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Porvoo sarcopenia and nutrition trial: Effects of protein supplementation on functional performance in home-dwelling sarcopenic older people - study protocol for a randomized controlled trial

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Background: Age-related muscle loss (that is, sarcopenia) is a common health problem among older people. Physical exercise and dietary protein have been emphasized in prevention and treatment of sarcopenia. Rigorous trials investigating the effects of protein supplementation on physical performance in sarcopenic populations are still scarce. The aim of this study is to investigate the effects of protein supplementation along with simple home-based exercises on physical performance among home-dwelling sarcopenic older people. Methods/design: During 2012 the entire 75 and older population (N = 3,275) living in Porvoo, Finland was contacted via a postal questionnaire. Persons at risk of sarcopenia are screened with hand grip strength and gait speed. Poorly performing persons are further examined by segmental bioimpendance spectroscopy to determine their skeletal muscle index. Sarcopenic patients (target N = 250) will be enrolled in a 12-month randomized controlled trial with three arms: 1) no supplementation, 2) protein supplementation (20 grams twice a day), and 3) isocaloric placebo. All the participants will receive instructions on simple home-based exercises, dietary protein, and vitamin D supplementation (20 μg/d). The recruitment of patients will be completed during 2013. The primary endpoint of the trial is the change in short physical performance battery score and percentage of patients maintaining or improving their physical performance. Secondary endpoints will be, among other things, changes in muscle functions, nutritional status, body composition, cognition, quality of life, use of health care services, falls, and mortality. The assessment times will be 0, 6, 12 and 24 months. Discussion: To our knowledge, this is the first large scale randomized controlled trial among community dwelling older people with sarcopenia that focuses on the effects of protein supplementation on physical performance. Trial registration: ACTRN12612001253897, date of registration 28 October 2012, first patient was randomized 11 April 2012.
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S T U D Y P R O T O C O L Open Access
Porvoo sarcopenia and nutrition trial: effects of
protein supplementation on functional
performance in home-dwelling sarcopenic older
people - study protocol for a randomized
controlled trial
Mikko P Bjorkman
1*
, Merja H Suominen
2
, Kaisu H Pitkälä
3
, Harriet U Finne-Soveri
4
and Reijo S Tilvis
1
Abstract
Background: Age-related muscle loss (that is, sarcopenia) is a common health problem among older people.
Physical exercise and dietary protein have been emphasized in prevention and treatment of sarcopenia. Rigorous
trials investigating the effects of protein supplementation on physical performance in sarcopenic populations are
still scarce. The aim of this study is to investigate the effects of protein supplementation along with simple
home-based exercises on physical performance among home-dwelling sarcopenic older people.
Methods/Design: During 2012 the entire 75 and older population (N = 3,275) living in Porvoo, Finland was
contacted via a postal questionnaire. Persons at risk of sarcopenia are screened with hand grip strength and gait
speed. Poorly performing persons are further examined by segmental bioimpendance spectroscopy to determine
their skeletal muscle index. Sarcopenic patients (target N = 250) will be enrolled in a 12-month randomized
controlled trial with three arms: 1) no supplementation, 2) protein supplementation (20 grams twice a day), and 3)
isocaloric placebo. All the participants will receive instructions on simple home-based exercises, dietary protein, and
vitamin D supplementation (20 μg/d). The recruitment of patients will be completed during 2013. The primary
endpoint of the trial is the change in short physical performance battery score and percentage of patients
maintaining or improving their physical performance. Secondary endpoints will be, among other things, changes in
muscle functions, nutritional status, body composition, cognition, quality of life, use of health care services, falls, and
mortality. The assessment times will be 0, 6, 12 and 24 months.
Discussion: To our knowledge, this is the first large scale randomized controlled trial among community dwelling
older people with sarcopenia that focuses on the effects of protein supplementation on physical performance.
Trial registration: ACTRN12612001253897, date of registration 28 October 2012, first patient was randomized 11
April 2012.
Keywords: Sarcopenia, Frailty, Cachexia, Older people, Community-dwelling, Randomized controlled trial
* Correspondence: mikko.bjorkman@helsinki.fi
1
Geriatric Unit, Department of Internal Medicine, University of Helsinki, PO
Box 340, 00029 HUS Helsinki, Finland
Full list of author information is available at the end of the article
TRIALS
© 2013 Bjorkman et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Bjorkman et al. Trials 2013, 14:387
http://www.trialsjournal.com/content/14/1/387
Background
Age-related muscle loss (that is, sarcopenia, a syndrome
characterized by progressive and generalized loss of skeletal
muscle mass and strength [1,2]) is closely related to mal-
nutrition, physical inactivity, inflammation, and cachexia
(disease-related muscle loss) [3], which all are hallmarks
of frailty [4]. All these conditions are associated with a risk
of adverse outcomes (for example, physical disability, poor
quality of life, and increased risk of morbidity and mortality
[1-4]). According to the European consensus, sarcopenia is
defined as low fat-free mass related to squared height
in combination with low muscle strength or slow gait
speed [1]. However, there has been practical difficulties
in assessing muscle mass and, thus, diagnosing sarcopenia
[2]. Several methods are available for the measurement of
fat-free mass. These methods include magnetic resonance
imaging, computer tomography, dual x-ray absorptiometry
(DEXA), and bioimpedance analysis (BIA). The validity
of conventional BIA measurements has been questioned,
but recent evidence on direct segmental multifrequency
measurements (DSM-BIA) has shown good accuracy in
comparison with DEXA [5]. The fully portable BIA devices
also allow the assessment of disabled older persons during
home visits. Furthermore, changes in segmental intracel-
lular resistance measured by bioimpedance spectroscopy
(BIS), an extension of DSM-BIA, has been shown to be as-
sociated with changes in mobility in typical nursing home
residents prone to sarcopenia, frailty, and cachexia [6].
Even though the mechanisms of sarcopenia are complex,
adequate physical activity and nutrition are important
for the maintenance of muscle functions in older people
[1]. The broad health benefits of resistance exercise in
older people are relatively well documented [7]. However,
the lack of transportation services for the disabled patients
to the exercise facilities and the lack of human resources
often limit the large scale use of these regimens in clinical
practice. Evidence from intervention studies shows
that nutritional supplementation of older people at risk
of malnutrition increases their body weight and seems
to decrease the risk of death [8]. Furthermore, in addition
to physical exercise, the role of dietary proteins and vitamin
D has been emphasized in the prevention and treatment of
sarcopenia and frailty [9-14]. According to a 2013 sys-
tematic review, nutritional supplementation is effective
in improving muscle mass and to some extent muscle
strength as well in old age [15]. However, long-term
evidence on the effects on physical performance from
representative sarcopenic populations of older people
is scarce [13,14].
The aim of this randomized controlled trial is to investi-
gate whether and to what extent protein supplementation
and simple home-based exercises are able to maintain
physical performance in community dwelling older people
with sarcopenia. In addition, we will examine the effects
of the intervention on different aspects of muscle health,
quality of life, use of health-care services and mortality.
