Skip to main content
Clinical Trials/NCT04933097
NCT04933097CompletedNot Applicable

Evaluation of a New Screening Method for Sarcopenia in Rheumatoid Arthritis

CHU de Reims1 site in 1 country164 target enrollmentStarted: July 29, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
164
Locations
1
Primary Endpoint
Quadricepsmeasurement

Study Overview

Brief Summary

Evaluation of a new screening method for sarcopenia in rheumatoid arthritis

Detailed Description

Rheumatoid arthritis (RA) is the most common inflammatory rheumatic disease, affecting 0.4-0.8% of the population. This inflammatory rheumatism leads to progressive, bilateral and symmetrical joint destruction, predominantly in the hands, which is responsible for significant functional repercussions, a sedentary lifestyle and a reduction in physical capacities leading to the onset of comorbidities. Among these comorbidities, sarcopenia is an emerging concept.

Sarcopenia is defined as a decrease in the quality and quantity of a person's muscles. It can be primary, and therefore due to physiological ageing, or secondary to a chronic disease such as inflammatory rheumatism. The definition of sarcopenia has become consensual since the 2019 European Working group on Sarcopenia in Older People (EWGSOP) recommendations and is characterised by:

  • A decrease in strength. It is assessed by the grip test with a threshold of 27 kg in men and 16 kg in women. When this manual grip measurement is not possible, the authors advise measurement on an isokinetic device.
  • a decrease in overall muscle mass. This is assessed either by dual energy X-ray absorptiometry (DEXA whole body, the reference technique) and defined by a decrease in the appendicular muscle mass index (AMMI) < 7 kg/m² in men and < 5.5 kg/m² in women (AMMI corresponds to the lean mass of the 4 limbs in relation to the height for Europeans); or on the scanographic measurement of the surface of the psoas muscle at L3.
  • a decrease in muscular performance. This last point makes it possible to evaluate the severity of this sarcopenia. Muscular performance is assessed by walking speed and/or tests combining balance and walking such as the short physical performance battery test (SPPB) or the timed up and go (TUG).

The diagnosis of sarcopenia is certain when there is a decrease in muscle mass; it is characterised as severe when there is a decrease in physical performance.

Two other concepts are associated:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Rheumatoid arthritis defined according to ACR/EULAR 2010 criteria,
  • •Follow-up at the University Hospital of Reims,
  • •Signed consent

Exclusion Criteria

  • •Inability to perform a functional test (walking test)
  • •Patient under legal protection
  • •Patients not affiliated to the social security system
  • •Pregnant women

Arms & Interventions

Sarcopenia

Experimental

Only one arm with the sarcopenia assessment.

Intervention: Microfet2® (Device)

Outcomes

Primary Outcomes

Quadricepsmeasurement

Time Frame: Day 0

The three measurements will be performed by two different operators and the results will be expressed in Newton/m.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials