Clinical Relevance of Ultrasound-based Intramuscular Fat Infiltration Assessment in Hospitalized Older Adults (FATUS-OLD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Physical Performance Decline in Older Adults, Sarcopenia, Muscle Fat Infiltration. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Relevance of Matrix-based Ultrasound Assessment of Intramuscular Fat Infiltration in Hospitalized Older Adults (FATUS-OLD)
Overview
Sarcopenia in older adults is associated not only with loss of muscle mass but also with deterioration of muscle quality, particularly intramuscular fat infiltration. While muscle mass is commonly assessed, muscle quality remains insufficiently explored in routine clinical practice. The FATUS-OLD study aims to evaluate the clinical relevance of a novel ultrasound-based multiparametric approach to assess intramuscular fat infiltration and muscle volume in hospitalized older adults undergoing rehabilitation. The main hypothesis is that higher intramuscular fat infiltration at baseline is associated with poorer recovery of physical performance at 6 months, independently of muscle volume. This non-invasive, rapid, and radiation-free imaging approach could improve sarcopenia phenotyping and help identify new prognostic biomarkers for clinical follow-up and future interventional trials.
Detailed description
FATUS-OLD is a prospective, monocentric, open-label, non-randomized observational study conducted at Nantes University Hospital. The study includes older adults aged 75 years and older hospitalized in a rehabilitation day-hospital program for gait or balance disorders.
Participants undergo ultrasound assessments of skeletal muscle using a CE-marked ultrasound device capable of measuring muscle volume and intramuscular fat infiltration through matrix-based analysis. Measurements are performed at baseline and during follow-up.
The primary objective is to assess the prognostic value of baseline intramuscular fat infiltration on physical performance recovery at 6 months, evaluated using the Short Physical Performance Battery (SPPB). Secondary objectives include the relationship between muscle volume, muscle quality, muscle strength, appendicular lean mass measured by bioelectrical impedance analysis, and clinically significant events such as falls, loss of independence, rehospitalization, and mortality.
The study is exploratory and aims to validate innovative ultrasound-derived biomarkers of muscle quality in a real-life geriatric population.
Primary outcome measures
- Change in Short Physical Performance Battery (SPPB) score [Time frame: Baseline to 6 months]
Secondary outcome measures (3)
- Association between muscle volume and appendicular lean mass [Time frame: Baseline]
- Association between muscle volume and muscle strength [Time frame: Baseline and 6 months]
- Occurrence of clinically significant events [Time frame: Up to 6 months]
Eligibility criteria
Inclusion criteria
- Age ≥ 75 years
- Hospitalized in rehabilitation day-hospital program
- Written informed consent
Exclusion criteria
- Moderate to severe neurocognitive disorders
- Inability to comply with study procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- CHU de Nantes — Nantes
Identifiers
NCT: NCT07411547 · RC25_0301 · 2025-A02297-42