Methods/Design
General design
This study is a randomized controlled trial in which the
community dwelling older people with sarcopenia living
in Porvoo, Finland, are randomly allocated into three arms:
1) no supplementation, 2) protein supplementation, and
3) isocaloric placebo. In addition, all the participants will
receive instructions on simple home-based exercises,
importance of dietary protein, and the use of vitamin D
supplementation with the dose of 20 μg/d. The interven-
tion will last for 12 months. The study has been approved
by the Ethics Committee of the Helsinki University Central
Hospital. Informed consent will be obtained from each
patient or if necessary from their closest proxy before
any study procedures, which will be performed according
to good clinical practice [16].
Participants
A postal questionnaire was sent in 2012 to all people aged
75 years and older living in Porvoo, Finland (N = 3,275).
The persons at risk of sarcopenia (limitations in activities
of daily living, low physical activity, falls, exhaustion, high
age, or low body mass index (BMI)) will be contacted by
telephone, and those interested in further examinations will
be screened by hand grip strength [17] and habitual gait
speed [18]. Persons with low hand grip or slow habitual gait
speed and low skeletal muscle index (SMI) measured by
segmental calf BIS [6,19] will be recruited one by one, with
researchers approaching them or their closest proxy.
Inclusion criteria and exclusion of participants:
1. 75 years or older, living permanently at home in
Porvoo, Finland
2. able to walk indoors independently (canes and
walkers allowed)
3. able to co-operate with hand grip, walking speed,
and BIS measurements
4. lowhandgripstrength(men30.0 kg, women 20.0 kg)
or slow habitual gait speed (0.80 m/s)
5. low SMI (2 standard deviations below young adults)
measured by segmental calf BIS
6. voluntary participation, written informed consent
to participate in study by participant or her/his
closest proxy.
7. plasma creatinine <150 μmol/l
8. no terminal illness (estimated prognosis >6 months)
9. no pacemaker
10. no bilateral replacement arthroplasty of the knee
11. no severe skin lesions in BIS electrode placement
sites (dorsal foot, dorsal ankle, lateral knee, dorsal
wrist, and dorsal palm)
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Those persons fulfilling inclusion criteria are invited to
participate. All participants are asked for an informed
consent before the start of any trial procedures. In case
of the participantscognitive decline (Mini Mental State
Examination (MMSE) <19) [20] or poor capability of judg-
ment, the proxy is invited to give consent in addition to
receiving consent of the participant. The recruitment of
patients will be completed during 2013.
Study procedures
The first baseline study visit (day clinic or home visit) in-
cludes the measurement of hand grip strength, habitual
gait speed, and BMI. Patients with low hand grip or slow
gait speed will be further evaluated for their nutritional
status. These patients will be also further examined during
second baseline study visit (day clinic or home visit) includ-
ing cognition, segmental BIS, physical performance, muscle
power, and muscle endurance. In addition, the question-
naire data will be confirmed and deep frozen (20 Celsius)
blood samples collected.
Two consecutive measures of handgrip strength (kg) at
both hands are measured to the nearest 1.0 kg with subjects
sittinginanuprightpositionandthearmina90-degree
angle (JAMAR dynamometer, Saehan Corp. Masan, Korea)
[17]. The mean of the best result from both hands will
be recorded. Habitual gait speed is measured over a 4-m
course without a walking aid when possible and the best
time of two attempts will be recorded to calculate the
gait speed = distance (m)/time (s) [18]. SMI will be mea-
sured with a single channel, tetra polar BIS device (SFB7,
ImpediMed Ltd., Eight Miles Plains, Queensland, Australia)
that scans 256 frequencies between 4 kHz and 1000 kHz.
Raw data are analyzed with the supporting software
(version 5.3.1.1, SFB7, ImpediMed Ltd., Eight Miles Plains,
Queensland, Australia) supplied by the manufacture to
obtain values for the calculation of SMI (SMI = electro
distance
2
/calf intracellular resistance [6,19]). In addition
to the participants, SMI will be also measured in young
healthy adults to provide the cut-points for low SMI
values. Physical performance will be assessed by the
short physical performance battery (SPPB) [21], which
consists of three components: balance, gait speed, and
chair rise ability. Scores of 1 to 4 are based on categories of
performanceinthebalancetests,onthetimenecessaryto
complete the walk, and on the time needed to perform the
chair-rise test. A summary performance score of 0 to 12
will be calculated by summing the scores of the tests. These
three components (balance, gait speed, and chair rise) will
also used to calculate continuous summary physical per-
formance scores (CSPPS = 0 to 100) [22,23] Muscle power
will be measured by the Takai et al. chair stand test [24]
andmuscleendurancebythetwo-minutesteptest[25].
Nutritional status will be assessed by the Mini Nutritional
Assessment (MNA) [26], the dietary quality questionnaire
[27] and the three-day dietary record [28]. Cognition will
be assessed by the Clinical Dementia Rating Scale (CDR)
[28], the Mini Mental State Examination (MMSE) [20],
verbal fluency [29,30], and the clock drawing test [31].
Health-related quality-of-life (HrQOL) will be assessed
by SF-36 [32] and 15D [33] measures. Participants will
be examined by the research group three times during
the year: at baseline, and at 6, and 12 months. The flow
chart of the study is presented in Figure 1, and study
assessment procedures are described in Table 1. Hospitali-
zations, use of other health and social services and death
dates will be retrieved from the central registers until two
years from baseline measurements.
After receiving an informed consent the patients fulfill-
ing the inclusion criteria are randomized by computer-
generated random numbers (Microsoft Excel 2010,
Redmond, WA, USA) into three arms: 1) no supplementa-
tion, 2) protein supplementation, and 3) isocaloric placebo.
First a list including 100 sets of the numbers 1, 2, and 3 in
random order is computer-generated to indicate each treat-
ment group, which results in a list of 300 open slots with
100 slots for each treatment group. At the time of each
patient recruitment a random number between 1 and 3 is
computer-generated to indicate the open slot in the original
list (1 = first open slot, 2 = second open slot, 3 = third open
slot) to rule out the selection bias by the research group.
The group treatment is randomized off-site and the content
of the supplement (protein supplement versus isocaloric
placebo) is kept sealed outside the research group until data
collection and analysis of endpoints are complete. Further-
more, all the supplements are packed in blank 250-ml tetras
and flavored with strawberry.
Intervention
All participants receive instructions on simple home-based
exercises, dietary protein and vitamin D supplementation.
The home-based exercises are based on the national
recommendations (www.voimaavanhuuteen.fi) to support
walking and the role of chair, stand and step exercises are
emphasized with written instructions. The participants are
instructed to exercise 10 to 30 minutes twice a day. Partici-
pantsarealsogivenwritteninformationondietaryprotein
and nutrition in old age based on national recommenda-
tions (www.ravitsemuskotona.fi) as well as encouraged to
use vitamin D supplementation with a dose of 20 μg/d.
