Abstract
Background
Frailty is a geriatric syndrome characterized by increased vulnerability to stressors and is more prevalent among women. As a dynamic condition, its progression can be prevented through early interventions. Therefore, this study aimed to evaluate the effect of Salutogenic Model-Based Frailty Prevention Program (SAFRAPP) among pre-frail women on preventing development of frailty and improving sense of coherence (SOC).
Methods
A single-blinded, two-arm randomized controlled trial was conducted with a total of 84 pre-frail women aged 55 years and older. Participants were randomly assigned to the intervention group (n = 42) or the control (n = 42) groups. SAFRAPP was implemented in the intervention group for six weeks and consisted of health education, case management, and laughter yoga. The primary outcomes were frailty status and SOC. Secondary outcomes were well-being, quality of life, fear of falling, number of falls, and emergency visits. Data were collected at baseline and at 3-month, 6-month, and 9-month follow-ups from both groups. Pearson’s chi-square test, independent samples t-test and repeated measures analysis of variance were used for data analysis.
Results
The results revealed that nearly half of the pre-frail women in the intervention group transitioned to a robust stage, showing a statistically significant improvement compared to the control group at the 3-month, 6-month, and 9-month follow-ups (p < 0.001). The intervention group showed a significant improvement in SOC and well-being at the 3-month, 6-month, and 9-month follow-ups (p < 0.001). There was a significant improvement in quality of life and a reduction in fear of falling between baseline, 3-month, and 6-month assessments. However, the SAFRAPP group showed no significant change in falls and emergency visits over time compared to the control group (p > 0.05).
Conclusions
A nurse-led multicomponent intervention based on the Salutogenic Model appears to be effective in preventing the progression of frailty, improving sense of coherence, well-being, and quality of life among women aged 55 years and older. Future studies should investigate the potential for SAFRAPP in diverse populations and healthcare settings.
Trial registration
ClinicalTrials.gov Identifier: NCT04787432, date of registration: 08/03/2021.
Keywords: Aging, Frailty, Prevention, Salutogenesis, Sense of coherence, Women
Background
Frailty is a common geriatric syndrome characterized by a decline in physiological reserves and increased vulnerability to stressors [1, 2]. The prevalence of frailty, a condition closely associated with aging, is expected to rise globally due to demographic shifts and increasing life expectancy [3, 4]. In community-dwelling elderly populations, the prevalence of frailty varies by age, ranging from 4 to 59% [3]. As frailty is a dynamic condition, characterized by both progression and reversion, early screening and interventions are crucial for preventing adverse health outcomes, including falls, hospitalizations, functional decline, dependency in daily activities, and an increased risk of mortality [5–7].
The Fried Frailty Phenotype Model, based on the Cardiovascular Health Study, categorizes individuals as frail, prefrail, or robust based on symptoms such as involuntary weight loss, fatigue, muscle weakness, slow walking speed, and reduced physical activity. Pre-frailty is a clinically silent process that exists between robustness and frailty, predisposing individuals to frailty [2]. A meta-analysis of 46 studies revealed that 12 to 151 out of every 1,000 healthy older individuals experience frailty or pre-frailty annually [8]. In Türkiye, nearly half of individuals aged 65 and over were in a pre-frail stage, a risky period before frailty, according to Eyigor et al. (2015) [9]. In addition, women are more likely than men to be frail [8, 9]. The FrailTURK study showed that 45% of women and 29% of men were frail and 41% of women and 47% of men were pre-frail in Türkiye [9]. Due to the higher prevalence of frailty among women compared to men, it is recommended to implement gender-specific frailty prevention programs [10].
Many studies have focused on the physical dimension of frailty through interventions such as physical activity, nutritional supplements, and hormone supplementation [7, 11]. However, recent studies emphasize the need to address frailty as a multidimensional state, incorporating psychological, and social aspects in addition to its physical nature [12, 13]. A systematic review of 20 studies found that multidimensional interventions were more effective than single-dimensional ones in addressing frailty [12]. For example, a 12-week nurse-led health education, cognitive training, disease management, and exercise intervention was found to reduce frailty levels [14]. However, studies indicate that interventions targeting psychological and social dimensions remain insufficient [12, 13]. Health promotion programs should be planned to reduce the risk of frailty [1, 15]. At this point, there is a need for studies involving model-based health promotion programs aimed at preventing the transition to frailty in at-risk individuals [15].
