PAPY-SARCM: Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Patients
Study Details
Study Description
Brief Summary
This is a prospective single-center study to evaluate a diagnostic method. The main objective of the study is to evaluate the sensitivity, specificity and correlation between calf circumference and X-ray absorptiometry (gold standard) in the assessment of muscle mass for the diagnosis of sarcopenia. The study population is hospitalized participants aged 75 years and older with an indication to search for sarcopenia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 diagnostic performance of calf circumference in measuring muscle mass in hospitalized elderly patients compared to the gold standard of 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 to demonstrate a sensibility of 70% with an accuracy of 4% is 101 subjects and an estimated prevalence of 40% 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%.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: X-ray Whole body x-ray absorptiometry for measurement of appendicular muscle mass in kilograms. Only one measurement per participant. |
Radiation: Dual-energy X-ray absorptiometry
Whole body x-ray absorptiometry
|
Outcome Measures
Primary Outcome Measures
- Measurement of muscle mass using calf circumference [Day 2]
Measurement with a tape measure (in centimetres) of the maximum circumference of the calf
- Measurement of muscle mass using X-ray absorptiometry [Day 2]
Measurement of appendicular mass by X-ray absorptiometry in kilograms
Secondary Outcome Measures
- Arm circumference [Day 0]
Measurement with a tape measure (in centimetres) of the maximum circumference of the arm
- Circumference of the thigh [Day 0]
Measurement with a tape measure (in centimetres) of the maximum circumference of the thigh
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age greater than or equal to 75 years
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Hospitalization in a medical department or in the follow-up care or rehabilitation department of the Hospital Center of Orléans
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Presence of an etiological criterion of undernutrition
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Presence of a decrease in muscle strength
Exclusion Criteria:
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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).
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Refusal to participate in the study
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Patient under legal protection
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Impossible to perform X-ray absorptiometry (behavioral problems, functional constraints to climb on the DXA machine)
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Person not affiliated to a social security system
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHR d'Orléans | Orléans | France |
Sponsors and Collaborators
- Centre Hospitalier Régional d'Orléans
Investigators
- Principal Investigator: Matthieu COULONGEAT, MD, CHR d'Orléans
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Erratum In: Age Ageing. 2019 Jul 1;48(4):601.
- 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.
- CHRO-2023-02