The determination of sarcopenia in older adults using a practical measure

Abstract

BACKGROUND:

Many older adults are at risk of sarcopenia, a gradual loss of muscle mass affecting muscle strength and physical function, which can lead to adverse health consequences deteriorating their independence. However, the detection could be delayed due to the requirement of many measures, including a complex imaging modality. Thus, an exploration for a practical community- or home-based measure would be helpful to identify at-risk older adults and begin the timely management.

OBJECTIVE:

To explore the ability of the upper limb loading during a seated push-up test (ULL-SPUT) to determine the presence of sarcopenia in community-dwelling older adults.

METHODS:

Older adults ( $n=$ 110; 62 females, average age approximately 77 years) were cross-sectionally assessed for sarcopenia using standard measures (handgrip strength, appendicular skeletal muscle mass, and walking speed) and the ULL-SPUT.

RESULTS:

Data from standard measures indicated that 44 participants had sarcopenia. The ULL-SPUT index of $<$ 16.9 kg/m² for females (sensitivity $=$ 86%, specificity $=$ 78%, area under the receiver operating characteristic curve [AUC] $=$ 0.85) and $<$ 19.7 kg/m² for males (sensitivity $=$ 73%, specificity $=$ 69%, AUC $=$ 0.83) could optimally identify participants with sarcopenia.

CONCLUSION:

The ULL-SPUT index could be used to screen and monitor older adults with sarcopenia in various clinical, community, and home settings. This practical measure may be accomplished using a digital bathroom scale on a hard, even surface. Outcomes would identify an adult who should undergo further confirmation of sarcopenia through standard measures or the initiation of timely management to promote treatment effectiveness.

Keywords

Body composition community health services frail elderly muscle strength health status

1. Introduction

Sarcopenia can be found in up to one-third of older adults. It is a condition characterized by the loss of skeletal muscle mass (SMM), as determined using the appendicular skeletal muscle mass (ASM) index, combined with low muscle strength and/or poor physical performance due to several factors, including advancing age [1, 2, 3, 4]. The loss of these three components results in an increasing risk of physical disability, falls, osteoporosis, metabolic syndromes, and immune deterioration. Thus, apart from the effects of age-related body system decline, sarcopenia additionally enhances the risk of major adverse health consequences affecting mobility, morbidity, independence, hospitalization, and mortality, as well as quality of life of older people [5, 6, 7, 8]. Therefore, it is highly recommended that the presence of sarcopenia be identified early, while people are still functioning independently, to enable timely and effective interventions and periodic follow-up to prevent or minimize adverse health consequences and disability, particularly in this upcoming super-aged society [3, 9].

The Asian Working Group for Sarcopenia (AWGS) reported in its 2019 consensus update on sarcopenia diagnosis and treatment that the detection of sarcopenia involves the assessment of the aforementioned three components [3]. Some of these assessments require a complex imaging modality, such as dual-energy X-ray absorptiometry (DXA), magnetic resonance imaging, and computed tomography; other measurements for muscle strength and physical performance including the handgrip strength test (HG) and the 10-meter walk test (10MWT) [3, 4]. The former three imaging tests are often accessible only in a hospital setting, whereas the ability to administer the latter two tests may be limited in settings without the necessary equipment and available space. Therefore, a practical alternative measure to enable the detection of sarcopenia is needed, especially in the current era of the paradigm shift toward community- and home-based healthcare services.

Recent studies have found the benefit of the upper limb loading during a seated push-up test (ULL-SPUT) to reflect components that are involved in determining sarcopenia, including the SMM, muscle strength, and mobility of clinical populations and older adults [10, 11, 12, 13]. The present researchers hypothesized that the ULL-SPUT could be used to identify older adults with sarcopenia. However, with different rates of aging-related system decline between the sexes [12, 14], the present researchers further hypothesized that male and female participants would have different criteria for sarcopenia detection. Therefore, this study explored the ability of ULL-SPUT to identify older males and females with sarcopenia as verified using data from standard measures.

