Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04933097 |
| Other study ID # |
PA21032* |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 29, 2021 |
| Est. completion date |
May 16, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
CHU de Reims |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Evaluation of a new screening method for sarcopenia in rheumatoid arthritis
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:
- Presarcopenia when there is a decrease in strength or muscle mass alone,
- Sarcopenic obesity when there is, in addition to the decrease in IMMA, an increase in
the percentage of fat mass to 40% in women and 27% in men However, these tests are
expensive, radiating and difficult to access for the general population. For these
reasons, a screening algorithm is proposed by measuring hand grip strength, which is
correlated with the decrease in overall muscle mass and physical performance in the
general population.
The consequences of sarcopenia are numerous. In patients with severe sarcopenia, the risk of
falling is doubled, increasing the risk of hospitalisation and the length of hospital stays.
Severe sarcopenia is also associated with an earlier risk of death.
The prevalence of primary sarcopenia is between 15 and 20% in patients over 70 years of age,
40% after 80 years of age. In rheumatoid arthritis, Italian, Chinese, Japanese and Moroccan
cohorts report a prevalence of sarcopenia in RA ranging from 21 to 40.9% with a median age of
52.3 to 56.5 years in these studies. There is thus an overrepresentation of this condition
with an early age of onset compared to primary forms. In addition, there is pre-sarcopenia in
20% of cases.
This pre-sarcopenia could correspond to a window of opportunity for the management of these
patients, both in terms of diet and rehabilitation. Indeed, the new recommendations of the
European League Against Rheumatism concerning physical activity in inflammatory rheumatism
propose the combination of aerobic and resistance work in patients with inflammatory
rheumatism. However, when management is delayed, rehabilitation is sometimes no longer
possible.
The specific consequence of sarcopenia in rheumatoid arthritis is a significant functional
impact, with an increase in the Health Assessment Questionnaire (HAQ) score. In addition,
loss of muscle mass and function was highly correlated with a decrease in overall bone mass,
leading to a higher risk of osteoporotic fracture in this population. However, the method of
assessing this sarcopenia does not seem to be the most appropriate in this population. There
is a risk of overestimating the loss of strength through joint deformities. Indeed, one study
showed that hand grip strength was correlated with age in the general population as opposed
to a population of patients followed for RA. If this is not possible, the authors suggest
that isokinetic measurements of other muscle groups should be performed to identify patients
who may benefit from quantitative dynamometric muscle measurement.
There are several methods of assessing isokinetic strength. As muscle testing is very
operator dependent, these new standardised and reproducible measurement techniques are
expanding rapidly. There are two main types of dynamometry, isokinetic machines such as
CYBEX® and BIODEX® and hand dynamometers, with a good correlation between the two techniques.
Because of its low cost, portability and ease of use, this technique could justify wider use,
particularly in consultation. In this context of potential bias with overestimation of grip
strength, it would be useful to evaluate isokinetic measurement of other muscle groups to
assess which patients require quantitative muscle mass measurement.
However, no study has yet validated such a measure in rheumatoid arthritis. The hypothesis of
our work is that manual dynamometry on other muscle groups would be more reproducible and
reliable than grip force dynamometry for the detection of sarcopenia.
Primary endpoint:
Calculation of the sensitivity and specificity of quadriceps/triceps/biceps muscle strength
measurement by handheld isokinetic dynamometer in screening for sarcopenia versus gold
standard (DEXA whole body).
DEXA whole body is the gold standard method of measuring body compartments and allows the
diagnosis of sarcopenia (IMMA<7 in men and 5.5 in women).
Manual dynamometry allows isokinetic measurements of muscle strength on 3 muscle groups using
a manual measurement sensor of the Microfet2 ® type: quadriceps, triceps brachii, biceps
(results in newtons/m²).
Both examinations will be performed during the patient's visit to the day hospital and will
be interpreted blind to the results of each of these examinations.
Secondary endpoints:
1. Calculation of the intra-class correlation coefficient to assess inter-operator
agreement for manual dynamometry. To evaluate the concordance, isokinetic measurements
of muscle force on the 3 muscle groups using a manual measurement sensor such as
Microfet2 ® will be performed by 2 different operators.
2. Comparison of the sensitivity and specificity values of the JAMAR® and Microfet2®
dynamometer The isokinetic measurements of muscular force will be carried out using a
Microfet2 ® type manual measurement sensor at the level of the quadriceps, triceps
brachii, and biceps (results in newtons/m²) The measurement of grip strength will be
performed with Jamar® equipment as recommended by the EWGSOP.
DEXA whole body is the reference method for measuring body compartments and allows the
diagnosis of sarcopenia (IMMA<7 in men and 5.5 in women).
3. Identification of risk factors for sarcopenia (smoking, alcohol, corticosteroids,
duration of RA)
4. Description of comorbidities associated with sarcopenia (metabolic syndrome, cancer)
5. Impact on fatigue assessed by FSS questionnaire, HAQ assessment and SF 36
