CHU d'Orléans
Orléans, France
Location status: Recruiting
Location contact
Matthieu COULONGEAT, MD
CONTACT
Matthieu COULONGEAT, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05869487
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.
Interested in participating?
Request Info75 year and older
All sexes
Interventional
Not applicable
Orléans, France
Location status: Recruiting
Matthieu COULONGEAT, MD
CONTACT
Matthieu COULONGEAT, MD
PRINCIPAL_INVESTIGATOR
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%.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Whole body x-ray absorptiometry
Time frame: Day 2
Measurement with a tape measure (in centimetres) of the maximum circumference of the calf
Time frame: Day 2
Measurement of appendicular mass by X-ray absorptiometry in kilograms
Time frame: Day 0
Measurement with a tape measure (in centimetres) of the maximum circumference of the arm
Time frame: Day 0
Measurement with a tape measure (in centimetres) of the maximum circumference of the thigh
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Régional d'Orléans
Other
Evaluation of a Diagnostic Method: Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Participants
Acronym: PAPY-SARCM
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