2. Materials and methods

2.1 Participants

This cross-sectional study was conducted in com-munity-dwelling adults aged 65 years and older via direct contact with community leaders. The inclusion criteria were a body mass index (BMI) of $<$ 30 kg/m², the ability to walk with or without a walking device with no more than contact guarding assistance from another person [12, 15], and the ability to understand and follow the commands used for the tests in this study. The exclusion criteria were any conditions that might confound data interpretation and affect the ability to complete the measurements of this study, such as musculoskeletal pain with a score of $>$ 5 out of 10 on a visual analog scale, unstable medical conditions (e.g., dizziness, heart disease, hypertension), and contraindications for DXA [11, 12, 13, 16]. The sample size was calculated for a diagnosis study (n $=$ [Z_{1 - α/ 2} ²p(1-p)]/d²) with an alpha level of 0.05 (Z ${}_{1-\alpha/2}=$ 1.96) and the expected proportion in population based on a previous report ( $P=$ 0.68) [17]. The findings indicated that this study required at least 46 participants per sex, or 92 participants in total. Participants signed informed consent forms that were approved by the institutional ethics committee for human research (HE 622255) prior to participation in the study.

2.2 Research protocols

Eligible participants were interviewed and assessed for their demographics (age, bodyweight, height, and underlying diseases, if any). Then they were assessed for the outcomes of the study using standard measures for sarcopenia (i.e., HG, 10MWT and DXA) and the ULL-SPUT.

2.2.1 Handgrip strength test

The HG strength test is a valid measure that is commonly used to reflect global muscle strength and functional mobility ( $r=-$ 0.568 and 0.690, $P<$ 0.001) [18, 19]. The AWGS recently suggested using HG test outcomes of $<$ 18 kg and $<$ 28 kg to indicate low muscle strength in female and male individuals, respectively [3]. In this study, participants were assessed for HG outcomes using the Southampton protocol, in which they were seated in a standard chair with armrests, their feet flat on the floor, their forearm on the armrest, and their wrist extending just over the end of the armrest in a neutral position with the thumb facing upward. Participants squeezed a Jamar handheld dynamometer (Baseline hydraulic hand dynamometer) as hard as possible in two trials with each hand, and the highest value from all trials was recorded in kilograms [12, 20, 21].

2.2.2 10-meter walk test

This test is an excellent test-retest reliability measure (intraclass correlation coefficient $=$ 0.902, $P<$ 0.001) to reflect a walking speed that is commonly used to determine those with sarcopenia, $<$ 1.0 m/s [3, 22]. Participants walked along a 10-meter walkway at a comfortable speed, with or without a walking device, and the time to navigate the 4-meter span in the middle of the walkway was recorded. The average time over three trials was converted to a walking speed in meters per second (m/s) [22, 23].

2.2.3 Dual-energy X-ray absorptiometry

In this study, DXA, a standard excellent reliability (intraclass correlation coefficient $=$ 0.997, $P<$ 0.001) and validity measure as compared with magnetic resonance imaging ( $r=$ 0.94, $P<$ 0.001) [24, 25], was used to indicate ASM and body composition of the participants at a hospital within seven days after completing the other measurements in this study. The ASM is the summation of the SMM of the four limbs [3, 4]. Participants were in a supine position on a DXA table with their arms placed at their sides, the lower limbs extended, and the toes facing upward [11, 12, 13, 26]. The ASM for the upper limbs and lower limbs was automatically generated by the machine and converted to the ASM index using the formula ASM/height². The ASM index of $<$ 5.4 kg/m² for females and $<$ 7.0 kg/m² for males was regarded as a low ASM [3].

Data from these three measures (HG strength, walking speed, and ASM index) were used to identify participants with and without sarcopenia according to the criteria from the 2019 AWGS updated consensus as showed below [3]:

Diagnosis	ASM index		HG strength		Walking speed
Possible sarcopenia			low	or	slow
Sarcopenia	low	and	low	or	slow
Severe sarcopenia	low	and	low	and	slow

Figure 1.

The upper limb loading during a seated push-up test protocol. (A) Starting position; (B) Position while lifting the body upward.

