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NCT Number: NCT05869487

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

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Orléans

Orléans, France

Location status: Recruiting

Location contact

Matthieu COULONGEAT, MD

CONTACT

Matthieu COULONGEAT, MD

PRINCIPAL_INVESTIGATOR

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual-energy X-ray absorptiometry

Radiation

Whole body x-ray absorptiometry

Primary outcomes

  1. Measurement of muscle mass using calf circumference

    Time frame: Day 2

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

  2. Measurement of muscle mass using X-ray absorptiometry

    Time frame: Day 2

    Measurement of appendicular mass by X-ray absorptiometry in kilograms

Secondary outcomes

  1. Arm circumference

    Time frame: Day 0

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

  2. Circumference of the thigh

    Time frame: Day 0

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

Study contacts

Contact information is provided by the study sponsor or research team.

ELODIE POUGOUE

CONTACT

[email protected]

+33238744086

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: PAPY-SARCM

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 22, 2023
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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