In recent years, many interventional studies have focused on strengthening the sense of coherence (SOC) [16–18]. The SOC is a core concept of the Salutogenic Model, referring to an individual’s ability to cope with stressors. The Salutogenic Model was developed by Aaron Antonovsky, a medical sociologist, who introduced the concept in 1979 [19]. The model focuses on empowering individuals to respond effectively to stressful life situations, rather than emphasizing factors that cause disease. Generalized Resistance Resources (GRRs), another core concept of the model, contribute to strengthening SOC, which represents an individual’s capacity to manage and adapt to stressors [19, 20]. According to the Salutogenic Model, a person’s SOC is shaped by life experiences, which enhance their capacity to effectively mobilize resources and manage stress [19]. The three main components of SOC are manageability, meaningfulness, and comprehensibility. Comprehensibility is the cognitive component of SOC, relating to an individual’s ability to understand their environment and experiences. Manageability is the behavioral component, involving the resources available to cope with challenges, while meaningfulness reflects the belief in the purpose and significance of life, driving motivation and effort [19, 20]. Studies have shown that individuals with a strong sense of coherence tend to have better physical and mental health outcomes [21, 22].
To the best of our knowledge, this is the first study evaluating whether the Salutogenic Model based interventions prevent the development of frailty and improve SOC among pre-frail older women in Turkiye. Therefore, this study aimed to evaluate the effect of Salutogenic Model-Based Frailty Prevention Program (SAFRAPP) among pre-frail women on preventing development of frailty, improving SOC, well-being and quality of life, and reducing fear of fall, and number of falls and emergency admissions. The hypotheses of the research are stated below:
H1. The proportion of robust women in the intervention group is higher than that in the control group after the SAFRAPP.
H2. The proportion of frail women in the intervention group is lower than that in the control group after the SAFRAPP.
H3. The level of SOC in the intervention group is higher than that in the control group after SAFRAPP.
H4. The level of well-being in the intervention group is higher than that in the control group after SAFRAPP.
H5. The level of quality of life in the intervention group is higher than that in the control group after SAFRAPP.
H6. The level of fear of fall in the intervention group is lower than that in the control group after SAFRAPP.
H7. The number of falls in the intervention group is lower than that in the control group after SAFRAPP.
H8. The number of emergency admissions in the intervention group is lower than that in the control group after SAFRAPP.
Methods
Design
The Salutogenic Model-Based Frailty Prevention Program (SAFRAPP), a single-blinded, two-armed randomized controlled study, was conducted among 84 pre-frail women aged 55 and over between December 2020 and December 2022. Ethical approval and institutional permission were obtained from the Ethics Committee for the Social Sciences and Humanities (IRB Number: 2019/62) and the center of vocational institutions in a municipality (dated: February 2, 2020) in Türkiye. In the study protocol was registered with ClinicalTrials.gov (identifier number: NCT04787432, registration date: 08/03/2021), and has been published [23]. This article reports the primary (frailty and sence of coherence) and secondary outcomes (well-being, quality of life and fear of fall, and number of falls and emergency admissions). The CONSORT 2010 guidelines were used to report the study. Figure 1 presents the CONSORT flow diagram.
Fig. 1.
Consort flow diagram of the study
Setting and sampling
The study was conducted in vocational institutions within a municipality in Istanbul between December 2020 and 2022. As frailty prevalence increases with age, older adults are at a higher risk of developing frailty [3, 7]. This study specifically focused on individuals classified as pre-frail, a stage preceding frailty, to facilitate early detection and preventive interventions. Eligible participants met the following criteria: (1) women aged 55 years or older (2), classified as pre-frail (3), ability to communicate in Turkish (4), access to the internet, and (5) willingness to provide informed consent. In this study, the 55-year threshold was chosen because it represents the age at which prefrailty becomes observable, yet interventions can still prevent or delay progression to frailty [24]. Exclusion criteria included: (1) cognitive, psychiatric, or neurological disorders (2), semi-dependence or dependence with Katz Index of Independence in Activities of Daily Living score < 6 [25] (3) recent surgical history (within the past three months), and (4) communication barriers due to hearing or vision impairment.
The sample size was calculated using G*Power 3.1 software based on the primary outcome measure, frailty score. Based on prior research [26], an effect size of 0.27 was determined, and a total sample size of 84 participants (42 per group) was established to achieve 80% power at a 0.05 significance level.