2.2.4 Upper limb loading during a seated push-up test

Previous studies reported that the ULL-SPUT of older adults significantly correlated with lean body mass (LBM; $r=$ 0.716 to 0.725, $P<$ 0.01) [12], muscle strength of the upper and lower parts of the body ( $r=$ 0.345 to 0.416, $P<$ 0.01) [13], and mobility ( $r=$ 0.247 to $-$ 0.416, $P<$ 0.05) [10]. A previous study suggests that measuring ULL-SPUT with participants seated in a ring position optimally reflects SMM in older people [10]. Therefore, in this study, participants were assessed for the ULL-SPUT in a ring sitting position. The ULL-SPUT was measured using push-up loading devices that were developed from digital load cells (Model L6E3-C, 50 kg-3G, with a standard calibration method based on United Kingdom Accreditation Service [UKAS] LAB 14: 2006 with accuracy up to $<$ 0.01 kg and a measurement uncertainty of $\pm$ 0.2 kg; mini-patent number 20633) based on the concept of a digital bathroom scale in the size of standard clinical push-up boards (Fig. 1). Participants placed both hands on the handlebars of the push-up loading device, which was positioned slightly in front of their hips. Then, they pushed both hands against the device, lifted their body up from the floor while bending the trunk forward, and then bent the elbows to place the buttocks smoothly on the floor [10, 12, 13]. The average ULL-SPUT data as they could do maximally, regardless of the ability to lift up from the floor successfully, over three trials were reported in kilograms. Then the outcomes were converted to the ULL-SPUT index using the formula ULL-SPUT/height² (kg/m²) for the outcomes to be comparable among the participants, similar to the ASM index [27].

2.3 Statistical analysis

Descriptive statistics were used to explain the participants’ demographics and findings of the study, separately for male and female participants. Participants with no sarcopenia and possible sarcopenia were assigned to the non-sarcopenia group, and those with sarcopenia and severe sarcopenia were assigned to the sarcopenia group. The differences between the groups of each sex were compared using the independent samples $t$ test for the continuous variables and the $\chi^{2}$ test for the categorical variables. The receiver operating characteristic (ROC) curves were further used to estimate the appropriate cutoff scores with a certain sensitivity, specificity, and area under the ROC curve (AUC) for the ability of the ULL-SPUT to identify participants with sarcopenia. The levels of AUC were identified as low (AUC $<$ 0.7), acceptable (AUC $=$ 0.7–0.8), excellent (AUC $=$ 0.8–0.9), and outstanding (AUC $>$ 0.9) [28]. The level of statistical significance was set at $P<$ 0.05.

Table 1
Demographics and health status of participants

Variable	Female participants ( $n=$ 62)		$p$ -value	Male participants ( $n=$ 48)		$p$ -value
	Non-sarcopenia ( $n=$ 44)	Sarcopenia ( $n=$ 18)		Non-sarcopenia ( $n=$ 22)	Sarcopenia ( $n=$ 26)
Age (years)^a	73.2 $\pm$ 5.8 (71.5 to 75.0)	80.4 $\pm$ 7.5 (76.7 to 84.2)	$<$ 0.001^*	74.9 $\pm$ 7.9 (71.3 to 78.4)	78.1 $\pm$ 5.5 (75.8 to 80.3)	0.053
Weight (kg)^a	53.1 $\pm$ 7.1 (50.9 to 55.2)	41.4 $\pm$ 6.1 (38.4 to 44.5)	$<$ 0.001^*	62.6 $\pm$ 8.2 (59.0 to 66.3)	53.9 $\pm$ 7.3 (50.9 to 56.8)	$<$ 0.001^*
Height (m)^a	1.5 $\pm$ 0.1 (1.5 to 1.5)	1.5 $\pm$ 0.1 (1.5 to 1.5)	0.122	1.6 $\pm$ 0.1 (1.56 to 1.6)	1.61 $\pm$ 0.06 (1.6 to 1.6)	0.272
Body mass index (kg/m²)^a	23.9 $\pm$ 2.5 (23.2 to 24.7)	19.2 $\pm$ 2.7 (17.9 to 20.5)	$<$ 0.001^*	24.4 $\pm$ 2.7 (23.1 to 25.6)	20.7 $\pm$ 2.2 (19.8 to 21.6)	$<$ 0.001^*
Walking device^b			0.032^*			0.454
No	36 (81.8)	10 (55.6)		20 (90.9)	25 (96.12)
Yes	8 (18.2)	8 (44.4)		2 (9.1)	1 (3.9)
Cane	8 (18.2)	6 (33.3)		2 (9.1)	1 (3.9)
Walker	0 (0.0)	2 (11.1)		0 (0.0)	0 (0.0)
Medical conditions: number (%)			0.175			0.961
No	23 (52.3)	6 (33.3)		10 (45.5)	12 (46.2)
Yes (1–4 medical conditions)	21 (47.7)	12 (6.7)		12 (54.6)	14 (53.9)
Medication use^b			0.212			0.976
No	25 (56.8)	7 (38.9)		9 (40.9)	11 (42.3)
1–3	18 (40.9)	9 (50.0)		10 (45.5)	12 (46.2)
4 and more	1 (2.3)	2 (11.1)		3 (13.6)	3 (11.5)

