Physical Performance Decline in Older AdultsFATUS-OLDNCT07411547
Clinical Relevance of Ultrasound-based Intramuscular Fat Infiltration Assessment in Hospitalized Older Adults (FATUS-OLD)
An observational study of Physical Performance Decline in Older Adults and Sarcopenia, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Physical Performance Decline in Older Adults, Sarcopenia, Muscle Fat Infiltration
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2026to 21 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All participants undergo standardized clinical assessments and ultrasound-based muscle evaluations as part of routine rehabilitation follow-up.
Who may be able to join
- Age ≥ 75 years
- Hospitalized in rehabilitation day-hospital program
- Written informed consent
Who cannot join
- Moderate to severe neurocognitive disorders
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Anne-Sophie BOUREAU, 0244768535, annesophie.boureau@chu-nantes.fr
About this study
Official title: Clinical Relevance of Matrix-based Ultrasound Assessment of Intramuscular Fat Infiltration 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.
Read the 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.
- Keywords
- Sarcopenia, Older adults, Muscle quality, Intramuscular fat, Ultrasound imaging, Physical performance, Geriatric rehabilitation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | All participants undergo standardized clinical assessments and ultrasound-based muscle evaluations as part of routine rehabilitation follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (3)
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.
Measured: Baseline
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.
Measured: Baseline and 6 months
Occurrence of clinically significant events
Incidence of falls, loss of independence, rehospitalization, cognitive decline, institutionalization, and mortality.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start21 May 2026
- Primary completion21 Nov 2028 (estimated)
- Study completion21 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Performance Decline in Older AdultsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AGENCE NATIONALE DE RECHERCHE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411547
- Sponsor's protocol ID
- RC25_0301
- Other IDs
- 2025-A02297-42
- Acronym
- FATUS-OLD
- Status last verified
- Jun 2026
- First submitted
- 9 Feb 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of Matrix-based Ultrasound Assessment of Intramuscular Fat Infiltration in Hospitalized Older Adults (FATUS-OLD)
- ClinicalTrials.gov ID
- NCT07411547
- Acronym / sponsor ID
- FATUS-OLD / RC25_0301
- Keywords
- Sarcopenia, Older adults, Muscle quality, Intramuscular fat, Ultrasound imaging, Physical performance, Geriatric rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- AGENCE NATIONALE DE RECHERCHE
- Study start
- 21 May 2026 (actual)
- Primary completion
- 21 Nov 2028 (estimated)
- Study completion
- 21 Nov 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | –All participants undergo standardized clinical assessments and ultrasound-based muscle evaluations as part of routine rehabilitation follow-up. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All participants undergo standardized clinical assessments and ultrasound-based muscle evaluations as part of routine rehabilitation follow-up.
Key inclusion criteria (3 listed)
- Age ≥ 75 years
- Hospitalized in rehabilitation day-hospital program
- Written informed consent
Key exclusion criteria (2 listed)
- Moderate to severe neurocognitive disorders
- Inability to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Performance Decline in Older Adults and Sarcopenia, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Physical Performance Battery (SPPB) score (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.