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Ultrasound (US) Measurement of Sarcopenia in the Elder Subject (MESSAGE)

Primary Purpose

Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound measurement
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcopenia

Eligibility Criteria

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

Inclusion Criteria:

  • Age 75 or older
  • SARC-F > 4
  • Decrease in muscle strength: grip strength <27 kg for men and <16 kg for women; and/or Chair stand test < 15 seconds
  • Patient affiliated or beneficiary of a social security plan
  • Patient who has signed informed consent beforehand

Exclusion Criteria:

  • Neurocognitive disorder preventing the expression of informed consent
  • Lack of a measurement site (muscle resection or amputation)
  • Impossibility or contraindication to strict dorsal and/or ventral decubitus
  • Any associated neuromuscular pathology that may alter muscle composition and trophicity
  • Wearing a pacemaker
  • Any state of water inflation or dehydration
  • History of surgery on the studied lower limb less than 6 months old
  • Patients protected by law under guardianship or under curate, or unable to participate in a clinical study under Article L. 1121-16 of the French Code of Public Health

Sites / Locations

  • University Hospital of NiceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

US measurement of sarcopenia

Arm Description

Outcomes

Primary Outcome Measures

Combinaison of US measurements
To determine the most relevant combination of ultrasound measurements, the investigators will assess the muscles thickness in centimeters.

Secondary Outcome Measures

Inter-operator reproductibility
To assess inter-operator reproducibility
Muscle elasticity
To explore whether muscle elasticity is a relevant ultrasound measure for assessing sarcopenia in an elderly geriatric population. Muscles elasticity will be assessed in meter/seconde.

Full Information

First Posted
April 7, 2021
Last Updated
July 26, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04842773
Brief Title
Ultrasound (US) Measurement of Sarcopenia in the Elder Subject
Acronym
MESSAGE
Official Title
MESSAge Study : Ultrasound Measurement of Sarcopenia in the Elder Subject
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
October 26, 2023 (Anticipated)
Study Completion Date
October 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

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

5. Study Description

Brief Summary
Sarcopenia is a generalized, progressive and multifactorial muscle impairment, causing multiple pathologies and their consequences such as falls, fractures, dependence, worsening of cognitive disorders and death. Interventions to combat the progression of sarcopenia should be introduced as soon as clinically suspected, based on functional tests to measure muscle strength. Diagnostic confirmation of sarcopenia can be done using several validated methods of estimating muscle mass: magnetic resonance imaging (MRI), computed tomography (CT), biphotonic absorptiometry (DEXA) or bio-impedanceometry. Their availability in clinical routine remains limited due to their high costs and/or lack of accessibility depending on the place of practice. On the other hand, there are certain pitfalls for carrying out these various examinations, in connection with several common clinical problems in the study population: mobility disorders and neurodegenerative disorders disabling for transport and access to the examination table for imaging examinations, hydration disorders distorting measures for bio-impedancetry. Previous studies suggest that ultrasound may be as effective a tool as previous methods for diagnostic confirmation of sarcopenia. Because of its non-invasive and non-irradiating nature, its affordability, its short duration of realization, its availability and its low constraints of realization, the ultrasound could help to remove some of the current limits to the diagnostic confirmation of sarcopenia. The investigators hypothesis is that ultrasound can be used to implement a simple and reliable protocol for assessing sarcopenia in the elderly. It could also be used to detect sarcopenia at an early stage ("presarcopenia") while the decrease in muscle mass is not yet accompanied by a decrease in skeletal muscle strength.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
US measurement of sarcopenia
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound measurement
Intervention Description
Ultrasound measurement of sarcopenia in an elderly population
Primary Outcome Measure Information:
Title
Combinaison of US measurements
Description
To determine the most relevant combination of ultrasound measurements, the investigators will assess the muscles thickness in centimeters.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Inter-operator reproductibility
Description
To assess inter-operator reproducibility
Time Frame
1 day
Title
Muscle elasticity
Description
To explore whether muscle elasticity is a relevant ultrasound measure for assessing sarcopenia in an elderly geriatric population. Muscles elasticity will be assessed in meter/seconde.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 75 or older SARC-F > 4 Decrease in muscle strength: grip strength <27 kg for men and <16 kg for women; and/or Chair stand test < 15 seconds Patient affiliated or beneficiary of a social security plan Patient who has signed informed consent beforehand Exclusion Criteria: Neurocognitive disorder preventing the expression of informed consent Lack of a measurement site (muscle resection or amputation) Impossibility or contraindication to strict dorsal and/or ventral decubitus Any associated neuromuscular pathology that may alter muscle composition and trophicity Wearing a pacemaker Any state of water inflation or dehydration History of surgery on the studied lower limb less than 6 months old Patients protected by law under guardianship or under curate, or unable to participate in a clinical study under Article L. 1121-16 of the French Code of Public Health
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emeline Michel
Phone
0492034399
Ext
+33
Email
michel.e2@chu-nice.fr
Facility Information:
Facility Name
University Hospital of Nice
City
Nice
State/Province
Provence Alpes Cote d'Azur
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emeline Michel
Phone
0492034194
Email
michel.e2@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Guillaume SACCO
First Name & Middle Initial & Last Name & Degree
Emeline MICHEL

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound (US) Measurement of Sarcopenia in the Elder Subject

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