Table 2

Outcomes of male and female participants with and without sarcopenia

Variable	Female participants ( $n=$ 62)		$p$ -value	Male participants ( $n=$ 48)		$p$ -value
	Non-sarcopenia ( $n=$ 44)	Sarcopenia ( $n=$ 18)		Non-sarcopenia ( $n=$ 22)	Sarcopenia ( $n=$ 26)
Handgrip test (kg)^a	16.8 $\pm$ 4.6 (15.4 to 18.2)	12.8 $\pm$ 3.3 (11.2 to 14.5)	$<$ 0.001^*	24.1 $\pm$ 5.3 (21.8 to 26.5)	21.5 $\pm$ 3.1 (20.3 to 22.7)	0.018^*
10-meter walk test (m/s)	0.9 $\pm$ 0.2 (0.9 to 1.0)	0.8 $\pm$ 0.3 (0.6 to 0.9)	0.027^*	1.0 $\pm$ 0.2 (0.9 to 1.0)	0.9 $\pm$ 0.2 (0.8 to 1.0)	0.206
ULL index (kg/m²)	19.4 $\pm$ 2.7 (18.6 to 20.1)	14.2 $\pm$ 4.2 (12.1 to 16.2)	$<$ 0.001^*	21.2 $\pm$ 2.6 (20.0 to 22.4)	18.0 $\pm$ 2.1 (17.1 to 18.5)	$<$ 0.001^*
ASM index (kg/m²)	6.3 $\pm$ 0.5 (6.1 to 6.4)	4.9 $\pm$ 0.5 (4.7 to 5.2)	$<$ 0.001^*	7.3 $\pm$ 0.5 (7.3 to 7.8)	6.3 $\pm$ 0.5 (6.1 to 6.6)	$<$ 0.001^*
Lean body mass (kg)	31.9 $\pm$ 3.2 (31.0 to 32.9)	26.20 $\pm$ 2.7 (24.86 to 27.5)	$<$ 0.001^*	43.0 $\pm$ 2.8 (41.7 to 44.2)	38.3 $\pm$ 4.1 (36.6 to 40.0)	$<$ 0.001^*
Bone mineral content (kg)	1.6 $\pm$ 0.3 (1.5 to 1.6)	1.3 $\pm$ 0.2 (1.2 to 1.4)	$<$ 0.001^*	2.3 $\pm$ 0.4 (2.2 to 2.5)	2.3 $\pm$ 0.4 (2.1 to 2.5)	0.238
Fat mass (kg)	19.5 $\pm$ 4.5 (18.1 to 20.8)	13.7 $\pm$ 4.9 (11.3 to 16.1)	$<$ 0.001^*	17.2 $\pm$ 5.6 (14.7 to 19.7)	13.0 $\pm$ 4.9 (11.1 to 15.0)	0.004^∗

3. Results

3.1 Participants

A total of 110 community-dwelling older adults (62 females) with an average age of approximately 77 years and a normal BMI completed the study (Table 2). Data from standard measures indicated that 40% of participants ( $n=$ 44; 18 females and 26 males) had sarcopenia. Of all participants with sarcopenia, 12 female participants (66.7%) and 14 male participants (53.8%) had underlying conditions (ranged from 1–4 types). These participants were significantly older, with ASM, LBM, bone mineral content (BMC), and body fat mass significantly lower than those without sarcopenia ( $P<$ 0.05; Tables 2 and 2). Moreover, those with sarcopenia had a significantly lower BMI along with lower HG strength, ASM index, ULL-SPUT, and ULL-SPUT index than participants without sarcopenia ( $P<$ 0.05; Table 2). The female participants with sarcopenia included those who used a walking device and walked significantly slower than those without sarcopenia ( $P<$ 0.05; Tables 2 and 2).

Figure 2.

