Rheumatoid ArthritisSARCO-RANCT04933097
Evaluation of a New Screening Method for Sarcopenia in Rheumatoid Arthritis
A study testing Microfet2® in people with Rheumatoid Arthritis, run by CHU de Reims at 1 site in France.
Trial summary
Evaluation of a new screening method for sarcopenia in rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Microfet2®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2021to 16 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis defined according to ACR/EULAR 2010 criteria,
- Follow-up at the University Hospital of Reims,
- Signed consent
Who cannot join
- Inability to perform a functional test (walking test)
- Patient under legal protection
- Patients not affiliated to the social security system
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of a new screening method for sarcopenia in rheumatoid arthritis
Read the 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:
- 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:
- 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.
- 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).
- Identification of risk factors for sarcopenia (smoking, alcohol, corticosteroids, duration of RA)
- Description of comorbidities associated with sarcopenia (metabolic syndrome, cancer)
- Impact on fatigue assessed by FSS questionnaire, HAQ assessment and SF 36
- Conditions
- Rheumatoid Arthritis
- Being tested
- Microfet2®
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfet2®Device
Conducting a day hospitalization including analyses:
- Quantitative muscular analysis by measuring the DEXA of the whole body, the reference method for measuring body compartments and allowing the diagnosis of sarcopenia (IMMA<7 in men and 5.5 in women)
- Qualitative muscular analysis:
- isokinetic measurement of muscular strength carried out on 3 muscle groups using a manual measurement sensor such as Microfet2 ® : quadriceps, triceps brachii, biceps
- measurement of grip strength using Jamar® equipment validated as recommended by the EWGSOP
- a walking test to assess the functional impact of sarcopenia and its severity
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenia | Experimental | Only one arm with the sarcopenia assessment. Receives: Device: Microfet2® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadricepsmeasurement
The three measurements will be performed by two different operators and the results will be expressed in Newton/m.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start29 Jul 2021
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933097
- Sponsor's protocol ID
- PA21032*
- Acronym
- SARCO-RA
- Status last verified
- May 2024
- First submitted
- 11 Jun 2021
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Screening Method for Sarcopenia in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04933097
- Acronym / sponsor ID
- SARCO-RA / PA21032*
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 21 Jun 2021 (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.
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:
- 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:
- 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.
- 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).
- Identification of risk factors for sarcopenia (smoking, alcohol, corticosteroids, duration of RA)
- Description of comorbidities associated with sarcopenia (metabolic syndrome, cancer)
- Impact on fatigue assessed by FSS questionnaire, HAQ assessment and SF 36
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarcopenia | Experimental | Device: Microfet2®Only one arm with the sarcopenia assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Rheumatoid arthritis defined according to ACR/EULAR 2010 criteria,
- Follow-up at the University Hospital of Reims,
- Signed consent
Key exclusion criteria (4 listed)
- Inability to perform a functional test (walking test)
- Patient under legal protection
- Patients not affiliated to the social security system
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microfet2®Conducting a day hospitalization including analyses: 1. Quantitative muscular analysis by measuring the DEXA of the whole body, the reference method for measuring body compartments and allowing the diagnosis of sarcopenia (IMMA<7 in men and 5.5 in women) 2. Qualitative muscular analysis: * isokinetic measurement of muscular strength carried out on 3 muscle groups using a manual measurement sensor such as Microfet2 ® : quadriceps, triceps brachii, biceps * measurement of grip strength using Jamar® equipment validated as recommended by the EWGSOP * a walking test to assess the functional impact of sarcopenia and its severity | Device | Sarcopenia |
Primary outcome
Quadricepsmeasurement
Time frame: Day 0
The three measurements will be performed by two different operators and the results will be expressed in Newton/m.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfet2® in people with Rheumatoid Arthritis, run by CHU de Reims 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 4 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: finished, as of the sponsor's last update on 17 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadricepsmeasurement (time frame: Day 0). 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 17 May 2024.