SarcopeniaNCT05567549
Evaluation of Sarcopenia in Elderly at the Emergency Department
An observational study of Sarcopenia, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate in elderly patients for the frequency of sarcopenia and its relationship with mortality in a university hospital. The main questions it aims to answer are; 1. What is the frequency of sarcopenia in elderly patients at emergency department? 2. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2022to 10 Sep 2023
- 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: Patients over 65 years of age, who can walk independently, who do not have lower extremity fractures or neuromuscular disease, will constitute the study population. The mortality rate over the age of 65 was found to be 11%. Considering that the mortality rate with sarcopenia was 28%, it was found that 63 patients were required for the effect of sarcopenia on mortality with a 95% confidence interval and 0.5% margin of error. Since the incidence of sarcopenia in the emergency department was 33%, 200 patients were planned to be included in the study.
Who may be able to join
- Above the age of 65 admitted to the emergency department
- Able to walk without support
- No lower extremity fracture
- No disease with neuromuscular involvement
Who cannot join
- In the presence of a cerebrovascular event
- Those in need of critical intervention when applying to the emergency department
- Unconscious patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University
Izmir
Özge Can, +905054499887, ozge.can@ege.edu.tr
About this study
Official title: Frequency of Sarcopenia and Relation With Mortality in Elderly at the Emergency Department
The goal of this observational study is to evaluate in elderly patients for the frequency of sarcopenia and its relationship with mortality in a university hospital.
The main questions it aims to answer are;
- What is the frequency of sarcopenia in elderly patients at emergency department?
- Is sarcopenia associated with mortality in an elderly patient admitted to the emergency department?
- Conditions
- Sarcopenia
- Medical subject headings
- Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 0-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start10 Oct 2022 (estimated)
- Primary completion10 Jul 2023 (estimated)
- Study completion10 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Ege 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
- Case only
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Can. MD, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567549
- Sponsor's protocol ID
- 22-8.1T/60
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Morley JE. Sarcopenia: diagnosis and treatment. J Nutr Health Aging. 2008 Aug-Sep;12(7):452-6. doi: 10.1007/BF02982705. No abstract available.
PubMed 18615226Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Roberts S, Collins P, Rattray M. Identifying and Managing Malnutrition, Frailty and Sarcopenia in the Community: A Narrative Review. Nutrients. 2021 Jul 5;13(7):2316. doi: 10.3390/nu13072316.
PubMed 34371823Hung SK, Kou HW, Hsu KH, Wu CT, Lee CW, Leonard Goh ZN, Seak CK, Chen-Yeen Seak J, Liu YT, Seak CJ; SPOT investigators. Sarcopenia is a useful risk stratification tool to prognosticate splenic abscess patients in the emergency department. J Formos Med Assoc. 2021 Mar;120(3):997-1004. doi: 10.1016/j.jfma.2020.08.039. Epub 2020 Sep 9.
PubMed 32917483McQuade C, Kavanagh DO, O'Brien C, Hunter K, Nally D, Hickie C, Ward E, Torreggiani WC. CT-determined sarcopenia as a predictor of post-operative outcomes in patients undergoing an emergency laparotomy. Clin Imaging. 2021 Nov;79:273-277. doi: 10.1016/j.clinimag.2021.05.015. Epub 2021 May 18.
PubMed 34171595
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Sarcopenia and Relation With Mortality in Elderly at the Emergency Department
- ClinicalTrials.gov ID
- NCT05567549
- Acronym / sponsor ID
- 22-8.1T/60
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 10 Jul 2023 (estimated)
- Study completion
- 10 Sep 2023 (estimated)
- First posted
- 5 Oct 2022 (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.
The goal of this observational study is to evaluate in elderly patients for the frequency of sarcopenia and its relationship with mortality in a university hospital.
The main questions it aims to answer are;
- What is the frequency of sarcopenia in elderly patients at emergency department?
- Is sarcopenia associated with mortality in an elderly patient admitted to the emergency department?
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients over 65 years of age, who can walk independently, who do not have lower extremity fractures or neuromuscular disease, will constitute the study population. The mortality rate over the age of 65 was found to be 11%. Considering that the mortality rate with sarcopenia was 28%, it was found that 63 patients were required for the effect of sarcopenia on mortality with a 95% confidence interval and 0.5% margin of error. Since the incidence of sarcopenia in the emergency department was 33%, 200 patients were planned to be included in the study.
Key inclusion criteria (4 listed)
- Above the age of 65 admitted to the emergency department
- Able to walk without support
- No lower extremity fracture
- No disease with neuromuscular involvement
Key exclusion criteria (3 listed)
- In the presence of a cerebrovascular event
- Those in need of critical intervention when applying to the emergency department
- Unconscious patients
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
Mortality
Time frame: 0-28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Background: PubMed 18615226Morley JE. Sarcopenia: diagnosis and treatment. J Nutr Health Aging. 2008 Aug-Sep;12(7):452-6. doi: 10.1007/BF02982705. No abstract available.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Background: PubMed 34371823Roberts S, Collins P, Rattray M. Identifying and Managing Malnutrition, Frailty and Sarcopenia in the Community: A Narrative Review. Nutrients. 2021 Jul 5;13(7):2316. doi: 10.3390/nu13072316.
- Background: PubMed 32917483Hung SK, Kou HW, Hsu KH, Wu CT, Lee CW, Leonard Goh ZN, Seak CK, Chen-Yeen Seak J, Liu YT, Seak CJ; SPOT investigators. Sarcopenia is a useful risk stratification tool to prognosticate splenic abscess patients in the emergency department. J Formos Med Assoc. 2021 Mar;120(3):997-1004. doi: 10.1016/j.jfma.2020.08.039. Epub 2020 Sep 9.
- Background: PubMed 34171595McQuade C, Kavanagh DO, O'Brien C, Hunter K, Nally D, Hickie C, Ward E, Torreggiani WC. CT-determined sarcopenia as a predictor of post-operative outcomes in patients undergoing an emergency laparotomy. Clin Imaging. 2021 Nov;79:273-277. doi: 10.1016/j.clinimag.2021.05.015. Epub 2021 May 18.
- Individual participant dataSharing planned: Undecided
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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.
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 Ege 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 3 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: status not confirmed, as of the sponsor's last update on 5 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 0-28 days). 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 NCT05567549, which also lists 5 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 5 Oct 2022.