The data distribution, cutoff score, sensitivity, specificity, and areas under the receiver operating characteristic curves (AUC) of the upper limb loading during a seated push-up test (ULL-SPUT) index of the participants.

3.2 Cutoff scores to detect the presence of sarcopenia

The ROC analysis indicated that the ULL-SPUT index of $<$ 16.9 kg/m² (sensitivity $=$ 86%, specificity $=$ 78%, AUC $=$ 0.85) and $<$ 19.7 kg/m² (sensitivity $=$ 73%, specificity $=$ 69%, AUC $=$ 0.83) could determine the presence of sarcopenia among female and male participants, respectively (Fig. 2).

4. Discussion

In light of the current healthcare paradigm shift toward providing standardized community and home healthcare services, this study investigated the ability of a practical measure, namely the ULL-SPUT index, to identify older adults living with sarcopenia. The findings indicated that nearly half of the participants (40%) had sarcopenia, according to the data from standard criteria. These participants were significantly older, with LBM, BMC, and body fat mass lower than those without sarcopenia ( $P<$ 0.05; Tables 2 and 2). In addition, participants with sarcopenia demonstrated poor physical performance as measured using the 10MWT ( $<$ 1.0 m/s, $P<$ 0.05; Table 2). The ROC analysis indicated that the ULL-SPUT index of $<$ 16.9 kg/m² for females and $<$ 19.7 kg/m² for males demonstrated an excellent ability to indicate the presence of sarcopenia among the participants (Fig. 2).

The findings reflect natural characteristics of individuals with sarcopenia, a condition of age-related SMM loss affecting ASM, muscle strength, and/or physical performance [29, 30, 31]. These characteristics were particularly evidenced in female participants, all of whom had low muscle strength, ASM index, and body composition along with slow walking speed (Table 2). Lean body mass is important for protection against frailty, physical dysfunction, and adverse health conditions [31, 32, 33]. Appendicular skeletal muscle is needed for protein synthesis of the body’s organs and force generation for mobility and independence [31, 33, 34]. Low BMC is associated with the presence of osteopenia, osteoporosis, deformity, and fractures. These findings were important particularly when the participants were well-functioning but the findings suggest the internal deterioration that could further affect their health and independence. These people are also accounted as having a high risk of fall and subsequent injury, and up to 75% of older adults who sustained a hip fracture after falling did not regain their prior level of function [14, 23, 32]. Furthermore, older adults who are admitted to a hospital because of a fall are likely to experience subsequent disability and nursing home placement [35, 36]. Cesari et al. [37] also reported that older adults with a usual walking speed slower than 1 m/s were those with a high risk of poor health-related outcomes. Therefore, these findings confirm the need for a strategy to identify those with sarcopenia early to prevent or minimize the adverse health consequences and disability associated with this condition.

The present findings suggest that the ULL-SPUT index of $<$ 16.9 kg/m² for females and $<$ 19.7 kg/m² for males has an excellent ability to identify participants with sarcopenia (Fig. 2). The findings reflect characteristics of the test, whereby the ability to increase ULL-SPUT requires complex interaction among many muscles of the upper limbs and upper trunk acting in a closed-kinetic chain manner against the bodyweight [11, 38]. Such ability requires muscle strength and perceptual information to increase joint torques, muscle force, and power while lifting the body up from the floor and maintaining body balance at the shoulder [38]. Thus, the ability to increase ULL-SPUT requires adequate SMM to enable muscles to convert chemical energy into mechanical energy for force and power generation while producing movements and maintaining body balance at the shoulder joints [39, 40]. A previous study reported that approximately 75% of SMM is located in the appendicular regions as the so-called ASM, an essential component for the sarcopenia diagnosis [41]. Then, the global physiological changes occurring throughout the body enable the ability of the test involving complex upper limb and upper trunk muscles to reflect mobility of older participants [13, 14, 40].

With the involvement of bodyweight while lifting the body upward, the ULL-SPUT data in this study were additionally adjusted for each participant’s height, similar to that of the ASM index as proposed by previous reports [3, 27], so the data would be comparable among the participants. The findings are in agreement with previous reports that found the association between the ability to perform the ULL-SPUT and muscle strength, body composition, and mobility of older people with and without sarcopenia [10, 12, 13, 42].