Randomization
Following baseline assessment, participants were randomised to the intervention group (IG) or control group (CG), with stratification by age (55–65 years vs. 65 years and older) and number of medications used (< 4 vs. ≥4). The medication threshold was established based on evidence that frailty risk increases significantly at four or more medications [27]. Randomization was managed by an independent person, using a computer-generated random number sequence. The researcher delivering the SAFRAPP intervention was aware of group assignments to ensure correct implementation, while participants and the data analyst were blinded to allocation. Although more than one party was blinded, the design is described as single-blind in accordance with conventions for behavioral intervention studies where the interventionist cannot be blinded due to the nature of the program.
Intervention: SAFRAPP
The SAFRAPP has been explained in detail in the study protocol published in 2022 [23]. It was designed as a nurse-led, 6-week online program based on the Salutogenic Model. The Salutogenic Model emphasizes people’s resistance resources for handling stressful situations while enhancing their sense of coherence [20]. Before a person becomes frail, they may experience pre-frailty, a reversible risk state associated with an inability to cope with stressors [7]. Targeting pre-frail older women, the program incorporates multidimensional interventions, including health education, case management, and laughter yoga. The intervention was delivered via digital platforms, with laughter yoga and health education conducted through Facebook Messenger Room and case management through WhatsApp video calls. Laughter yoga was implemented as a group-based activity with twice-weekly 40-minute sessions, led by the researcher (MAY) who was a certified laughter yoga leader. Laughter yoga was designed as a non-invasive complementary therapy by Madan Kataria in 1995 [28]. It included breathing exercises, rhythmic clapping, and guided laughter exercises to promote physical and psychological well-being [28–30]. After all laughter yoga sessions were completed, group health education was provided twice a week for 20 min, covering topics including the concepts of health, frailty, and general sources of resistance to frailty; common medical conditions and medication use; physical activity; a healthy diet; fall prevention; and cognitive and psychosocial health. Case management consisted of weekly individual sessions using a standardized terminology model, the Omaha System, to assess needs, provide guidance, and refer participants to appropriate resources [31]. In addition to their regular activities at vocational institutions, participants in the control group did not receive any additional interventions.
Control group: Usual activities
Participants in the CG did not receive any additional interventions and continued attending courses at vocational institutions within the municipality, with no modifications to their daily routines.
Measurements
Descriptive characteristics form
This form consists of 13 questions addressing women’s sociodemographic and health characteristics. It also includes items on fear of falling, the number of falls, and the number of emergency admissions. Fear of falling was assessed using a single question: Are you afraid of falling? Responses were scored on a 1–4 points of ‘never afraid (1),’ ‘sometimes afraid (2),’ ‘afraid (3),’ and ‘always afraid (4)’, with higher scores indicating greater fear of falling [32]. Additionally, women were asked to report the number of falls and emergency admissions they had experienced in the past three months.
The FRAIL scale
It is a five-item self-assessment tool used to evaluate fatigue, resistance, ambulation, weight loss, and illnesses, with each item scored as either 1 or 0. The total score ranges from 0 to 5, with classifications as follows: 0 = non-frail, 1–2 = pre-frail, and > 2 = frail. This self-assessment scale was developed by Morley et al. (2012) [33] and adapted for Turkish culture by Hymabaccus Muradi et al. in 2017 [34]. The FRAIL Scale showed a strong correlation with other frailty assessment tools, such as the FIND scale and the Fried Index, with correlation coefficients of 0.956 and 0.934, respectively. The scale also had high reliability, with a Cronbach’s alpha internal consistency coefficient of 0.79 [34].
The sense of coherence scale (SOC)
This 13-item, 7-point Likert-type scale was developed by Antonovsky to assess the SOC [19]. The scale was translated into Turkish by Scherler and Lajunen and retains three dimensions: comprehensibility, manageability, and meaningfulness. The total score ranges from 13 to 91, with higher scores indicating a stronger sense of coherence [35]. For the Turkish version of the SOC-13, Lajunen reported an internal consistency coefficient of 0.69 for the Turkish population [35]. This version has been utilized in both past and recent studies in Türkiye [36–38].