The three arms of the intervention include: 1) no supple-
mentation, 2) protein supplementation, and 3) isocaloric
placebo. In groups 2 and 3 the participants are instructed
to take twice daily a 250 ml beverage as a snack between
meals immediately after an exercise session, whereas in
group 1 the participants are instructed to take regular
protein rich foods in similar fashion. In the protein
supplementation group the participants will receive a
maximum of 40 grams (20 grams x 2) of extra milk derived
Bjorkman et al. Trials 2013, 14:387 Page 3 of 7
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proteins daily compared with 7.5 grams (3.75 grams x 2) in
the isocaloric placebo group. After each exercise session
and ingestion of supplement the participants will record
the level of exercise and amount of ingested supplement
in a dairy. The compliance to the home-based exercises,
nutritional supplements and vitamin D supplement is
assessed also by interviewing the patients during each study
visit. The intervention will last for 12 months. The nutri-
tional contents of the protein supplement and isocaloric
placebo are shown in Table 2. All supplements are manu-
factured and provided by Valio Ltd, Helsinki, Finland.
Outcome measurements
The examinations are performed at 0, 6 and 12 months.
In addition to this, follow-up data are also collected from
registries at 24 months.
Primary outcome measures are:
1. The 6- and 12-month changes in physical performance
according to mean SPPB [21] and CSPPS [22,23]scores
2. Changes in muscle functions according to hand grip
strength [17], gait speed [18], balance [19], chair
stand test [24], two-minute step test [25]
Secondary outcome measures are:
1. Compliance to supplementation and home based
exercises
2. Patient reported benefits and adverse effects
3. Changes in nutrition according to MNA [26],
diet quality questionnaire [27], and dietary
records [28]
4. Changes in body composition according to BMI and
segmental BIS measurements [6,19]
5. Changes in cognition according to MMSE [20],
verbal fluency [29,30] and clock drawing test [31],
and CDR sum of boxes [35]
6. Changes in HrQOL measures according to SF-36
[32] and 15D [33]
7. Number of falls
8. Serum and plasma markers of inflammation,
anabolism, glycemic control and renal function
9. Use of health care (number of hospitalization/
follow-up time) and social services (number of
institutionalization/follow-up time) during a
24 month follow-up
10. Mortality during a 24 month follow-up
Figure 1 Flow chart [34].
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Statistical analyses
Required sample size calculation (PS: Power and Sample
Size Calculations version 3.0.43, Nashville, TN, USA) is
based upon the change in SPPB. A change of 0.5 in SPPB
score has been defined as minimally important and change
of 1.0 as substantially important. With a standard deviation
(SD) of 2.0 for SPPB, a type I error rate of 5%, a power of
80%, and a drop-out rate of 25%, we will need approxi-
mately 80 patients in each group to detect a substantial
change in SPPB, when the effects of protein supplementa-
tion are compared against no additional supplementation
or isocaloric placebo with a Students t-test independently.
Multiple comparison will be performed by Dunnettstest
[36].Thefinalsamplesizemaydifferslightlyfromthis
figure, because we will recruit participants from the
entire 75 years and older population living in Porvoo,
Finland, and the aim is to include as many as possible
from those answering the postal questionnaire.
The statistical analyses will be performed by PASW
statistics 18.0.3 (SPSS Inc. Chicago, IL, USA). In the
baseline findings, for the continuous variables, descriptive
values will be expressed by means with SD and medians
with range. For the variables with a normal (Gaussian)
distribution, statistical comparisons between the groups
will be made by using an analysis of variance test. If the
variables have a non-normal distribution or ordinal level,
statistical comparison between groups will be performed
with an independent samples Kruskal-Wallis test. Mea-
sures with a discrete distribution will be expressed as
percentages(%)andanalyzedbyX
2
or Fishers exact test
when appropriate.
The results will be analyzed according to intention
to treat. For the most important outcome parameters
estimation of confidence interval (95%) will be used in
addition to testing.
Discussion
This rigorous randomized controlled trial will test whether
and to what extent protein supplementation is able to
maintain physical performance in community dwelling
older people with sarcopenia. In addition to protein supple-
mentation, the systematic use of simple and evidence-based
Table 1 Study assessment procedures and timetable
Assessment Postal questionnaire Baseline 6 months 12 months 24 months
Demographics, diagnoses, drugs, supplements, exhaustion, walking aid X
Inclusion criteria, informed consent X X
Physical activity X X X X
15D
1
and SF-36
2
QOL measures X X X X
MNA
3
, dietary quality questionnaire, dietary record X X X
BMI
4
, SMI
5
XX X
Hand grip strength (Bohannan 2008) X X X
SPPB
6
XX X
Takai chair stand test (Takai et al. 2009) X X X
Two-minute step test (Rikli and Jones 1999) X X X
CDR
7
XX X
MMSE
8
XX X
Verbal fluency (Morris et al. 1989), clock drawing test
(Sunderland et al. 1989)
XX X
Deep frozen blood samples X X X
Falls XX X
Hospitalization, use of health and social services, mortality X X
1
15D = health related quality of life scale (Sintonen et al. 1990);
2
SF-36 = health related quality of life scale (Hays et al. 1993);
3
MNA = mini nutritional assessment
(Guigoz et al. 2002);
4
BMI = body mas s index;
5
SMI = skeletal muscle index (Björkman et al . 2012);
6
SPPB = short physical performance battery (Guralnik et al. 1994);
7
CDR = Clinical deme ntia Rating Scale (Hughes et al. 1982);
8
MMSE = Minimental State Examination (Folstein et al . 1972). Questionnaires will be in Finnish or
Swedish according to participants first language.
Table 2 Nutritional content of the supplements
Protein
supplement 100 g
Isocaloric
placebo 100 g
Proteins (of which whey), g 8.3 (4.0) 1.0 (0.2)
Carbohydrates (of which lactose), g 7.0 (0.0) 14.0 (0.0)
Fat, % 1.0 1.0
Energy, kcal 70.0 70.0
Vitamin D, ug 1.0 0.2
All supplements are manufactured and provided by Valio Ltd, Helsinki, Finland.
Bjorkman et al. Trials 2013, 14:387 Page 5 of 7
http://www.trialsjournal.com/content/14/1/387
methods to maintain muscle health in old age including
home-based exercise, vitamin D supplementation and
protein rich foods are promoted among all participants.
The intervention is pragmatic in nature, and is performed
in close collaboration with the municipal health care
services. Thus, if the intervention proves to be effective,
it can be implemented easily.
The strength of this study is its pragmatic nature [37].
Thus, the findings should be applicable in real life. The
target population is frail and vulnerable and, according
to our previous studies, is at risk of adverse outcomes
such as physical disability and poor quality of life and
death. Thus, ceiling effect is not easily reached in the
primary endpoint. Furthermore, the limited exclusion
criteria and portable nature of all study procedures allow
the inclusion those disabled older people that are other-
wise often not included in clinical trials.
