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
About this trial
This is an interventional diagnostic trial for Sarcopenia
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
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
NCT ID
NCT04842773
First Posted
April 7, 2021
Last Updated
July 26, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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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