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Clinical Relevance of Ultrasound-based Intramuscular Fat Infiltration Assessment in Hospitalized Older Adults (FATUS-OLD)

Clinical Relevance of Matrix-based Ultrasound Assessment of Intramuscular Fat Infiltration in Hospitalized Older Adults (FATUS-OLD)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07411547
Acronym
FATUS-OLD
Enrollment
115
Registered
2026-02-17
Start date
2026-05-21
Completion date
2028-11-21
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Fat Infiltration, Physical Performance Decline in Older Adults, Sarcopenia

Keywords

Sarcopenia, Older adults, Muscle quality, Intramuscular fat, Ultrasound imaging, Physical performance, Geriatric rehabilitation

Brief summary

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.

Interventions

None listed

Sponsors

Nantes University Hospital
Lead SponsorOTHER
AGENCE NATIONALE DE RECHERCHE
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Short Physical Performance Battery (SPPB) scoreBaseline to 6 monthsDifference between SPPB score at baseline and at 6 months, used to evaluate recovery of physical performance in relation to baseline intramuscular fat infiltration.

Secondary

MeasureTime frameDescription
Association between muscle volume and appendicular lean massBaselineCorrelation between ultrasound-derived muscle volume (with and without correction for intramuscular fat infiltration) and appendicular lean mass measured by bioelectrical impedance analysis.
Association between muscle volume and muscle strengthBaseline and 6 monthsRelationship between muscle volume and maximal muscle strength for corresponding muscle groups, with and without correction for intramuscular fat infiltration.
Occurrence of clinically significant eventsUp to 6 monthsIncidence of falls, loss of independence, rehospitalization, cognitive decline, institutionalization, and mortality.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026