Clinical Relevance of Ultrasound-based Intramuscular Fat Infiltration Assessment in Hospitalized Older Adults (FATUS-OLD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age75+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 75 years
Hospitalized in rehabilitation day-hospital program
Written informed consent
Disqualifiers
Moderate to severe neurocognitive disorders
Inability to comply with study procedures
Trial population
All participants undergo standardized clinical assessments and ultrasound-based muscle evaluations as part of routine rehabilitation follow-up.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
115 Participants
are grouped into 1 trial groupGroup A: Observational cohort
Trial outcomes
Primary outcomes
1
Change in Short Physical Performance Battery (SPPB) score
Difference between SPPB score at baseline and at 6 months, used to evaluate recovery of physical performance in relation to baseline intramuscular fat infiltration.
Time frame
Baseline to 6 monthsSecondary outcomes
1
Association between muscle volume and appendicular lean mass
Correlation between ultrasound-derived muscle volume (with and without correction for intramuscular fat infiltration) and appendicular lean mass measured by bioelectrical impedance analysis.
Time frame
Baseline2
Association between muscle volume and muscle strength
Relationship between muscle volume and maximal muscle strength for corresponding muscle groups, with and without correction for intramuscular fat infiltration.
Time frame
Baseline and 6 months3
Occurrence of clinically significant events
Incidence of falls, loss of independence, rehospitalization, cognitive decline, institutionalization, and mortality.
Time frame
Up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nantes University Hospital
Lead sponsor
AGENCE NATIONALE DE RECHERCHE
Collaborator
Source ClinicalTrials.gov