The World Health Organization-Five Well-Being index (WHO-5)
The WHO-5, developed by the World Health Organization and validated in Turkish by Eser et al. (2019), is a five-item measure rated on a 6-point scale [39]. It assesses overall mental well-being based on experiences over the past two weeks, with higher scores indicating better mental well-being. The total score ranges from 0 to 25, with higher values reflecting a more positive emotional state. To standardize the results, the total score is multiplied by 4, converting it to a 0–100 scale, where higher scores denote greater well-being. The scale exhibits good internal consistency, with a reported Cronbach’s α of 0.81 [39].
The European quality of life five dimensions three level questionnaire (EQ-5D-3 L)
The EQ-5D-3 L scale, developed by the EuroQOL Group, is designed to assess health-related quality of life [40]. In the validity and reliability study of the Turkish version, the internal consistency coefficient was reported as 0.86 [41]. The EQ-5D-3 L consists of two sections: the descriptive system and the EQ Visual Analogue Scale (VAS). The descriptive system evaluates participants’ mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Participants are asked to rate their health status on each dimension using the following scale: (1) no problems (2), some problems, or (3) severe problems. The second section, the vertical VAS, is an analog scale that measures a person’s subjective assessment of their health, ranging from 0 to 100 [40].
Data collection
Data were collected at baseline and at 3-month, 6-month, and 9-month follow-ups from both the IG and CG through online surveys. Prior to the baseline assessment, institution managers disseminated the online informed consent form via social media and WhatsApp groups. Baseline data were obtained from women who provided informed consent before randomization. An independent individual randomized participants into either the IG or CG using a computer-generated random number sequence. Following randomization, the SAFRAPP schedule was determined in consultation with participants in the IG. The intervention lasted for six weeks, and reminder messages were sent before each session to enhance adherence. Participants were provided with the researcher’s contact information to report any adverse effects or seek assistance, and they were informed that they could withdraw from the SAFRAPP intervention at any time. Women in the CG who expressed interest in participating were also provided with SAFRAPP after the study concluded. A digital certificate of attendance was received to participants after the follow-up assessments.
Statistical analysis
Statistical analyses were performed using SPSS 26.0 (Statistical Package for the Social Sciences 26.0) and R version 2.15.3 (R Core Team, 2013). The normality of the data was assessed using the Shapiro-Wilk test and graphical inspections. Descriptive analyses (mean, standard deviation, percentage, median, minimum, maximum), Pearson’s chi-square test, Fisher-Freeman-Halton Exact test, Fisher’s Exact test, and Independent Samples t-test were used to compare the homogeneity of the IG and CG. The Independent Samples t-test was used to compare pre-test and post-test data between groups. Measurements taken at four different time points were evaluated using repeated measures analysis of variance and Bonferroni-corrected post-hoc tests. Partial eta-squared (η²) was evaluated in the study to measure the effect size. To ensure the impact of randomization was preseved despite sample loss, Intention-to-Treat (ITT) analyses were conducted. A significance level of p < 0.05 was considered statistically significant in this study.
Results
Table 1 presents descriptive features of the women in the IG and CG. No statistically significant difference was found between the IG and CG in terms of socio-demographic and health characteristics (p > 0.05) (Table 1).
Table 1.
