NCT05869487

Brief Summary

This is a prospective single-center study to evaluate a diagnostic method. The main objective of the 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. The study population are hospitalizing participants aged 75 years and older with an indication to search for sarcopenia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Dec 2023Apr 2027

First Submitted

Initial submission to the registry

May 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

December 11, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2027

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

3.3 years

First QC Date

May 11, 2023

Last Update Submit

December 22, 2025

Conditions

Keywords

SarcopeniaAbsorptiometryPhoton

Outcome Measures

Primary Outcomes (2)

  • Measurement of muscle mass using calf circumference

    Measurement with a tape measure (in centimetres) of the maximum circumference of the calf

    Day 2

  • Measurement of muscle mass using X-ray absorptiometry

    Measurement of appendicular mass by X-ray absorptiometry in kilograms

    Day 2

Secondary Outcomes (2)

  • Arm circumference

    Day 0

  • Circumference of the thigh

    Day 0

Study Arms (1)

X-ray

OTHER

Whole body x-ray absorptiometry for measurement of appendicular muscle mass in kilograms. Only one measurement per participant.

Radiation: Dual-energy X-ray absorptiometry

Interventions

Whole body x-ray absorptiometry

X-ray

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age greater than or equal to 75 years
  • 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

You may not qualify if:

  • Presence of one of two phenotypic criteria for undernutrition other than sarcopenia, which are body mass index less than 22 kilogram per square meter and weight loss (≥ 5 percent over 1 month or ≥ 10 percent over 6 months or ≥10 percent compared with usual weight before the disease).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU d'Orléans

Orléans, France

RECRUITING

Related Publications (13)

  • 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.

    PMID: 10210233BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Sarcopenia

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Matthieu COULONGEAT, MD

    CHR d'Orléans

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: This is a prospective single-center evaluation of a diagnostic method
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 22, 2023

Study Start

December 11, 2023

Primary Completion (Estimated)

April 11, 2027

Study Completion (Estimated)

April 11, 2027

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations