Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Patients
NCT ID: NCT05869487
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
298 participants
INTERVENTIONAL
2023-12-11
2027-04-11
Brief Summary
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Detailed Description
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The main objective of this study is to evaluate the performance of calf circumference as a diagnostic method for sarcopenia in hospitalized elderly people, compared to a gold standard method which is X-ray absorptiometry.
This is a single-center prospective study to evaluate a diagnostic method. The participants in the study will be hospitalized patients aged 75 years and over, with an indication to search for sarcopenia in the context of screening for protein-energy undernutrition under the recommendations of the French National Authority for Health. Participants will be included after being informed about the protocol and after obtaining their free and informed oral consent. Measurement of calf circumference will be performed before absorptiometry, the results of which will be analyzed in a blinded. The number of subjects to be included with a expected prevalence of 75%, specificity of 95% and an accuracy of 2% is 298 participants according to the literature. A sensitivity and specificity analysis will be performed using the ROC curve. A linear regression analysis will be performed with a significance threshold for the alpha risk of 5%.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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X-ray
Whole body x-ray absorptiometry for measurement of appendicular muscle mass in kilograms. Only one measurement per participant.
Dual-energy X-ray absorptiometry
Whole body x-ray absorptiometry
Interventions
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Dual-energy X-ray absorptiometry
Whole body x-ray absorptiometry
Eligibility Criteria
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Inclusion Criteria
* Hospitalization in a medical department or in the follow-up care or rehabilitation department of the Hospital Center of Orléans
* Presence of an etiological criterion of undernutrition
* Presence of a decrease in muscle strength
Exclusion Criteria
* Refusal to participate in the study
* Patient under legal protection
* Impossible to perform X-ray absorptiometry (behavioral problems, functional constraints to climb on the DXA machine)
* Person not affiliated to a social security system
75 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Principal Investigators
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Matthieu COULONGEAT, MD
Role: PRINCIPAL_INVESTIGATOR
CHR d'Orléans
Locations
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CHU d'Orléans
Orléans, , France
Countries
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Central Contacts
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Facility Contacts
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Matthieu COULONGEAT, MD
Role: primary
References
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Pagotto V, Santos KFD, Malaquias SG, Bachion MM, Silveira EA. Calf circumference: clinical validation for evaluation of muscle mass in the elderly. Rev Bras Enferm. 2018 Mar-Apr;71(2):322-328. doi: 10.1590/0034-7167-2017-0121. English, Portuguese.
Librero J, Peiro S, Ordinana R. Chronic comorbidity and outcomes of hospital care: length of stay, mortality, and readmission at 30 and 365 days. J Clin Epidemiol. 1999 Mar;52(3):171-9. doi: 10.1016/s0895-4356(98)00160-7.
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
Rolland Y, Lauwers-Cances V, Cournot M, Nourhashemi F, Reynish W, Riviere D, Vellas B, Grandjean H. Sarcopenia, calf circumference, and physical function of elderly women: a cross-sectional study. J Am Geriatr Soc. 2003 Aug;51(8):1120-4. doi: 10.1046/j.1532-5415.2003.51362.x.
Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017.
Kawakami R, Murakami H, Sanada K, Tanaka N, Sawada SS, Tabata I, Higuchi M, Miyachi M. Calf circumference as a surrogate marker of muscle mass for diagnosing sarcopenia in Japanese men and women. Geriatr Gerontol Int. 2015 Aug;15(8):969-76. doi: 10.1111/ggi.12377. Epub 2014 Sep 20.
Bahat G, Tufan A, Tufan F, Kilic C, Akpinar TS, Kose M, Erten N, Karan MA, Cruz-Jentoft AJ. Cut-off points to identify sarcopenia according to European Working Group on Sarcopenia in Older People (EWGSOP) definition. Clin Nutr. 2016 Dec;35(6):1557-1563. doi: 10.1016/j.clnu.2016.02.002. Epub 2016 Feb 11.
Maeda K, Koga T, Nasu T, Takaki M, Akagi J. Predictive Accuracy of Calf Circumference Measurements to Detect Decreased Skeletal Muscle Mass and European Society for Clinical Nutrition and Metabolism-Defined Malnutrition in Hospitalized Older Patients. Ann Nutr Metab. 2017;71(1-2):10-15. doi: 10.1159/000478707. Epub 2017 Jun 24.
Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
Dodds RM, Syddall HE, Cooper R, Benzeval M, Deary IJ, Dennison EM, Der G, Gale CR, Inskip HM, Jagger C, Kirkwood TB, Lawlor DA, Robinson SM, Starr JM, Steptoe A, Tilling K, Kuh D, Cooper C, Sayer AA. Grip strength across the life course: normative data from twelve British studies. PLoS One. 2014 Dec 4;9(12):e113637. doi: 10.1371/journal.pone.0113637. eCollection 2014.
Studenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT. The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):547-58. doi: 10.1093/gerona/glu010.
Gould H, Brennan SL, Kotowicz MA, Nicholson GC, Pasco JA. Total and appendicular lean mass reference ranges for Australian men and women: the Geelong osteoporosis study. Calcif Tissue Int. 2014 Apr;94(4):363-72. doi: 10.1007/s00223-013-9830-7. Epub 2014 Jan 5.
Cheng KY, Chow SK, Hung VW, Wong CH, Wong RM, Tsang CS, Kwok T, Cheung WH. Diagnosis of sarcopenia by evaluating skeletal muscle mass by adjusted bioimpedance analysis validated with dual-energy X-ray absorptiometry. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):2163-2173. doi: 10.1002/jcsm.12825. Epub 2021 Oct 4.
Other Identifiers
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CHRO-2023-02
Identifier Type: -
Identifier Source: org_study_id