Descriptive features of the women in the intervention and control groups
| Variables | Intervention (n = 42) | Control (n = 42) | ||
|---|---|---|---|---|
| M (SD) | M (SD) | t | p | |
| Age | 62.67 (6.79) | 61.57 (7.47) | 0.703 | 0.484 |
| Number of health problem | 1.66 (1.4) | 1.41 (1.57) | 0.735 | 0.465 |
| Number of medication use | 2.03 (1.67) | 1.76 (2.03) | 0.628 | 0.532 |
| n (%) | n (%) | χ2 | p | |
| Marital status | ||||
| Married | 30 (71.4) | 32 (76.2) | 1.797a | 0.655 |
| Single | 12 (28.5) | 10 (23.9) | ||
| Education status | ||||
| Primary school | 8 (19) | 7 (16.7) | 2.252a | 0.516 |
| Secondary school | 3 (7.1) | 6 (14.3) | ||
| Higher school | 15 (35.7) | 18 (42.9) | ||
| University and above | 16 (38.1) | 11 (26.2) | ||
| Place of residence | ||||
| Apartment | 42 (100) | 40 (95.2) | 2.049b | 0.494 |
| Detached house | 0 (0) | 2 (4.8) | ||
| Household composition | ||||
| Alone | 12 (28.6) | 7 (16.7) | 2.471a | 0.302 |
| Family | 30 (71.4) | 34 (81) | ||
| Caregiver | 0 (0) | 1 (2.4) | ||
| Employment status | ||||
| Yes | 1 (2.4) | 5 (11.9) | 3.644a | 0.155 |
| No | 41 (97.7) | 37 (88.4) | ||
| Income status | ||||
| Poor | 1 (2.4) | 0 (0) | 0.974a | 0.999 |
| Moderate | 28 (66.7) | 29 (69) | ||
| Good | 13 (31) | 13 (31) | ||
| Smoking status | ||||
| Everyday | 4 (9.5) | 6 (14.3) | 0.638a | 0.959 |
| Occasionally | 2 (4.8) | 2 (4.8) | ||
| Never | 26 (61.9) | 25 (59.5) | ||
| Quit | 10 (23.8) | 9 (21.4) | ||
| Alcohol use | ||||
| Yes | 2 (4.8) | 4 (9.5) | 1.709a | 0.438 |
| No | 40 (95.2) | 38 (90.5) | ||
Abbreviation: t, Independent-samples t-test; χ2: Chi-squared test
aFisher-Freeman-Halton exact test, bFisher’s exact test
Figure 2 presents the changes in the proportion of robust and frail women in the IG and CG over time following the intervention. In the IG, the proportion of robust women was 42.1% (n = 16) at both the 3rd and 6th months, and 36.8% (n = 16) at the 9th month. In contrast, in the CG, there were almost no women transitioning from pre-frail to robust status at the 3rd month (n = 0), 6th month (n = 1, 2.7%), and 9th month (n = 0). The increase in robust women in the IG was statistically significant compared to the CG at the 3rd month (χ²=19.804, p < 0.001), 6th month (χ²=16.604, p < 0.001), and 9th month (χ²=16.760, p < 0.001). No women in the IG became frail over time, whereas the proportion of frail women in the CG was 3rd month: 2 (5.4%), 6th month: 2 (5.4%), and 9th month: 5 (13.5%), with a significant difference at the 9th month (χ²=5.502, p = 0.025). Thus, H1 and H2 were accepted.
Fig. 2.
The changes in outcomes in the intervention and control groups over time
The mean SOC total scores of women in the SAFRAPP group were significantly higher than those in the CG at the 3rd, 6th, and 9th months (t = 9.824, t = 5.719, t = 5.061, respectively; p < 0.001). The mean total score of the comprehensibility, the manageability, and the meaningfulness subscales respectively were also higher in the IG compared to the CG across all time points (p < 0.001). In within-group comparisons, the changes in the mean SOC total and subscale scores over time were statistically significant compared to the baseline scores in the SAFRAPP group (p < 0.001) (Table 2). Thus, H3 was supported.
Table 2.
Comparison of primary outcomes scores in the intervention and control groups
| Primary outcomes | Intervention (n = 38) | Control (n = 37) | tb/ p | ||
|---|---|---|---|---|---|
| M(SD) | M(SD) | η² | |||
| Frailty status | Baseline | 1.29 (0.46) | 1.21 (0.42) | 0.749/ 0.456 | 0.28 |
| 3 month | 0.67 (0.57) | 1.29 (0.55) | -5.047/ <0.001* | ||
| 6 month | 0.67 (0.57) | 1.26 (0.59) | -4.714/ < 0.001* | ||
| 9 month | 0.76 (0.62) | 1.38 (0.76) | -4.086/ < 0.001* | ||
| Fa/ p | 27.830/ <0.001* | 3.689/ 0.054 | |||
| SOC | Baseline | 58.71 (12.17) | 57.81 (9.78) | 0.376/ 0.708 | 0.56 |
| 3 month | 73.52 (5.86) | 57.6 (8.72) | 9.824/ <0.001* | ||
| 6 month | 66.4 (7.23) | 56.69 (8.3) | 5.719/ <0.001* | ||