However, there are also potential limitations in this
study. First, the population is old and frail with many
comorbidities, and, thus, vulnerable to competing causes of
complications and deaths. This may decrease the power
of the study. The second challenge relates to a sufficient
difference to be attained between the groups with our
intervention because nutritional supplementation may
diminish the intake of regular food. Furthermore, the
long-term adherence of patients to single taste supple-
ments and unsupervised home-based exercises is also a
challenge to this study.
To our knowledge, this is the first large scale randomized
controlled trial among community dwelling older people
with sarcopenia that focuses on the effects of protein
supplementation on physical performance and several
aspects of muscle health, nutritional status, QoL, cog-
nition and hospitalizations.
Trial status
Recruiting was underway at time of manuscript submission.
Abbreviations
BIA: Bioimpedance analysis; BIS: Bioimpedance spectroscopy; BMI: Body mass
index; CDR: Clinical dementia rating scale; DEXA: Dual x-ray absorptiometry;
DSM-BIA: Direct segmental multifrequencymeasurements;HrQOL: Health-related
quality-of-life; MMSE: Minimental state examination; MNA: Mini nutritional
assessment; QOL: Quality of life; SD: Standard deviation; SMI: Skeletal muscle index;
SPPB: Short physical performance battery.
Competing interests
Dr Mikko Björkman reports professional cooperation including lecturing fees
from Valio Ltd. Dr Pitkälä reports having professional cooperation including
lecturing fees from pharmaceutical and other health care companies
(including Janssen-Cilag, Lundbeck, MSD Finland, Orion, Pfizer, Novartis, Nestle),
and having participated in clinical trials funded by pharmaceutical companies.
Merja Suominen, Dr Harriet Finne-Soveri, and Dr Reijo Tilvis have no
competing interests.
Authorscontributions
MPB, MHS, KHP, F-SUH, and RST participated in study conception and design;
MPB, MHS, KHP, F-SUH, and RST participated in acquisition of data, or analysis
and interpretation of data; and MPB, MHS, KHP, F-SUH, and RST participated in
drafting or critically revising the manuscript for important intellectual
content. MPB had full access to all of the data in the study and takes
responsibility for the integrity of the data and the accuracy of the data
analysis. MPB is the guarantor. Valio Ltd. and other funders of this study
will have no author contributions. All authors read and approved the final
manuscript.
Acknowledgements
This study is funded by University of Helsinki, by a special governmental
subsidy for health sciences research and training to Helsinki University
Central Hospital, by Yrjö Jahnsson Foundation and by Konung Gustaf
V:s och Drottning Victorias Frimurarestiftelse. The study is conducted in
collaboration with the municipal health care and social services of
Porvoo, Finland. All supplements are manufactured and provided by Valio
Ltd, Helsinki, Finland.
Author details
1
Geriatric Unit, Department of Internal Medicine, University of Helsinki, PO
Box 340, 00029 HUS Helsinki, Finland.
2
Society for Memory Disorders
Expertise in Finland, Fredriksberginkatu 2, 00240 Helsinki, Finland.
3
Unit of
General Practice, Helsinki University Central Hospital, Department of General
Practice, University of Helsinki, PO Box 20, 00014 Helsinki, Finland.
4
National
Institute for Health and Welfare, P.O. Box 30, FI-00271 Helsinki, Finland.
Received: 3 January 2013 Accepted: 28 October 2013
Published: 14 November 2013
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doi:10.1186/1745-6215-14-387
Cite this article as: Bjorkman et al.:Porvoo sarcopenia and nutrition trial:
effects of protein supplementation on functional performance in home-
dwelling sarcopenic older people - study protocol for a randomized
controlled trial. Trials 2013 14:387.
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... Lastly, healthcare costs related to intervention effects should be assessed in an economic evaluation, as this is important to support sustainable implementation of the intervention and to embed the intervention in the policy of care organisations or local governments. Although some studies on different physical activity and/or diet interventions in older adults include all three evaluation components [12,13], most studies report only effect evaluations [14][15][16]. There is thus a lack of information on the other evaluation components for the implementation of a resistance exercise and diet intervention to counteract sarcopenia in practice. ...
... The intervention comprises resistance exercise training with a focus on the leg muscles and a diet intervention focused on increasing protein intake. For the intervention group, this includes a 12-week intensive support intervention period (weeks 1-12) followed by a 12-week moderate support intervention period (weeks [13][14][15][16][17][18][19][20][21][22][23][24]. The control group receives no intervention (weeks 1-24) to allow comparison with the intervention group in this period, followed by the delayed moderate support intervention (weeks [25][26][27][28][29][30][31][32][33][34][35][36]. ...
Article
Full-text available
Background: Exercise and nutrition are important for older adults to maintain or to regain their muscle mass, function, strength, and ultimately quality of life. The effectiveness of combined resistance exercise and diet interventions is commonly evaluated in controlled clinical studies, but evidence from real-life settings is lacking. This article describes the effectiveness, process, and economic evaluation design of a combined nutrition and exercise intervention for community-dwelling older adults in a Dutch real-life setting. Methods: The ProMuscle in Practice study is a randomised controlled multicentre intervention study, conducted in five municipalities in the Netherlands. Two hundred community-dwelling older adults (≥65 years) who are frail or pre-frail based on Fried frailty criteria or who experience strength loss are randomised over an intervention and control group by municipality. In the first 12-week intensive support intervention, participants in the intervention group perform resistance exercise training guided by a physiotherapist twice a week and increase protein intake by consuming protein-rich products under the supervision of a dietitian. Afterwards, they continue with a 12-week moderate support intervention. The control group receives only regular care during the two 12-week periods. Effect outcomes are measured at all locations at baseline, 12 weeks, 24 weeks, 36 weeks and only at three locations at 52 weeks. The primary outcome is physical functioning (Short Physical Performance Battery). Secondary outcomes include leg muscle strength, lean body mass, activities of daily living, social participation, food intake, and quality of life. Qualitative and quantitative implementation process data are collected during the intervention. Healthcare use and intervention costs are registered for the economic evaluation. Discussion: Evaluating the effects, implementation, and costs of this combined intervention provides valuable insight into the feasibility of this intervention for community-dwelling older adults and into the intervention's ability to improve or to maintain physical functioning and quality of life. Trial registration: Netherlands Trial Register ( NTR6038 ) since 30 August 2016.
... The detailed methods of this 12-month double blind RCT have been published elsewhere. 12 Briefly, a postal screening of the older population (>74 years of age, n ¼ 3275) and further clinical examination of 773 community-dwelling older people living in the Porvoo city were performed (Supplementary Figure 1). The participants had to be able to walk indoors independently, although canes and walkers were allowed. ...
... Sample size calculation has been presented in our previous article. 12 Statistical comparison between the groups at baseline was performed using analysis of variance or the c 2 when appropriate. All participants assessed at baseline, 6-month, and 12-month examinations were included in the data analyses of changes in SPPB and CSPPS (modified intention to treat). ...
