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Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Patients (PAPY-SARCM)

Primary Purpose

Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dual-energy X-ray absorptiometry
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcopenia focused on measuring Sarcopenia, Absorptiometry, Photon

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'Orléans

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

X-ray

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 11, 2023
Last Updated
September 22, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT05869487
Brief Title
Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Patients
Acronym
PAPY-SARCM
Official Title
Evaluation of a Diagnostic Method: Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Participants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Absorptiometry, Photon

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective single-center evaluation of a diagnostic method
Masking
None (Open Label)
Allocation
N/A
Enrollment
298 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
X-ray
Arm Type
Other
Arm Description
Whole body x-ray absorptiometry for measurement of appendicular muscle mass in kilograms. Only one measurement per participant.
Intervention Type
Radiation
Intervention Name(s)
Dual-energy X-ray absorptiometry
Intervention Description
Whole body x-ray absorptiometry
Primary Outcome Measure Information:
Title
Measurement of muscle mass using calf circumference
Description
Measurement with a tape measure (in centimetres) of the maximum circumference of the calf
Time Frame
Day 2
Title
Measurement of muscle mass using X-ray absorptiometry
Description
Measurement of appendicular mass by X-ray absorptiometry in kilograms
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Arm circumference
Description
Measurement with a tape measure (in centimetres) of the maximum circumference of the arm
Time Frame
Day 0
Title
Circumference of the thigh
Description
Measurement with a tape measure (in centimetres) of the maximum circumference of the thigh
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ELODIE POUGOUE
Phone
+33238744086
Email
elodie.pougoue-touko@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu COULONGEAT, MD
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orléans
City
Orléans
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu COULONGEAT, MD
First Name & Middle Initial & Last Name & Degree
Matthieu COULONGEAT, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Patients

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