara M, Ozcakar L. Ultrasound Imaging for the Diagnosis and Evaluation of Sarcopenia: An Umbrella Review. Life (Basel). 2021 Dec 22;12(1):9. doi: 10.3390/life12010009.
- Background: PubMed 32447125Kazoglu M, Yuruk ZO. Comparison of the physical fitness levels in nursing home residents and community-dwelling older adults. Arch Gerontol Geriatr. 2020 Jul-Aug;89:104106. doi: 10.1016/j.archger.2020.104106. Epub 2020 May 15.
- Derived from this study: PubMed 42213398Korkusuz BS, Korkusuz S, Yavuz F, Yuruk ZO. Sarcopenia severity and physical fitness levels in nursing home residents and community-dwelling older adults. Ir J Med Sci. 2026 May 29. doi: 10.1007/s11845-026-04467-z. Online ahead of print.
- 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.
Süleyman Korkusuz, PhD principal investigator
Atılım University
Özlem Yürük, Prof.Dr study chair
Baskent University
Büşra Seçkinoğulları Korkusuz, MSc study chair
Hacettepe 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 Geriatric Individuals, run by Hacettepe 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 19 Aug 2024. 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?
Ultrasonography Evaluation: (time frame: Baseline). The study lists 2 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 NCT06394648, which also lists 4 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 19 Aug 2024.