Article
Objectives: To test the long-term effects of whey-enriched protein supplementation on muscle and physical performance. Design: A 12-month randomized controlled double blind trial with a 43-month of post-trial follow-up. Setting: Porvoo, Finland. Participants: A total of 218 older (>74 years of age) community-dwelling people with sarcopenia. Intervention: (1) Control with no supplementation; (2) isocaloric placebo; and (3) 20 g × 2 whey-enriched protein supplementation. All participants were given instructions on home-based exercise, dietary protein, and vitamin D supplementation of 20 μg/d. Measurements: Physical performance was assessed by short physical performance battery and continuous summary physical performance scores. Hand grip strength and calf intracellular resistance based skeletal muscle index were measured by bioimpedance spectroscopy. The measurements were performed at 0, 6, and 12 months. The post-trial follow-up was performed by a postal questionnaire and national census record data. Results: The participants were older (75-96 years of age) and mostly women (68%). The test supplements had no significant effects on physical performance; the 12-month changes for short physical performance battery were -0.55, -.05, and 0.03 points in control, isocaloric, and protein groups (P = .17), respectively. The changes in continuous summary physical performance scores were similar between the intervention groups (P = .76). The hand grip strength decreased significantly in all intervention groups, and the 12-month changes in calf intracellular resistance-based skeletal muscle index were minor and there were no differences between the intervention groups. One-half of the patients (56%) in both supplement groups reported mild gastrointestinal adverse effects. Differences were found neither in the all-cause mortality nor physical functioning in the post-trial follow-up. Conclusions: The whey-enriched protein supplementation in combination with low intensity home-based physical exercise did not attenuate the deterioration of muscle and physical performance in community-dwelling older people with sarcopenia.
... Sarcopenia has several annihilating effects on the patients, these mainly include, higher risks of imbalance and injuries, poor quality of life and elevated rates of frailty and morbidity. It is found to be caused extensively among various individuals mainly due to physical inactivity, malnutrition and cachexia [6]. With the progression of age, a rapid decline in anabolic hormone levels such as growth hormone, testosterone, thyroid hormone, and insulin-like growth factor has been found to have excessive deteriorative effects on the muscle mass and strength. ...
Article
Sarcopenia, a commonly prevalent geriatric condition mainly characterized by progressive loss of the skeletal muscle mass that result in noticeable reduced muscle strength and quality. Most of the geriatric population of above 60 years of age are overweight leading to the accumulation of fat in the muscles resulting in abated muscle function. The increased loss of muscle mass is associated with high rates of disability, poor motility, frailty and mortality. The excessive degeneration of muscles is now also being observed in middle aged people. Therefore, geriatrics has recently started shifting towards the identification of early stages of the disability in order to expand the life span of the patient and reduce physical dependence. Recent findings have indicated that patients with increased physical activity are also affected by sarcopenia, therefore indicating the role of nutritional supplements to enhance muscle health which in turn helps to counteract sarcopenia. Various interventions with physical trainings haven’t provided substantial improvements of this disorder thereby highlighting the crucial role of nutritional supplementation in enhancing muscle mass and strength. Nutritional supplementation has not only shown to enhance the positive effects of physical interventions but also have a profound impact on the gut microbiome that has come forward as a key regulator of muscle mass and function. This brief review throws light upon the efficiency of nutrients and nutraceutical supplementation by highlighting their ancillary effects in physical interventions as well as improving the gut microbiome status in sarcopenic adults thereby giving rise to a multimodal intervention for the treatment of sarcopenia.
... The data were derived from the Porvoo Sarcopenia and Nutrition Trial (ACTRN12612001253897) (32). Briefly, we approached the 75+ population living in Porvoo, Finland (N=3275) via a postal questionnaire (response rate 60.5%), and the research group further examined the individuals at risk of sarcopenia (limitations in activities of daily living, sedentary lifestyle, falls, exhaustion, old age, low BMI) (N= 428). ...
Article
Objectives Sarcopenia is associated with poor health outcomes. We examined the relative roles of muscle mass, strength, physical performance and obesity as health predictors among older sarcopenic people. Design and participants This prospective study examined community-dwelling people aged 75+ (N=262). Setting Porvoo Sarcopenia and Nutrition Trial. Measurements We collected demographic data and medical history by postal questionnaire including RAND-36 at baseline and at four years and measured BMI, Short Physical Performace Battery (SPPB), hand-grip strength, cognition and two surrogate measures of muscle mass; the Single Frequency Skeletal Muscle Index (SF-SMI) and the Calf Intracellular Resistance Skeletal Muscle Index (CRi-SMI). Results Adjusted for age and gender, independent outdoors mobility was predicted positively by baseline physical functioning scores in RAND-36 (p<0.001), the SPPB (p<0.001), the two-minute step test (p<0.001), and grip strength (p=0.023), as well as CRi-SMI (p<0.001). However, the prediction was negative in BMI (p<0.001) and the Charlson co-morbidity Index (p= 0.004). Similar associations were found when the physical component RAND-36 was used as an outcome measure. The use of home care was predicted by high co-morbidity (p=0.057) and low scores in RAND-36 (p<0.001), SPPB (p<0.001) and the two-minute step test (p<0.001), and low CRi-SMI (p< 0.001). CRi-SF was a more consistent predictor than SF-SMI, which was partly masked by BMI. Controlled for age, gender and comorbidity, a 10% difference in CRi-SMI was associated with a 4% higher probability (p=0.019) of independently living at home, whereas the respective figures for SF-SMI and BMI were −18% (p=0.098) and −14% (p=0.088). Conclusions In contrast to SF-SMI, high CRi-SMI appeared to indicate good prognosis and less need of care, independently of BMI.
... This cross-sectional study is based on the baseline screening data of the Porvoo sarcopenia and Nutrition trial (ACTRN12612001253897). The trial procedures have been published elsewhere [13]. We approached the population aged 75 + living in Porvoo, Finland (N = 3275) by a postal questionnaire (response rate 60.5%) and the research group further examined the individuals at risk of sarcopenia (limitations in daily living activities, sedentary lifestyle, falls, exhaustion, old age, low body mass index (BMI)). ...