| 9 month | 65.4 (6.22) | 56.62 (9.38) | 5.061/ <0.001* | ||
| Fa/ p | 93.449/ <0.001* | 1.829/ 0.145 | |||
| Comprehensibility | Baseline | 22.19 (5.46) | 21.62 (4.4) | 0.528/ 0.599 | 0.50 |
| 3 month | 28.31 (2.65) | 21.98 (4.45) | 7.917/ <0.001* | ||
| 6 month | 24.45 (3.74) | 21.62 (4.21) | 3.261/ 0.002* | ||
| 9 month | 24.21 (3.46) | 21.93 (5.01) | 2.433/ 0.017* | ||
| Fa/ p | 72.009/ 0.001* | 0.702/ 0.545 | |||
| Manageability | Baseline | 17.69 (4.6) | 17.31 (3.29) | 0.436/ 0.664 | 0.42 |
| 3 month | 22.21 (2.39) | 17.14 (2.77) | 8.972/ <0.001* | ||
| 6 month | 19.93 (2.7) | 17.31 (3.03) | 4.181/ <0.001* | ||
| 9 month | 19.36 (2.08) | 17.05 (2.96) | 4.134/ <0.001* | ||
| Fa/ p | 53.237/ <0.001* | 0.464/ 0.708 | |||
| Meaningfulness | Baseline | 18.83 (4.62) | 18.88 (3.86) | -0.051/ 0.959 | 0.41 |
| 3 month | 23.19 (2.58) | 18.62 (3.26) | 7.127/ <0.001* | ||
| 6 month | 22.02 (2.6) | 18.05 (3.0) | 6.487/ <0.001* | ||
| 9 month | 21.93 (2.49) | 17.93 (3.23) | 6.358/ <0.001* | ||
| Fa/ p | 50.530/ <0.001* | 4.949/ 0.006 | |||
aRepeated measures analysis of variance, bIndependent-samples t-test
*** p < 0.05, ** p < 0.01, * p < 0.001
Women who participated in SAFRAPP showed a statistically significant increase in their WBI total mean scores compared to the CG at the 3rd, 6th, and 9th months (p < 0.001). In within-group comparisons, the changes in WBI scores over time (3rd, 6th, and 9th months) were statistically significant compared to the baseline scores (p < 0.001) (Table 3). Thus, H4 was accepted.
Table 3.
Comparison of secondary outcomes scores in the intervention and control groups
| Secondary outcomes | Intervention (n = 38) | Control (n = 37) | tb / p | ||
|---|---|---|---|---|---|
| M (SD) | M (SD) | η² | |||
| EQ Index | Baseline | 0.81 (0.12) | 0.82 (0.10) | -0.356/ 0.722 | 0.19 |
| 3 month | 0.89 (0.07) | 0.82 (0.10) | 3.313/ <0.001* | ||
| 6 month | 0.89 (0.07) | 0.83 (0.10) | 3.029/ 0.003** | ||
| 9 month | 0.87 (0.09) | 0.82 (0.11) | 2.190/ 0.031*** | ||
| Fa/ p | 17.426/ <0.001* | 0.817/ 0.487 | |||
| EQ VAS | Baseline | 75.95 (12.89) | 74.05 (13.63) | 0.658/ 0.512 | 0.11 |
| 3 month | 83.33 (8.74) | 73.33 (13.73) | 3.981/ <0.001* | ||
| 6 month | 82.62 (9.39) | 73.33 (13.37) | 3.683/ <0.001* | ||
| 9 month | 79.29 (13.86) | 72.62 (14.15) | 2.181/ 0.032*** | ||
| Fa/ p | 9.107/ <0.001* | 1.519/ 0.213 | |||
| WBI | Baseline | 48.19 (22.07) | 48.86 (14.98) | -0.162/ 0.872 | 0.54 |
| 3 month | 72.86 (9.33) | 49.33 (14.37) | 8.897/ 0.872 | ||
| 6 month | 71.62 (10.48) | 49.62 (14.36) | 8.021/ <0.001* | ||
| 9 month | 70.86 (10.43) | 49.05 (14.14) | 8.046/ <0.001* | ||
| Fa/ p | 85.298/ <0.001* | 0.774/ 0.511 | |||
| Fear of fall | Baseline | 2.62 (0.91) | 2.69 (0.95) | -0.352/ 0.726 | 0.18 |
| 3 month | 3.26 (0.54) | 2.71 (1.02) | 3.073/ 0.003** | ||
| 6 month | 3.24 (0.66) | 2.69 (0.9) | 3.195/ 0.002** | ||
| 9 month | 2.88 (0.77) | 2.55 (0.99) | 1.718/ 0.090 | ||
| Fa/ p | 15.534/ <0.001* | 1.132/ 0.339 | |||
| Number of fall | Baseline | 0.29 (0.51) | 0.36 (0.48) | -0.659/ 0.512 | 0.04 |
| 3 month | 0.17 (0.38) | 0.29 (0.46) | -1.302/ 0.197 | ||
| 6 month | 0.17 (0.44) | 0.26 (0.45) | -0.989/ 0.325 | ||
| 9 month | 0.21 (0.47) | 0.31 (0.47) | -0.930/ 0.355 | ||
| Fa/ p | 3.371/ 0.057 | 0.655/ 0.581 | |||
| Number of admission to emergency | Baseline | 0.83 (1.29) | 0.71 (0.94) | 0.483/ 0.630 | 0.07 |
| 3 month | 0.64 (1.23) | 0.71 (0.71) | -0.327/ 0.745 | ||
| 6 month | 0.67 (1.22) | 0.76 (0.73) | -0.434/ 0.666 | ||
| 9 month | 0.74 (1.31) | 0.9 (0.91) | -0.679/ 0.499 | ||
| Fa/ p | 5.541/ <0.001* | 0.903/ 0.436 | |||
aRepeated measures analysis of variance, bIndependent-samples t-test
*** p < 0.05, ** p < 0.01, * p < 0.001
A statistically significant difference was found between the IG and CG in the EQ index score and the EQ VAS mean scores at the 3rd and 6th months (p < 0.01). The quality of life measured by the EQ-5D-3 L was higher in the IG than the CG. In within-group comparisons, the changes in the EQ index and EQ VAS mean scores over time were statistically significant compared to the baseline scores in the SAFRAPP group (p < 0.001) (Table 3). Thus, H5 was accepted.
