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Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Patients

Evaluation of a Diagnostic Method: Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Participants

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05869487
Acronym
PAPY-SARCM
Enrollment
298
Registered
2023-05-22
Start date
2023-12-11
Completion date
2027-04-11
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

Sarcopenia, Absorptiometry, Photon

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.

Detailed description

Sarcopenia is a loss of muscle mass associated with a loss of muscle strength. Sarcopenia is associated with an increase of mortality, risk of falling and hospitalization. The gold standard for assessing loss of muscle mass is X-ray absorptiometry. However, this exam is not systematically performed. The calf circumference (cutoff less than 31 centimeters) is preferentially used. However, this cutoff was defined from a population of women with a mean age of 80 years and a unfrail phenotypic profile that does not allow this result to be applied to elderly hospitalized patients. 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%.

Interventions

Whole body x-ray absorptiometry

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

This is a prospective single-center evaluation of a diagnostic method

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of muscle mass using calf circumferenceDay 2Measurement with a tape measure (in centimetres) of the maximum circumference of the calf
Measurement of muscle mass using X-ray absorptiometryDay 2Measurement of appendicular mass by X-ray absorptiometry in kilograms

Secondary

MeasureTime frameDescription
Arm circumferenceDay 0Measurement with a tape measure (in centimetres) of the maximum circumference of the arm
Circumference of the thighDay 0Measurement with a tape measure (in centimetres) of the maximum circumference of the thigh

Countries

France

Contacts

Primary ContactELODIE POUGOUE
elodie.pougoue-touko@chr-orleans.fr+33238744086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026