Article
Full-text available
Background Bioimpedance skeletal muscle indices (SMI) are used as a surrogate for skeletal muscle mass, but their associations with physical functioning and obesity need further evaluation. Aims To compare the associations of body mass index (BMI), bioimpedance spectroscopy-based calf intracellular resistance (Cri-SMI), and single-frequency bioimpedance analysis (SF-SMI) indices with physical performance and the functioning of community-dwelling older people at risk of or already suffering from sarcopenia. Methods Pre-intervention measurements of the screened subjects and the participants of the Porvoo sarcopenia trial (N = 428) were taken. Cri-SMI, whole-body SF-SMI, and BMI were related to hand-grip strength, walking speed, short physical performance battery (SPPB), and the physical component of the RAND-36. Results Among the older people (aged 75–96), Cri-SMI correlated inversely with age (men r = - 0.113, p < 0.001; women r = - 0.287, p < 0.001), but positively with SPPB (r = 0.241, p < 0.001) and the physical component of the RAND-36 (r = 0.114, p = 0.024), whereas BMI was inversely associated with SPPB (r = - 0.133, p < 0.001) and RAND-36 (r = - 0.286, p < 0.001). After controlling for age, gender, and comorbidity, one unit of Cri-SMI (cm²/Ω) was associated with a 3.3-fold probability of good physical performance (SPPB ≥ 9 points, OR = 3.28, p < 0.001) and one unit of BMI (kg/m²) decreased the respective probability 4% (OR= 0.96, p = 0.065). Physical inactivity partly explained the negative association of BMI. When Cri-SMI and BMI were controlled for, a 1% difference in Cri-SMI was associated with a 0.7% (p < 0.001) higher probability of good performance, the respective figure being - 2.2% (p = 0.004) for BMI. The associations of SF-SMI with physical functioning indices were insignificant. Conclusions Independent of each other, Cri-SMI was positively and BMI was inversely associated with the physical performance and functioning of community-dwelling older people who were at risk of or already suffering from sarcopenia. We found no association between SF-SMI and physical functioning.
... Διάφορες επιδημιολογικές μελέτες (Baumgartner, et al., 1998;Sun et al., Neto et al., 2015) (Bjorkman, et al., 2013) μέχρι και πιο έντονες ασκήσεις σε κλειστά τμήματα με την καθοδήγηση ειδικού γυμναστή (Suzana, 2013). περιεχόμενο των αμινοξέων, πρωτεΐνη πηγή κ.α.). ...
Preprint
Η Σαρκοπενία αποτελεί ένα γηριατρικό γίγαντα και συγκαταλέγεται μεταξύ των γηριατρικών συνδρόμων με την μεγαλύτερη συχνότητα εμφάνισης μαζί με την ακινησία και την αστάθεια. Παρουσιάζεται στο 5% με 13% των ατόμων με ηλικία πάνω από 60 ετών και το 50% των ατόμων πάνω από 80 ετών. Η άμεση επίπτωση της παρουσίας αυτού του συνδρόμου είναι η δυσανάλογη απώλεια μάζας σε σχέση με την ηλικία και έχει άμεσες επιπτώσεις στην κινητικότητα του ατόμου όπως και έμμεσες επιπλοκές που έχουν σχέση με κατάγματα από πτώση. Οι επιπτώσεις τόσο στο ίδιο το άτομο όσο και στο άμεσο οικογενειακό του περιβάλλον είναι σημαντικές αφού επηρεάζει τον όλο τρόπο ζωής και συνηθειών του. Παράλληλα το οικονομικό βάρος του συστήματος υγείας είναι σημαντικό έχοντας αγγίξει το 1,5% του εθνικού προϋπολογισμού για την υγεία στις Η.Π.Α. Με κύριο γνώμονα την γνωστοποίηση της σοβαρότητας και της αυξητικής τάσης εκδήλωσης της σαρκοπενίας, πραγματοποιήθηκε έρευνα με σκοπό την εκτίμηση του βαθμού που έχει η χορήγηση πρωτεΐνης στην αύξηση της μυϊκής μάζας των πασχόντων με σαρκοπενία και την επίδραση αυτής της χορήγησης στον βαθμό βελτίωσης στην ποιότητα ζωής των ασθενών, πραγματοποιήθηκε συστηματική βιβλιογραφική ανασκόπηση των μελετών των τελευταίων 5 ετών μεταξύ σαρκοπενικών ατόμων για την εξέταση της προόδου και τυχόν μεταβολών στα αποτελέσματα προηγούμενων ερευνών. Τα αποτελέσματα της έρευνας έδειξαν ότι οι εξεταζόμενες έρευνες έδειξαν βελτίωση της φυσικής κατάσταση των ατόμων που συμμετείχαν στην έρευνα αλλά όχι αύξηση της μυϊκής μάζας ούτε της ποιότητας ζωής τους. Η συμβολή της χορήγησης πρωτεΐνης δεν μπόρεσε να αποδείξει κάποια βελτίωση στην αντιμετώπιση της σαρκοπενίας ενώ επιπλέον διαπιστώθηκε η έλλειψη κοινών ορισμών, μετρήσεων και πρωτοκόλλων έρευνας για την σαρκοπενία.
... We derived our data from the Porvoo Sarcopenia and Nutrition Trial (ACTRN12612001253897) (Bjorkman et al., 2013). We approached the population aged 75+ living in Porvoo, Finland (N = 3275) by a postal questionnaire (response rate 60.5%) and the research group further examined the individuals at risk of sarcopenia (N = 428). ...
Article
Objectives: To assess the prognostic significance of various characteristics and measurements of sarcopenia and physical functioning on all-cause mortality among home-dwelling older people with or at-risk of sarcopenia. Design: Cross-sectional and longitudinal analyses. Setting: Porvoo sarcopenia trial in open care. Participants: Community-dwelling people aged 75 and older (N = 428, of which 182 were re-examined at one year) with four years of follow-up. Measurements: Body mass index (BMI), physical functioning (physical component of the RAND-36) and physical performance tests (Short Physical Performance Battery (SPPB)), hand grip strength, walking speed, Charlson Comorbity Index, bioimpedance-based surrogates for muscle mass: Single Frequency Skeletal Muscle Index (SF-SMI), and Calf Intracellular Resistance Skeletal Muscle Index (CRi-SMI). Date of death was retrieved from central registers. Survival analyses were performed using Life-Table analyses and Cox models. Results: Most test variables (except BMI) were associated with four-year mortality in a dose-dependent fashion. After controlling for age, gender and co-morbidity, physical performance and functioning (both SPPB and RAND-36), muscle strength (hand grip strength) and CRi-SMI appeared to be independent mortality risk indicators (p < 0.001) whereas SF-SMI was not. When CRi-SMI values were grouped by gender-specific cut-off points, the probability of surviving for four years decreased by 66% among the older people with low CRi-SMI (HR = 0.34, 95%CI 0.15-0.78, p = 0.011). When low CRi-SMI was further controlled for SPPB, the prognostic significance remained significant (HR = 0.55, 95%CI 0.33-0.92, p = 0.021). After controlling for age, gender, comorbidity, and CRi-SMI, the physical component of the RAND-36 (p = 0.007), SPPB (p < 0,001) and hand grip strength (p = 0.009) remained significant mortality predictors. Twelve-month changes were similarly associated with all-cause mortality during the follow-up period. Conclusion: CRi-SMI, muscle strength, physical performance and physical functioning are each strong independent predictors of all-cause mortality among home-dwelling older people. Compared to these indicators, BMI seemed to be clearly inferior. Of two bioimpedance-based muscle indices, CRi SMI was better predictor of mortality than SF-SMI. In this regard, muscle mass, muscle strength and physical performance are all suitable targets for the prevention of sarcopenia-related over-mortality.