The change in fear of falling scores between the IG and CG at the 3rd and 6th months was found to be significant (p < 0.05). No statistically significant difference was found in the mean number of falls between and within groups at the 3rd, 6th, and 9th months (p > 0.05). The change in the number of emergency visits over time (3rd, 6th, and 9th months) was statistically significant in the SAFRAPP group compared to baseline (F = 5.541, p = 0.001), while no significant difference was found compared to the CG (p > 0.05) (Table 3). Thus, H6, H7 and H8 were rejected.
Discussion
The SAFRAPP is characterized as a multi-component intervention consisting of health education, laughter yoga, and case management. The study findings demonstrated that SAFRAPP reduced frailty risk in women in the pre-frailty stage, prevented the transition to frailty, enhanced the sense of coherence, and improved quality of life and well-being.
In the study, nearly half of the pre-frail women aged 55 and over who participated in SAFRAPP transitioned to the robust stage at the 3rd and 6th months, with no progression to frailty. A study involving pre-frail individuals aged 50 and over found that after 12 weeks of exercise, cognitive training, and board game activities, 83.3% transitioned to the robust stage [42]. Another study involving individuals aged 80 and over found that after a 6-week intervention consisting of exercise, Mediterranean diet, telehealth, and medication adjustment, 14.1% of the experimental group transitioned to the robust stage by the 12th month [43]. A study by Serra-Prat et al. (2017) found that interventions such as nutrition assessment and physical activity have not significantly prevented frailty [44]. Interventions addressing both physical and psychological health dimensions may be more effective in preventing frailty [12, 15]. In this study, SAFRAPP included psychosocially focused interventions such as laughter yoga. Furthermore, it has been noted that frailty risk begins as early as the forties, and early interventions may be more effective in preventing frailty [3, 7]. Therefore, the multi-component interventions included in SAFRAPP are considered to have played a significant role in enabling nearly half of the women in the intervention group to transition to the robust stage and in reducing frailty risk.
In the study, the SOC scores of women in the both groups were at a moderate level before the intervention. Following SAFRAPP, SOC scores at the 3rd, 6th, and 9th months were found to be higher in the IG compared to the CG. Similarly, a study conducted in South Korea demonstrated that a salutogenic approach-based program was effective in enhancing the SOC of women living in nursing homes [17]. Another study found that women who participated in a stress management program showed a significant increase in SOC scores compared to the CG at 8 and 16 weeks after the program [45]. However, a recent study found no significant difference in SOC scores between groups following reminiscence therapy for women in nursing homes during the COVID-19 pandemic [18]. Additionally, no significant difference was found in SOC scores between groups after six months of endurance exercises conducted twice a week among physically active Swedish women aged 65–70 [16]. The SOC is a coping mechanism for stressors, promoting resilience by enabling individuals to perceive life as manageable and meaningful while effectively utilizing available resources [20]. In SAFRAPP, providing health education on stressors and resistance resources related to frailty, guiding on appropriate resources for frailty prevention within the case management, and implementing laughter yoga can contribute to the improvement of SOC among women.
