NCT07011030

Brief Summary

Sarcopenia is defined as the loss of muscle strength and mass associated with aging and is one of the main causes of frailty in older people, and therefore of their ability to age gracefully. Given the aging of the French population, the diagnosis and management of this condition is a major public health issue and, in this context, it is therefore necessary to be able to quickly assess people's skeletal muscle mass. In its recommendations, French National Authority for Health recommends the use osteodensitometry and bioimpedance analysis (BIA) to assess skeletal muscle mass in the limbs for the purpose of diagnosing sarcopenia. Traditionally, BIA assessment is performed while lying down using adhesive electrodes placed on the hands and feet. The Biody XpertZM3 is a BIA device that allows seated measurement using integrated electrodes, enabling skeletal muscle mass to be assessed by bioimpedance analysis without the use of adhesive electrodes. However, the measurement position could alter the impedances measured and therefore the results obtained compared to other devices on the market as well as osteodensitometer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 23, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2025

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

May 30, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

sarcopeniaelderlybioimpedance analysisosteodensitometry

Outcome Measures

Primary Outcomes (1)

  • Appendicular skeletal muscle mass

    Comparison of skeletal muscle mass of the limbs (in kg) obtained by bioimpedance analysis using integrated electrodes and using osteodensitometry

    day 0

Study Arms (1)

Skeletal muscle mass measurement

EXPERIMENTAL

Patients will undergo a: * Bioimpedance analysis with the Biody XpertZM 3 (bioimpedance device with integrated electrodes ) * Osteodensitometer analysis with the SRATOS DR

Other: Measure of skeletal muscle mass

Interventions

Bioimpedance analysis with integrated electrodes and osteodensitometry examination

Skeletal muscle mass measurement

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women aged 60 or over already receiving care at the Day Hospital of the Rehabilitation, Independence and Aging Center or the Frailty Platform of the Rehabilitation, Independence and Aging Center.
  • Patients affiliated with or covered by a social security system.
  • Patients who have signed an informed consent form in advance.

You may not qualify if:

  • Vulnerable persons as defined in Articles L1121-5 to -8
  • People with pacemakers, implantable defibrillators, or other electronic medical devices
  • Musculoskeletal disorders that prevent bioimpedance measurement in a seated position
  • Any condition of fluid retention or dehydration
  • Absence of a measurement site (muscle resection or amputation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, Alpes-Maritimes, 06000, France

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Frédéric CHORIN, PhD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 8, 2025

Study Start

September 23, 2025

Primary Completion

December 4, 2025

Study Completion

December 4, 2025

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations