Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03740061 |
| Other study ID # |
SARCUS2 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2019 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
April 2021 |
| Source |
Universiteit Antwerpen |
| Contact |
Stany Perkisas, MD |
| Phone |
003232803539 |
| Email |
stany.perkisas[@]zna.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Traditionally, muscle mass - a part of the concept of sarcopenia - is measured by computed
tomography (CT) or dual-energy X-ray absorptiometry (DEXA) scan. These devices are not always
easily available in clinical practice and cannot be used bedside. An innovation in sarcopenia
is the assessment of muscle mass and quality with ultrasound. Because this device is much
more available and applicable in all patients, diagnosis of acute sarcopenia would be much
easier with ultrasound. Moreover, if other factors that contribute to accelerated decline in
muscle mass and function can be determinated, the sensiblisation and early screening for
acute sarcopenia in those individuals can hopefully prevent them from declining.
Description:
Methods Study design A prospective, multicenter, international observational study will be
conducted. The study is designed to determine the effect of hospitalisation due to acute
illness on the changes in muscle mass and muscle function. The secondary endpoint of the
study is to identify health related parameters associated with the development of acute
sarcopenia.
Subjects Inclusion criteria Patients admitted between the 1st of December 2018 until the 31th
of November 2019 will be eligible for inclusion. Included wards for admission are: internal
medicine, acute geriatrics, orthogeriatrics and rehabilitation. Age limit will be set on 65
years and older.
Exclusion criteria Patients on dialysis will be excluded because of possible metabolic
features. Individuals with paresis of the lower limbs or hemiparesis due to a stroke will be
excluded because of neurological involvement that can influence the results. Hypo-or
hyperthyroid patients will be excluded because of the role of thyroid hormones in muscle
homeostasis. Pitting oedema of the legs (due to heart failure, anasarca oedema, renal failure
or liver cirrhosis) or severely dehydrated patients will be excluded because fluid shifts
could influence the ultrasound measurement results. Because of possible previous changes in
muscle mass, architecture and function, patients with systemic connective tissue disorders,
myositis, calcification and ossification of muscle, systemic atrophies primarily affecting
the central nervous system and demyelinating diseases of the central nervous system will be
excluded. Patients using chronic oral corticosteroids will be excluded.
Settings and locations The study will be a multicenter study held in different university and
tertiary teaching hospitals throughout Europe.
Measurements
Patient characteristics Date of birth, gender, height and weight will be registered. If the
patient is bedridden, weight can be measured through either weight chairs or weight measuring
lifts. Height will be estimated using the ulna length or knee height. Date of admission and
discharge will be noted. The home care setting of the patient will be registered. The main
reason of hospital admission will be registered.
Comorbidities on admission will be registered through the Cumulative Illness Rating Scale for
Geriatrics (CIRS-G). The CIRS-G was designed to estimate the survival of elderly persons,
assessing disease severity using a score from 0 to 4 in 14 different categories of organ
systems: cardiac, vascular, hematological, respiratory, ophthalmological and
otorhinolaryngological, upper gastro-intestinal, lower gastro-intestinal, hepatic and
pancreatic, renal, genito-urinary, musculoskeletal and tegumental, neurological,
endocrine/metabolic/breast and psychiatric. Score '0' stands for 'no problem affecting that
system', score '1' stands for 'current mild problem or past significant problem', score '2'
stands for 'moderate disability or morbidity', score '3' stands for 'severe problem' and
score '4' stands for 'extremely severe problem'.
Laboratory values that will be checked are either nutritional through albumin and prealbumin,
inflammatory through C-reactive protein (CRP) and white blood cell count, and the measurement
of 25-hydroxyvitamin D (25-OH-vitamin D). Blood samples will be collected on day of
admission. Laboratory values that are not expected to fluctuate strongly (albumin,
pre-albumin, 25-OH-vitamin D) will be taken within the first 5 days of admission.
Muscle mass In order to obtain reliable and consistent measurements, all ultrasonography will
be done by an ultrasonographist that is trained to perform the measurements proposed. For the
measurements, a linear probe of 5 cm width will be used. Frequency of the beam will be set on
12 MHz.
Patients should not have had any physical exercise in the 30 minutes before the measurement.
Muscles should be completely relaxed and patients should be placed in the supine position,
with hips in neutral position and knees fully extended. The dominant leg will be taken for
the measurements. To calculate the relative muscle thickness values, the total length of
muscle will be noted.
Ultrasonographic data of the four bellies of the quadriceps muscle (rectus femoris, vastus
lateralis, vastus medialis, vastus intermedius) will be taken. Measuring points will be
specified according to the propositions of the SARCUS-working group. Muscle thickness,
fascicle length, pennation angle, muscle cross-sectional area and echo-intensity of all
muscles listed will be taken.
The first measurement will be taken as early as possible within 48 hours after admission at
the latest. Follow-up measurements will be taken according to the type of ward the patient is
admitted to. For patients that are expected to be hospitalized for a limited time (<5 days),
the follow-up measurement will be done 3 days after initial measurement. For patients that
are expected to be hospitalized for a longer time (>7 days), measurements will be repeated 7
days after initial measurement, to be repeated after another 7 days as long as the patient is
hospitalized.
Muscle strength and function Muscle strength will be measured through hand grip strength
using a Jamar dynamometer, using the Southampton protocol. The first measurement will be
taken as early as possible within 48 hours after admission at the latest. Follow-up
measurements will be taken according to the type of ward the patient is admitted to. For
patients that are expected to be hospitalized for a limited time (<5 days), the follow-up
measurement will be done 3 days after initial measurement. For patients that are expected to
be hospitalized for a longer time (>7 days), measurements will be repeated 7 days after
initial measurement, to be repeated after another 7 days as long as the patient is
hospitalized. Measurement will be done directly after the ultrasonographic assessment. If
feasible, muscle function will be measured through gait speed, using the 4-meter walking test
at usual gait speed. In case of those bedridden, gait speed will not be measured.
In-hospital activity Registration of activity level during hospitalisation will be performed
by means of pedometers in those centers that have access to these devices. Both amount of
steps and step length will be noted, and total walked distance per day can hereby be
calculated.
Nutritional status Nutritional state of the patient will be registered through the
Mini-Nutritional Assessment - Short Form (MNA-SF). For diagnosis of malnutrition, the new
Global Leadership Initiative on Malnutrition (GLIM)-criteria will be used.
Questionnaires The SARC-F and FRAIL-scale will be completed as routine screening
questionnaires for sarcopenia and frailty, respectively. The SAR-QOL questionnaire will be
used to evaluate the self-reported quality of life.
Statistical analysis Databases will be kept up in a Microsoft Access database. Statistical
analysis will be done by using SPSS Statistics version 24. Descriptive analyses will be used
for determining the clinical and demographic characteristics. A Kolmogorov-Smirnov test will
be used to verify the normal distribution of the different variables. Further statistical
analyses will be performed by Chi Square test, Fisher exact, Mann-Whitney U test or Fisher
exact test, depending on the distribution and the nature of the variables analysed. P-values
of ≤0.05 will be considered statistically significant.
