- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05241886
Evaluation of Sarcopenia With SARC-F and Anthropometric Measurement
Evaluation Of Sarcopenia By Adding Anthropometric Measurements To The SARC-F Questionnaire
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The population of the research is individuals aged 65 and over who applied to Ege University Medical Faculty Hospital Internal Diseases Department, Geriatrics BD Outpatient Clinic. For statistical power analysis; When α=0.05 and the power of the study are 0.80, the minimum number of samples required for the study was determined as 190. The relevant sample size was calculated with the G-Power 3.0.8 package program.
Data collection tools:
- General information collection form: Investigator collect data about age, gender, chronic diseases, economic status, etc of participants
Measurement of Muscle Mass, Muscle Strength, and Gait Speed Body composition analysis was determined by electrical bioimpedance using the Tanita MC-780 multi-frequency segmental Body Composition Analyzer (Tanita Corporation, Tokyo). The appendicular skeletal muscle mass (ASM) was calculated with the Janssen equation for EWGSOP criteria and Sergi equation for EWGSOP 2 criteria. The appendicular muscle mass index (ASMI) was calculated based on the equation: ASM(kg) /height (m2).
Muscle strength (kg) was assessed with the Takei Grip Strength Dynamometer®. Handgrip strength (HS) measurements were made with the subjects in a sitting position, with the elbow and wrist in full extension, three times with an interval of five seconds on both hands, and the highest value among the measurement results was used for analysis. Gender-specific cut-offs were used to define low muscle strength (30 and 20 kg in males and females) for EWGSOP criteria, and (27 and 16 kg in males and females) for EWGSOP 2 criteria. Usual gait speed (m/s) was performed by the subjects walking 4 m with usual speed and ≤0.8 m/s was defined as low walking speed.
Anthropometric measurement:
In all participants, height was measured using a stadiometer to the nearest 0.1 cm, weight was measured unclothed to the nearest 0.1 kg using a calibrated balance scale. Body mass index (BMI) was calculated by the weight (kg)/height (m2) equation.
The calf circumference (CC) of participants was measured with an inflexible tape measure, in the sitting position, with the knee flexed to 90º, and the circumference of the widest part of the calf. Both the standard CC cut-off (<31 cm) and population-specific cut-off (<33 cm) were used and compared in SARC-CalF analysis. Mid upper arm circumference (MUAC) was measured in a stand position, the mid-point of the participant's left upper arm- located between the acromion and olecranon- was marked when the elbow bent to a 90o angle and measured with the inflexible tape around the marked midpoint with the participant's arm hung down naturally.
- Screening of sarcopenia risk and assessment of sarcopenia SARC-F, SARC-CalF, and SARC-MUAC were used for screening sarcopenia risk. For the SARC-F total score of ≥4, SARC-CalF ≥11, and SARC-MUAC≥11 were defined as positive sarcopenia risk. Investigator used EWGSOP and EWGSOP 2 criteria for sarcopenia diagnosis.
- Statistic analysis: SPSS 25.0 (SPSS Statistics; IBM, Armonk, NY) and MedCalc Statistical Software 19.1.6-free trial (MedCalc Software, Ostend, Belgium) statistical package programs were used for statistical analysis. The level of significance was defined as p<0.05.
For categorical variables, the data were presented as numbers (percentage). Continuous variables with normal or skewed distribution were presented as mean (standard deviation) or median (interquartile range), respectively. Group differences were investigated using the t-test for normally distributed data and the Mann-Whitney test for skewed data and the X2 or Fisher's exact test for categorical data was used. Using EWGSOP and EWGSOP 2 criteria as the reference standard, the investigator calculated the diagnostic value of the SARC-F, SARC-CalF- 31, and SARC-CalF-33 [sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy] for identifying sarcopenia. A receiver operating characteristics (ROC) curve was used to compare the overall accuracy of SARC-F, SARC-CalF-31, and SARC-CalF-33. The area under the ROC curve (AUC) and 95% confidence interval (CI) were calculated.
The exclusion criteria are as follows: an implanted pacemaker, severe mental illness, unable to walk, severe heart failure, severe renal failure, clinically visible edema, and unable to communicate.
