SarcopeniaNCT04146844
Prevalence of Two Major Geriatric Syndromes: Sarcopenia and Frailty
An observational study of Sarcopenia and Frailty, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Sarcopenia and frailty are two major syndromes in older adults. They are shown to be associated with low levels of functioning and higher rates of morbidity and mortality. In this study, we aim to report the prevalence of sarcopenia and frailty by using simple assessment methods such as SARC-F and FRAIL, respectively. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Frailty, Frailty Syndrome
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 25 Apr 2021
- 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
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling older adults
Who may be able to join
- Being at the age of 65 or older
Who cannot join
- <24 points on Mini-Mental State Examination
- 12 points or higher on Geriatric Depression Scale
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Education and Research Hospital
Istanbul, 34722
About this study
Official title: Prevalence of Two Major Geriatric Syndromes in Community- Dwelling Older Adults: Sarcopenia and Frailty
Sarcopenia and frailty are two major syndromes in older adults. They are shown to be associated with low levels of functioning and higher rates of morbidity and mortality. In this study, we aim to report the prevalence of sarcopenia and frailty by using simple assessment methods such as SARC-F and FRAIL, respectively.
- Conditions
- Sarcopenia, Frailty, Frailty Syndrome
- Medical subject headings
- Sarcopenia, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
SARC-F
SARC-F is a rapid tool to assess sarcopenia in elderly. It is considered indicative sign of sarcopenia if the person scores 4 points or higher out of 10 points.
Measured: 5 minutes
FRAIL
The FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight) is a simple questionnaire of frailty syndrome for older adults. If a patient scores 3-5 points over a total score of 5 points in the FRAIL, he is considered as frail.
Measured: 5 minutes
Secondary outcomes (9)
Study of Osteoporotic Fracture (SOF) Criteria for Frailty
SOF is another index for measuring frailty. 2 or 3 points out of 3 points are considered as cut-off points for frailty.
Measured: 5 minutes
Charlson Comorbidity Index
For comorbidity assessment
Measured: 5-10 minutes
Rapid Assessment of Physical Activity (RAPA)
For the assessment of physical activity level
Measured: 10 minutes
Mini-Nutritional Assessment (MNA)
Assessment of nutritional status
Measured: 10 minutes
Katz Index of Independence in Activities of Daily Living
Assessment of activities of daily living
Measured: 10 minutes
Lawton -Brody Instrumental Activities of Daily Living Scale
Instrumental activities of daily living assessment
Measured: 10 minutes
Mini-Mental State Examination
Mini-Mental State Examination
Measured: 15 minutes
Blood Sample Analysis
A blood sample analysis will be performed to investigate the relationship between blood parameters, sarcopenia and frailty.
Measured: 5 minutes
Geriatric Depression Scale- Short Form
Assessment of depression
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start15 Dec 2020
- Primary completion1 Apr 2021
- Study completion25 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medeniyet University, Umraniye Education and Research Hospital
- Responsible party
- Principal investigator, Filiz Demirdağ, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146844
- Sponsor's protocol ID
- GoztepeTRH1
- Status last verified
- May 2021
- First submitted
- 28 Oct 2019
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- 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 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Two Major Geriatric Syndromes in Community- Dwelling Older Adults: Sarcopenia and Frailty
- ClinicalTrials.gov ID
- NCT04146844
- Acronym / sponsor ID
- GoztepeTRH1
- Conditions
- Sarcopenia, Frailty, Frailty Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Goztepe Training and Research HospitalUniversity, hospital or other
- Collaborators
- Istanbul Medeniyet University, Umraniye Education and Research Hospital
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 25 Apr 2021 (actual)
- First posted
- 31 Oct 2019 (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.
Sarcopenia and frailty are two major syndromes in older adults. They are shown to be associated with low levels of functioning and higher rates of morbidity and mortality. In this study, we aim to report the prevalence of sarcopenia and frailty by using simple assessment methods such as SARC-F and FRAIL, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older adults
Key inclusion criteria (1 listed)
- Being at the age of 65 or older
Key exclusion criteria (2 listed)
- <24 points on Mini-Mental State Examination
- 12 points or higher on Geriatric Depression Scale
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
SARC-F
Time frame: 5 minutes
SARC-F is a rapid tool to assess sarcopenia in elderly. It is considered indicative sign of sarcopenia if the person scores 4 points or higher out of 10 points.
FRAIL
Time frame: 5 minutes
The FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight) is a simple questionnaire of frailty syndrome for older adults. If a patient scores 3-5 points over a total score of 5 points in the FRAIL, he is considered as frail.
9 secondary outcomes
Study of Osteoporotic Fracture (SOF) Criteria for Frailty
Time frame: 5 minutes
Charlson Comorbidity Index
Time frame: 5-10 minutes
Rapid Assessment of Physical Activity (RAPA)
Time frame: 10 minutes
Mini-Nutritional Assessment (MNA)
Time frame: 10 minutes
Katz Index of Independence in Activities of Daily Living
Time frame: 10 minutes
Lawton -Brody Instrumental Activities of Daily Living Scale
Time frame: 10 minutes
Mini-Mental State Examination
Time frame: 15 minutes
Blood Sample Analysis
Time frame: 5 minutes
Geriatric Depression Scale- Short Form
Time frame: 10 minutes
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 10 May 2021.
- 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 Sarcopenia and Frailty, run by Goztepe Training and Research Hospital 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 1 inclusion and 2 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 10 May 2021. 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?
SARC-F (time frame: 5 minutes). 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?
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 10 May 2021.