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NCT Number: NCT07411547

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

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.

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Key information

Conditions

Physical Performance Decline in Older Adults Atrophy Muscle Fat Infiltration Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44093, France

Location status: Recruiting

Location contact

Anne-Sophie BOUREAU

CONTACT

[email protected]

0244768535

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Short Physical Performance Battery (SPPB) score

    Time frame: Baseline to 6 months

    Difference between SPPB score at baseline and at 6 months, used to evaluate recovery of physical performance in relation to baseline intramuscular fat infiltration.

Secondary outcomes

  1. Association between muscle volume and appendicular lean mass

    Time frame: Baseline

    Correlation between ultrasound-derived muscle volume (with and without correction for intramuscular fat infiltration) and appendicular lean mass measured by bioelectrical impedance analysis.

  2. Association between muscle volume and muscle strength

    Time frame: Baseline and 6 months

    Relationship between muscle volume and maximal muscle strength for corresponding muscle groups, with and without correction for intramuscular fat infiltration.

  3. Occurrence of clinically significant events

    Time frame: Up to 6 months

    Incidence of falls, loss of independence, rehospitalization, cognitive decline, institutionalization, and mortality.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • AGENCE NATIONALE DE RECHERCHE

Registry information

Official study title

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

Acronym: FATUS-OLD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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