Participants in which all the evaluations in the research protocol were carried out and answered all the questions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bornova
-
Izmir, Bornova, Turkey, 35100
- Ege University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
participants who applied to the geriatrics outpatient clinic for any reason
Exclusion Criteria:
Participants with an implanted pacemaker, severe mental illness, unable to walk, severe heart failure, severe renal failure, clinically visible edema, and unable to communicate.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sarcopenia prevalance
Time Frame: Day 1
|
number
|
Day 1
|
SARC-F score
Time Frame: Day 1
|
number
|
Day 1
|
mid-upper arm circumference
Time Frame: Day 1
|
cm
|
Day 1
|
calf circumference
Time Frame: Day 1
|
cm
|
Day 1
|
Appendicular skeletal muscle mass index
Time Frame: Day 1
|
kg/m2
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: yasemin A Atik-Altinok, PhD, Ege University
- Study Director: Devrim Bozkurt, Assoc Prof, Ege University
- Principal Investigator: Sumru Savaş, Assoc Prof, Ege University
- Principal Investigator: Reci Meseri, Assoc Prof, Ege University
- Principal Investigator: Fulden Saraç, Prof Dr, Ege University
- Principal Investigator: Fehmi Akçiçek, Prof Dr, Ege University
Publications and helpful links
General Publications
- Ates Bulut E, Soysal P, Dokuzlar O, Kocyigit SE, Aydin AE, Yavuz I, Isik AT. Validation of population-based cutoffs for low muscle mass and strength in a population of Turkish elderly adults. Aging Clin Exp Res. 2020 Sep;32(9):1749-1755. doi: 10.1007/s40520-019-01448-4. Epub 2020 Jan 2.
- Abd-El-Gawad WM, Abou-Hashem RM, El Maraghy MO, Amin GE. The validity of Geriatric Nutrition Risk Index: simple tool for prediction of nutritional-related complication of hospitalized elderly patients. Comparison with Mini Nutritional Assessment. Clin Nutr. 2014 Dec;33(6):1108-16. doi: 10.1016/j.clnu.2013.12.005. Epub 2013 Dec 28.
- Bahat G, Yilmaz O, Kilic C, Oren MM, Karan MA. Performance of SARC-F in Regard to Sarcopenia Definitions, Muscle Mass and Functional Measures. J Nutr Health Aging. 2018;22(8):898-903. doi: 10.1007/s12603-018-1067-8.
- Fu X, Tian Z, Thapa S, Sun H, Wen S, Xiong H, Yu S. Comparing SARC-F with SARC-CalF for screening sarcopenia in advanced cancer patients. Clin Nutr. 2020 Nov;39(11):3337-3345. doi: 10.1016/j.clnu.2020.02.020. Epub 2020 Feb 22.
- Sergi G, De Rui M, Veronese N, Bolzetta F, Berton L, Carraro S, Bano G, Coin A, Manzato E, Perissinotto E. Assessing appendicular skeletal muscle mass with bioelectrical impedance analysis in free-living Caucasian older adults. Clin Nutr. 2015 Aug;34(4):667-73. doi: 10.1016/j.clnu.2014.07.010. Epub 2014 Jul 24.
- da Luz MCL, Pinho CPS, Bezerra GKA, da Conceicao Chaves de Lemos M, da Silva Diniz A, Cabral PC. SARC-F and SARC-CalF in screening for sarcopenia in older adults with Parkinson's disease. Exp Gerontol. 2021 Feb;144:111183. doi: 10.1016/j.exger.2020.111183. Epub 2020 Dec 3.
- Hajaoui M, Locquet M, Beaudart C, Reginster JY, Petermans J, Bruyere O. Sarcopenia: Performance of the SARC-F Questionnaire According to the European Consensus Criteria, EWGSOP1 and EWGSOP2. J Am Med Dir Assoc. 2019 Sep;20(9):1182-1183. doi: 10.1016/j.jamda.2019.05.021. No abstract available.
- Drey M, Ferrari U, Schraml M, Kemmler W, Schoene D, Franke A, Freiberger E, Kob R, Sieber C. German Version of SARC-F: Translation, Adaption, and Validation. J Am Med Dir Assoc. 2020 Jun;21(6):747-751.e1. doi: 10.1016/j.jamda.2019.12.011. Epub 2020 Jan 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sarcopenia001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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