... Evidence exists that muscle strength per body mass index (BMI) would be an appropriate relative strength index in clinical settings (1,(10)(11)(12). However, research in community settings and the association of this index with protein intake and diet quality has not been fully investigated (13)(14)(15)(16). ...
Article
Full-text available
Objective: To determine the association of handgrip strength (HS) with protein intake, diet quality, and nutritional and cardiovascular biomarkers in African American and White adults. Design: Cross-sectional wave 3 (2009-2013) of the cohort Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study. Participants: Socioeconomically diverse urban population of 2,468 persons aged 33 to 71 years. Measurements: Socio-demographic correlates, dietary intakes and biomarkers, HS, physical performance measures were collected. HS was measured using a dynamometer with the dominant hand. Functional measures included chair, tandem, and single leg stands. Two 24-hour recalls were collected using the US Department of Agriculture Automated Multiple Pass Method. The total protein intake and diet quality, evaluated by adherence to the DASH eating plan and Healthy Eating Index-2010, were calculated. Biomarkers included nutritional anemia, and serum levels of albumin, cholesterol, magnesium, and glucose. Results: The mean ±SE age of the sample was 52.3±0.2 years. Approximately 61% were African American and 57% were women. The mean ±SE HS of women was 29.1±0.2kg and for men was 45.9±0.4 kg. Protein, gm, per kg body weight for the women was 0.94±0.02 compared to 1.16 ±0.02 for men. After adjusting for socio-demographic factors, hypertension, and diabetes, HS/BMI ratio was significantly associated with protein intake per kg body weight (p<0.001) and diet quality, assessed by either the DASH adherence (p=0.009) or Health Eating Index-2010 (p=0.031) scores. For both men and women, participants in the upper tertile of HS maintained a single leg and tandem stances longer and completed 5 and 10 chair stands in shorter time compared to individuals in the lower HS tertile. Of the nutritional status indicators, the percent of men in the upper HS tertile with low serum magnesium and albumin, was significantly lower than those in the lower HS tertile [magnesium,7.4% vs 16.1%; albumin, 0.4% vs 4.5%]. The only difference observed for women was a lower percent of diabetes (14.4% for the upper HS tertile compared to 20.5% for the lower HS tertile. Conclusions: The findings confirm the role of protein and a healthful diet in the maintenance of muscle strength. In this community sample, HS was significantly associated with other physical performance measures but did not appear to be strongly associated with indicators of nutritional risk. These findings support the use of HS as a proxy for functional status and indicate the need for research to explore its role as a predictor of nutritional risk.
Article
Background: Disease-related malnutrition has been reported in 10% to 55% of people in hospital and the community and is associated with significant health and social-care costs. Dietary advice (DA) encouraging consumption of energy- and nutrient-rich foods rather than oral nutritional supplements (ONS) may be an initial treatment. Objectives: To examine evidence that DA with/without ONS in adults with disease-related malnutrition improves survival, weight, anthropometry and quality of life (QoL). Search methods: We identified relevant publications from comprehensive electronic database searches and handsearching. Last search: 01 March 2021. Selection criteria: Randomised controlled trials (RCTs) of DA with/without ONS in adults with disease-related malnutrition in any healthcare setting compared with no advice, ONS or DA alone. Data collection and analysis: Two authors independently assessed study eligibility, risk of bias, extracted data and graded evidence. Main results: We included 94, mostly parallel, RCTs (102 comparisons; 10,284 adults) across many conditions possibly explaining the high heterogeneity. Participants were mostly older people in hospital, residential care and the community, with limited reporting on their sex. Studies lasted from one month to 6.5 years. DA versus no advice - 24 RCTs (3523 participants) Most outcomes had low-certainty evidence. There may be little or no effect on mortality after three months, RR 0.87 (95% confidence interval (CI) 0.26 to 2.96), or at later time points. We had no three-month data, but advice may make little or no difference to hospitalisations, or days in hospital after four to six months and up to 12 months. A similar effect was seen for complications at up to three months, MD 0.00 (95% CI -0.32 to 0.32) and between four and six months. Advice may improve weight after three months, MD 0.97 kg (95% CI 0.06 to 1.87) continuing at four to six months and up to 12 months; and may result in a greater gain in fat-free mass (FFM) after 12 months, but not earlier. It may also improve global QoL at up to three months, MD 3.30 (95% CI 1.47 to 5.13), but not later. DA versus ONS - 12 RCTs (852 participants) All outcomes had low-certainty evidence. There may be little or no effect on mortality after three months, RR 0.66 (95% CI 0.34 to 1.26), or at later time points. Either intervention may make little or no difference to hospitalisations at three months, RR 0.36 (95% CI 0.04 to 3.24), but ONS may reduce hospitalisations up to six months. There was little or no difference between groups in weight change at three months, MD -0.14 kg (95% CI -2.01 to 1.74), or between four to six months. Advice (one study) may lead to better global QoL scores but only after 12 months. No study reported days in hospital, complications or FFM. DA versus DA plus ONS - 22 RCTs (1286 participants) Most outcomes had low-certainty evidence. There may be little or no effect on mortality after three months, RR 0.92 (95% CI 0.47 to 1.80) or at later time points. At three months advice may lead to fewer hospitalisations, RR 1.70 (95% CI 1.04 to 2.77), but not at up to six months. There may be little or no effect on length of hospital stay at up to three months, MD -1.07 (95% CI -4.10 to 1.97). At three months DA plus ONS may lead to fewer complications, RR 0.75 (95% CI o.56 to 0.99); greater weight gain, MD 1.15 kg (95% CI 0.42 to 1.87); and better global QoL scores, MD 0.33 (95% CI 0.09 to 0.57), but this was not seen at other time points. There was no effect on FFM at three months. DA plus ONS if required versus no advice or ONS - 31 RCTs (3308 participants) Evidence was moderate- to low-certainty. There may be little or no effect on mortality at three months, RR 0.82 (95% CI 0.58 to 1.16) or at later time points. Similarly, little or no effect on hospitalisations at three months, RR 0.83 (95% CI 0.59 to 1.15), at four to six months and up to 12 months; on days in hospital at three months, MD -0.12 (95% CI -2.48 to 2.25) or for complications at any time point. At three months, advice plus ONS probably improve weight, MD 1.25 kg (95% CI 0.73 to 1.76) and may improve FFM, 0.82 (95% CI 0.35 to 1.29), but these effects were not seen later. There may be little or no effect of either intervention on global QoL scores at three months, but advice plus ONS may improve scores at up to 12 months. DA plus ONS versus no advice or ONS - 13 RCTs (1315 participants) Evidence was low- to very low-certainty. There may be little or no effect on mortality after three months, RR 0.91 (95% CI 0.55 to 1.52) or at later time points. No study reported hospitalisations and there may be little or no effect on days in hospital after three months, MD -1.81 (95% CI -3.65 to 0.04) or six months. Advice plus ONS may lead to fewer complications up to three months, MD 0.42 (95% CI 0.20 to 0.89) (one study). Interventions may make little or no difference to weight at three months, MD 1.08 kg (95% CI -0.17 to 2.33); however, advice plus ONS may improve weight at four to six months and up to 12 months. Interventions may make little or no difference in FFM or global QoL scores at any time point. Authors' conclusions: We found no evidence of an effect of any intervention on mortality. There may be weight gain with DA and with DA plus ONS in the short term, but the benefits of DA when compared with ONS are uncertain. The size and direction of effect and the length of intervention and follow-up required for benefits to emerge were inconsistent for all other outcomes. There were too few data for many outcomes to allow meaningful conclusions. Studies focusing on both patient-centred and healthcare outcomes are needed to address the questions in this review.
