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

NCT07411547 | Not Yet Recruiting

• 2 other identifiers: RC25_03012025-A02297-42
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

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.

  Baseline to 6 months

Secondary Outcomes (3)

• Association between muscle volume and appendicular lean mass

  Baseline

• Association between muscle volume and muscle strength

  Baseline and 6 months

• Occurrence of clinically significant events

  Up to 6 months

Study Arms (1)

Observational cohort

All participants undergo standardized clinical assessments and ultrasound-based muscle evaluations as part of routine rehabilitation follow-up.

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants undergo standardized clinical assessments and ultrasound-based muscle evaluations as part of routine rehabilitation follow-up.

You may qualify if:

• Age ≥ 75 years
• Hospitalized in rehabilitation day-hospital program
• Written informed consent

You may not qualify if:

• Moderate to severe neurocognitive disorders
• Inability to comply with study procedures

Sponsors & Collaborators

• Nantes University Hospital: lead
• AGENCE NATIONALE DE RECHERCHE: collaborator

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 2, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02