Handgrip strength is a well-investigated measure to assess the small muscles of the upper limb that are susceptible to decline with age. Global physiological changes enable its outcomes to reflect overall muscle strength and detect abnormalities in older adults [43]. However, execution of the HG strength test in an open-kinetic chain manner (i.e., squeezing the tested hand maximally without the involvement of the bodyweight) could reduce its challenge, therefore reducing the ability of the outcomes to reflect body composition when the rate of age-related reduction in muscle strength is three times greater than the rate of SMM decline [44, 45, 46]. Therefore, the HG strength test must be used in combination with the other body composition and physical performance measures to detect sarcopenia [3].

With the need of a practical standard strategy to distribute effective community- and home-healthcare services, the present findings suggest the use of the ULL-SPUT index as an alternative practical measure, perhaps accomplished using digital bathroom scales, to identify sarcopenia in community-dwelling older adults. Then standard measures can be further implemented to confirm the abnormality and early interventions initiated to promote treatment effectiveness.

Nonetheless, this study has some limitations needed to be concerned for clinical implication. Older adults with sarcopenia commonly have low BMI; thus, this study recruited participants with a BMI $<$ 30 kg/m² to minimize confounding factors for the ability of lifting the body upward for the ULL-SPUT assessments. In addition, as the first study applying the ULL-SPUT index in older adults with sarcopenia, this study recruited participants who needed no more than contact guarding assistance from another person. These may be the reasons why most participants had no clear functional deterioration, and the comorbidities showed no significant differences between the groups with and without sarcopenia in both males and females (Tables 2 and 2). Furthermore, the AWGS 2019 consensus [3] recommends that the 10MWT measure the time it takes the participant to walk over 6 meters at a normal pace from a flying start, but this study applied a flying start over a 4-meter span in the middle of the 10-meter walkway to achieve a rhythmic walking speed and minimize the effects of acceleration and deceleration on the outcomes. However, a recent study found no clear difference between the outcomes of walking speed over a long and a short distance [22]. Therefore, a further study may explore the use of the ULL-SPUT index in older adults with poor mobility with a wide range of BMIs using standard testing protocols to enhance the clinical implication of the ULL-SPUT index for sarcopenia detection. Moreover, the suggestion for performing ULL-SPUT index measurement using digital bathroom scales may need further verification to support the validity of its use.

5. Conclusions

With the need for practical measures to promote standard community and home healthcare services, the present findings suggest the use of the ULL-SPUT index of $<$ 16.9 kg/m² and $<$ 19.7 kg/m² to indicate the presence of sarcopenia in male and female older adults, respectively. Such a measure may be assessed using a digital bathroom scale over a hard, even surface. Then, standard measures can be further applied to confirm the abnormality and initiate early interventions so that the subsequent adverse health consequences and disability related to sarcopenia are prevented or minimized, particularly in this upcoming super-aged society.

Author contributions

All authors were responsible for the research conceptualization, study design, and final approval of the manuscript. PC, PP and RI were involved in data collection. PC was engaged in statistical analysis, data interpretation, and drafting the manuscript. SA and TT were responsible for funding application. SA worked on research management, data interpretation, and finalized the manuscript. All authors read and approved the final manuscript.

Data availability statement

All relevant data are included within this manuscript and raw data are archived by the corresponding author.

Compliance with ethical standards

All procedures of the study were in accordance with the standards of the Ethics Committee for Human Research (HE 622255). Eligible participants completed a written informed consent form before participation in this study.

Footnotes

Acknowledgments

This research was supported by the Fundamental Fund (2024) and Research and Graduate Studies, Khon Kaen University (RP64016), Khon Kaen University, Thailand.

Conflict of interest

The authors declare no potential conflicts of interest.

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The determination of sarcopenia in older adults using a practical measure

Abstract

BACKGROUND:

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSION:

Keywords

1. Introduction

2. Materials and methods

2.1 Participants

2.2 Research protocols

2.2.1 Handgrip strength test

2.2.2 10-meter walk test

2.2.3 Dual-energy X-ray absorptiometry

2.3 Statistical analysis

Table 1 Demographics and health status of participants

3.1 Participants

4. Discussion

5. Conclusions

Author contributions

Data availability statement

Compliance with ethical standards

Footnotes

Acknowledgments

Conflict of interest

References

Table 1
Demographics and health status of participants