Article
Background and Aim We aimed to examine the validity of the Japanese version of the SARC‐F questionnaire (SARC‐F‐J) that employs the diagnostic criteria for sarcopenia established by the Japan Society of Hepatology in patients with chronic liver disease. Methods Subjects were outpatients at the Department of Hepatology at the Japanese Red Cross Ise Hospital, Japan. Evaluations were performed using the following self‐administered questionnaires: SARC‐F‐J, Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG‐IC), the Japanese version of the Falls efficacy scale (FES), and Kaigo–Yobo checklist (CL). Based on the diagnostic criteria of the Japan Society of Hepatology, we diagnosed sarcopenia from the skeletal muscle index calculated using the iliopsoas muscle area at the third lumbar vertebra on computed tomography and from grip strength. To evaluate construct validity, we calculated the sensitivity, specificity, and positive and negative predictive values of SARC‐F‐J that used the diagnostic criteria of the Japan Society of Hepatology as reference. Furthermore, to evaluate convergent validity, we calculated Pearson's correlation coefficients between SARC‐F‐J and TMIG‐IC, FES, and CL. Results A total of 140 subjects were included in the analysis set. Sensitivity and specificity were 16.3% and 45.0% and 95.3% and 90.8% for men and women, respectively. The positive predictive value was 81.8% for both, whereas the negative predictive value was 47.1% and 64.5% for men and women, respectively. A significant correlation was seen between SARC‐F‐J and TMIG‐IC, FES, and CL. Conclusions We believe that the SARC‐F‐J is a valid tool for patients with chronic liver disease.
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This is an exciting time with great potential for discovering therapies to improve functional capacity and decrease the high prevalence of frailty and disability in older people. The FDA will need to consider how best to incorporate the geriatric perspective into its mission. Cooperation between aging researchers, pharmaceutical companies, and regulators will be required to establish guidelines for outcome measures for the coming generation of clinical trials in frail older persons. Ultimately, all stakeholders have the same goals: reducing the burden of chronic disease and disability in older persons while avoiding harm.
Article
PurposeThe effects of supplementation with whey proteins high in leucine content were tested in older nursing home residents.Materials and methodsResident of a municipal nursing home (n = 106) were recruited to this 6-month randomized controlled trial. Both the test (n = 49) and control group (n = 57) received 1.5 deciliters of juice three times a day. The test juice was fortified with whey protein fractions (20 g/d: 75% β-lactoglobulin, 25% α-lactalbumin). The responses of muscle mass (bioimpedance spectroscopy), strength (hand grip, knee extension) and physical performance (walking, toileting) were measured. In addition to blood samples, data from comprehensive geriatric assessment were collected.ResultsWhey supplementation resulted in 2.1% increase in body weight, in contrast to 1.9% weight loss in the control group (P = 0.001). The skeletal muscle index decreased in the control group (P = 0.028), resulting in mean difference of 10.3% between groups (P = 0.039) during the first 3 months, but this difference leveled off at 6 months. The responses in muscle strength were similar, but patients on whey protein needed less physical assistance after 6 months. Insulin like growth factor 1 (IGF-1) and insulin increased in the test group, in which patients experienced less often infections, skin ulcers, and worsening of discomfort behavior.Conclusion Supplementation with whey protein fractions increases body weight and activates the IGF-1 axis in typical nursing home residents in Finland. Supplementation seems to also associate with maintenance of skeletal muscle mass, reduction in required physical assistance and general well being. However, larger well-designed trials are needed to confirm these associations.
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Article
Malnutrition is a common and often unrecognized problem in elderly persons. Every health evaluation in this population should include an assessment of nutritional status. The Mini Nutritional Assessment (MNA) is a thoroughly validated and easily used assessment tool that can detect malnourishment or the risk of malnourishment before clinical signs and allow early intervention before symptoms manifest.
Article
Background and aims: Intracellular resistance (Ri), a raw measure of bioimpedance spectroscopy (BIS), has been suggested for assessment of muscle health. The associations of repeated BIS measurements with functioning and nutritional status were investigated in nursing home residents suffering from poor health and disabilities. Methods: A total of 106 nursing home residents (age 83±8 yrs, 75% women) were recruited. Whole body and calf BIS measures (lean body mass, resistance at 50 kHz, and Ri), height and calf electrode distance (D) were used to calculate six muscle indices. Hand grip and knee extension strengths were measured and data on Activities of Daily Living (ADL), mobility score, and Mini Nutritional Assessment (MNA) collected. Repeated measurements were performed at 3 (BIS) and 6 months (BIS, muscle strength, ADL, mobility, and MNA). Results: All bioimpedance muscle indices were lower in women than men and associated with MNA. However, the calf skeletal muscle index (SMI=D2/Ri) associated with muscle strength measurements at baseline and consistently with mobility and ADL also at 6-month re-examination. When compared to the highest tertile of SMI percent change (cut point +0.7%), the patients in the lowest tertile (cut point - 11.6%) had a 5.3-fold risk (p=0.004) for mobility decline within the 6-month follow-up. This risk association also remained significant after controlling for age, gender, baseline mobility, and percent change in body weight. Conclusions: Calf intracellular resistance related to electrode distance is associated with the activities of daily living reflecting mobility in typical nursing home residents and a decrease in this index indicates a markedly increased risk for mobility decline.
Article
BACKGROUND: Much interest has been focused on nutritional treatment of sarcopenia, loss of muscle mass and performance associated to aging; however, its benefits are unclear. OBJECTIVE: To analyze the relevance of nutritional treatment of sarcopenia and assess the effects of supplementation on muscle mass and function within the aged population. METHODS: We searched Medline and the Cochrane Library for controlled trials published between 1991 and 2012. We have assessed the quality, type of intervention, the cohort used, the way muscle mass was measured, and the outcomes of the various studies. RESULTS: We have included 17 studies, with a total of 1287 patients, aged between 65 and 85 on average. An improvement in muscle mass was proven, whether measured with bioelectrical impedance analysis or dual energy x-ray absorptiometry, and an improvement in strength was also proven. CONCLUSION: Nutritional supplementation is effective in the treatment of sarcopenia in old age, and its positive effects increase when associated with physical exercise. The main limitation of this treatment is lack of long-term adherence. A healthy diet associated with a physically active lifestyle and possibly with aerobic exercise are the basis of healthy aging, which is the aim of all doctors treating aged people must seek.