NCT04753450

Brief Summary

The sarcopenia diagnosis is based on the muscle mass and on impaired physical performance. The emerging field of ultrasound assessment of muscle mass in older patients is based on 2d parameters with prediction equations for muscle mass. For the moment, validation of prediction equations in older adults with varying function and health is lacking. The study aims to evaluate correlation of muscle mass between 3D muscle mass measurement and DXA, in order to dispense with the prediction equation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.6 years

First QC Date

February 10, 2021

Last Update Submit

November 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 3D Correlation between muscle volume measured by 3D ultrasound and standard method : DXA results

    Correlation between muscle volume measured by 3D ultrasound and standard method : DXA results

    1 week

Secondary Outcomes (1)

  • 2D correlation between muscle volume measured by 2D ultrasound and standard method : DXA results

    1 week

Interventions

No intervention

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Older patients who agrees to participate to the study will undergo 3D ultrasound muscle mass measurement, 2D panoramic mode muscle mass measurement and biphotonic X-ray absorptiometry assessment, the same day. Correlation analysis will be done with the different measurement.

You may qualify if:

  • Patients over 75 years old
  • Osteoporosis diagnosis confirmed by Dual-energy X-ray Absorptiometry

You may not qualify if:

  • Neurocognitive disorders preventing the expression of informed consent
  • Patients who cannot undergo an examination in a static position
  • Lack of a measurement site (muscle resection or amputation)
  • Any state of dehydration or water inflation
  • Patient with legal protection measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, France

Location

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 15, 2021

Study Start

March 9, 2021

Primary Completion

October 19, 2022

Study Completion

October 19, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations