Sarcopenia Clinical Trial
Official title:
Can the Sit-to-Stand Test be Used as a Screening Tool to Detect Sarcopenia in Community-dwelling Older People?
A common condition associated with ageing is sarcopenia, which is a progressive decrease in
muscle mass. Sarcopenia is associated with adverse outcomes including increased mortality,
and places a major burden on healthcare spending, with the annual cost of sarcopenia in the
United States exceeding that of osteoporosis and hip fracture. In the UK, the prevalence of
sarcopenia in community-dwelling older people has been estimated at 5% for men and 8% for
women. Current guidelines for sarcopenia diagnosis require muscle mass to be measured using
costly devices such as Dual Energy X-ray Absorptiometry (DXA) and Magnetic Resonance Imaging
(MRI). Previous research has found strong relationships between the sit-to-stand (STS) test
and both muscle mass and muscle strength. This pilot study aims to examine this relationship
in community-dwelling older people to develop predictive equations for initial screening of
sarcopenia.
Forty subjects will be tested using the diagnostic criteria developed by the European Working
Group on Sarcopenia in Older People (EWGSOP). Muscle mass will be measured using the DXA and
diagnostic ultrasound. Muscle strength will be measured using isokinetic dynamometer,
handgrip dynamometry, and hand-held dynamometry. Functional performance will be measured
using the Timed-up-and-Go and gait velocity, and the STS. Subjects will perform two variants
of the STS; the five times STS (5STS), which requires subjects to perform five consecutive
STS movements as quick as possible, and the 30-second STS (30STS), which requires subjects to
perform as many STS movements as possible in 30 seconds. All testing will be completed in a
single session lasting 90 minutes for each subject. Testing will be performed at the
University of Bedfordshire Polhill Campus. Subject recruitment will be recruited using
advertisement posters and word of mouth.
Loss of function and mobility becomes an increasing concern as we age. Life expectancy is
continuing to increase, which in turn leads to age-related diseases and syndromes becoming
more common, complex and costly. Sarcopenia is the deficiency of muscle and this refers to
the gradual loss of skeletal muscle mass and strength that occurs with advancing age This
age-related disease is now understood as a major clinical problem for the elderly and it is
becoming a public health issue in today's society.
The European Working Group on Sarcopenia in Older People (EWGSOP) has developed a clinical
and practical definition and a diagnostic criterion for age-related sarcopenia. They define
sarcopenia as "a syndrome characterised by progressive and generalised loss of skeletal
muscle mass and strength with a risk of adverse outcomes". The EWGSOP further develop their
definition of sarcopenia into two different categories and three different stages. The two
categories are known as primary sarcopenia and secondary sarcopenia. Primary or age-related
sarcopenia is when there is no other cause evident except ageing. Whereas secondary
sarcopenia is when there are one or more other causes, such as activity-related,
disease-related or nutrition-related. The three stages of sarcopenia reflect the severity of
the condition; these are known as presarcopenia, sarcopenia and severe sarcopenia. The
presarcopenia stage is described as having low muscle mass, without influencing muscle
strength or physical performance. The sarcopenia stage is indicated by again having low
muscle mass plus either having low muscle strength or poor physical performance. The severe
sarcopenia stage is characterised by meeting all three criteria of the definition; low muscle
mass, low muscle strength and poor physical performance. The EWGSOP specify that the
measurable variables of sarcopenia are muscle mass, muscle strength and physical performance.
The challenge they raised is the difficulty determining which methods are best to accurately
measure these variables.
The EWGSOP indicate that muscle mass is best measured using body imaging techniques such as
magnetic resonance imaging (MRI) or computer-tomography (CT). Both MRI and CT scans are known
as the gold standards for measuring muscle mass within research. However, they are costly
procedures that are not always freely available. Muscle mass can also be measured through
dual energy X-ray absorptiometry (DEXA), for determining the presence of and formulating a
diagnosis of sarcopenia. DEXA is based on the measurement of X-ray transmission crossing
human tissues. The radiation energies produced by the DEXA are variably attenuated, either
scattered or absorbed, by the anatomical structures within the body, dependent on the
intensity of the energy and the density and thickness of the human tissues. DEXA enables
measurements of fat mass (FM), lean mass (LM) and bone mineral content (BMC) and can assess
body masses and bone mineral density (BMD) on a regional and a whole-body basis, whilst
exposing only minimal radiation to the patient. According to the EWGSOP, DEXA is a preferred
alternative method for measuring muscle mass within research and clinical use. However, it
has been reported that measures of muscle mass from DEXA scans do not seem to be accurate,
with a site-specific assessment of loss of muscle mass, using ultrasound-based assessment
suggested. Ultrasound has been reported to be an effective and non-invasive tool to determine
muscle wasting, potentially leading to an earlier and more accurate detection of sarcopenia.
Measures of muscle mass are not as good a predictor of physical capability as muscle
strength. Lower limb muscle strength is more relevant for gait and physical function than
upper limb muscle strength. However, the EWGSOP recognise handgrip strength as the most
widely used method for measuring muscle strength to screen for sarcopenia. Handgrip strength
is strongly related with lower extremity muscle power, knee extension torque and calf
cross-sectional muscle area. Consequently, it has been documented that muscle power
deteriorates earlier and quicker than muscle strength in older populations. Therefore, a
measure of muscle power could be more beneficial in the diagnosis of sarcopenia as older
people lose power quicker than they do strength. Isokinetic dynamometers (IKD) are a commonly
used tool and are recognised as a gold standard measure of muscle power and strength. IKD's
measure force dynamically through a specified range of motion whilst allowing the velocity of
the movement to be controlled and measured. It is recognised as a popular method to assess
muscle function in both clinical and research settings. However, due to IKD's not being
portable and are not always accessible, there has been a rise in the use of hand-held
dynamometry (HHD) to assess isometric muscle strength. It has been reported that HHD is a
simple and inexpensive and a reliable and valid assessment tool for measuring strength,
particularity in older adults. The use of isometric strength testing may be more suitable for
older adults if there is a limited range of joint motion and if joint pain is prevalent,
concentric actions may be challenging.
The importance of using physical performance measures within clinical geriatrics as well as
ageing research has also been documented. There are many tests of physical performance that
have been validated and are widely used. The EWGSOP identified popular methods for evaluating
physical performance. These include the Short Physical Performance Battery (SPPB), usual gait
speed (GS), the timed get-up-and-go (TUG) test and the stair climb power test. The ability to
rise from a chair has been used in clinical evaluations and on-going assessments for decades.
This everyday task was standardised and developed into the 'timed-stands' test. This test was
initially designed to measure functional strength of the lower extremities as participants
completed 10 timed-stands. Variations of this sit-to-stand (STS) task have evolved and now
one of the most commonly used tools for clinical evaluation of physical performance is the
Five-Times-Sit-To-Stand (5STS) test. The 5STS, requires the participant to stand up and sit
down from a chair five times, with performance taken as the time to complete the test. The
STS task was modified further, with a standardised 'time' protocol of 30 seconds (30sSTS),
requiring the participant to stand up and sit down as many times as possible within 30
seconds. They reasoned the use of the 30sSTS instead of participants performing a
predetermined number of repetitions (e.g. 5STS, 10STS) to assess a wider range of ability.
Moreover, the 5STS and potentially even the 10STS can be recorded as the participant performs
the 30sSTS. In addition to functional performance, the STS task could also be used to
estimate muscle power and even muscle mass. In a recent study, an accurate estimation of
lower-limb muscle power was obtained using a simple regression equation in which only body
weight and the number of STS performed in 20 seconds, of a 30-second trial were used. Another
study had also reported a good estimation of muscle mass obtained from an MRI, again using a
simple regression equation in which only three basic variables were used, namely leg length,
body mass and the time taken for a single STS movement.
Research Aim The aim of this study is to validate the use of the Sit-To-Stand task as a
measure of muscle mass, muscle strength and power and physical performance in screening for
sarcopenia compared to gold standard measures, in older adults aged 65 years and over.
Research Objectives
1. Suitability of the Sit-To-Stand task as a measure of muscle mass in comparison to the
gold standard equivalents, the dual energy x-ray absorptiometry scan and diagnostic
ultrasound.
2. Suitability of the Sit-To-Stand task as a measure of muscle strength and power in
comparison to the gold standard equivalents, the isokinetic dynamometer the hand-grip
strength dynamometer and the hand-held dynamometer.
3. Suitability of the Sit-To-Stand task as a measure of physical performance in comparison
to other well used physical function tests, the Timed-Up-and-Go and gait.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06287502 -
Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
|
N/A | |
Recruiting |
NCT05063279 -
RELIEF - Resistance Training for Life
|
N/A | |
Completed |
NCT03644030 -
Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
|
||
Recruiting |
NCT06143592 -
Inspiratory Muscle Training on Balance, Falls and Diaphragm Thickness in the Elderly
|
N/A | |
Terminated |
NCT04350762 -
Nutritional Supplementation in the Elderly With Weight Loss
|
N/A | |
Enrolling by invitation |
NCT05953116 -
Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study
|
N/A | |
Recruiting |
NCT04028206 -
Resistance Exercise or Vibration With HMB for Sarcopenia
|
N/A | |
Enrolling by invitation |
NCT03297632 -
Improving Muscle Strength, Mass and Physical Function in Older Adults
|
N/A | |
Completed |
NCT04015479 -
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults
|
N/A | |
Completed |
NCT03234920 -
Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation After Liver Transplantation
|
N/A | |
Recruiting |
NCT03998202 -
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
|
||
Recruiting |
NCT04717869 -
Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
|
||
Completed |
NCT05497687 -
Strength-building Lifestyle-integrated Intervention
|
N/A | |
Completed |
NCT03119610 -
The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
|
Phase 1/Phase 2 | |
Recruiting |
NCT05711095 -
The Anabolic Properties of Fortified Plant-based Protein in Older People
|
N/A | |
Recruiting |
NCT05008770 -
Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
|
||
Not yet recruiting |
NCT05860556 -
Sustainable Eating Pattern to Limit Malnutrition in Older Adults
|
||
Recruiting |
NCT04545268 -
Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
|
N/A | |
Recruiting |
NCT04522609 -
Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant
|
N/A | |
Recruiting |
NCT03160326 -
The QUALITY Vets Project: Muscle Quality and Kidney Disease
|