This study demonstrated a significant improvement in the quality of life of women who participated in SAFRAPP. This finding is consistent with the results of some interventional studies conducted with pre-frail individuals [43, 46, 47]. Furthermore, the findings of our study showed a significant increase in well-being among women in the SAFRAPP group at the 3rd, 6th, and 9th months compared to the CG. This result aligns with the findings of a study in which a 12-week multi-component intervention (including nutritional supplementation, exercise, and cognitive training) was implemented [48]. On the other hand, an 8-week gardening therapy program, applied for 60 min per week to pre-frail individuals in a nursing home, was found to have no significant effect on improving well-being [49]. A 12-week intervention combining vitamin D supplementation and exercise in older women living in the community did not show any impact on mental well-being [50]. Studies in the literature have demonstrated the positive effects of laughter yoga on physical and psychosocial health [29, 30]. In this context, the 12-session laughter yoga program included in SAFRAPP might be contributed to the improvement of well-being among women aged 55 and over in this study.
In this study, SAFRAPP did not show a significant difference in reducing the number of falls compared to the CG. Similarly, a study investigating the effects of nutritional assessment and physical activity interventions on pre-frail older individuals living in the community found no significant reduction in the number of falls within the last three months [44]. Contrary to our findings, a home-based exercise program implemented over one year was found to reduce the number of falls [51]. The lack of a significant reduction in the number of falls, which was a secondary outcome of this study, may be related to the duration of SAFRAPP. Future studies aiming to reduce falls in frail or at-risk individuals are recommended to design longer-term interventions.
In this study, SAFRAPP did not show a significant difference in reducing the number of emergency visits compared to the CG. Similarly, a study conducted in a nursing home with individuals aged 70 and over found no significant reduction in emergency visits at the 12th month following a six-week, multi-component, moderate-intensity exercise program [52]. Conversely, a study examining the effectiveness of integrative care in frail COPD patients found a decrease in the number of emergency visits [53]. A systematic review and meta-analysis also indicated that there is insufficient evidence regarding interventions aimed at reducing or preventing hospital visits in pre-frail individuals, suggesting the need for further development of such interventions [15]. At this point, factors beyond frailty—such as advanced age, cardiovascular, gastrointestinal, and renal system diseases, as well as comorbidities—may also contribute to emergency visits [3, 9].
Limitations of the study
One of the limitations of the present study was the use of single-blinding and on self-reported data for both pretest and posttest measures. Another limitation of this study was that the inclusion of women with internet access in the study limit the generalizability of the findings.
Practical and policy implications of the study
Early detection and effective management of frailty are essential to maintaining or restoring healthy aging trajectories. Consistent with the WHO’s healthy aging framework, which emphasizes physical, cognitive, psychological, and social functioning as well as intrinsic capacity and environmental factors, SAFRAPP successfully addressed most of these domains [54]. In addition, building and maintaining a strong SOC is a key pathway to achieving healthy aging. The SAFRAPP presented a guide to improve SOC, well-being and quality of life among pre-frail women. Given its online format and implementation in natural community settings, SAFRAPP represents an accessible approach that can be integrated into routine public health practice. At the policy level, supporting evidence-based digital health programs such as SAFRAPP within national healthy aging strategies can enhance early frailty prevention efforts, improve health outcomes, and reduce healthcare costs in the long term.
Conclusions
It was found that nearly half of the women in SAFRAPP group transitioned from pre-frail to robust status at the 3rd, 6th, and 9th months. SAFRAPP showed a significant increase in women’s SOC, quality of life and well-being over time, whereas there was no significant change in reducing the number of falls and the number of emergency visits between the groups. According to the study’s findings, SAFRAPP can be utilized to prevent frailty and promote SOC in older women as a multicomponent approach. Future studies should assess SAFRAPP’s effectiveness in preventing frailty and enhancing the sense of coherence among diverse middle-aged and older adults across various settings. The findings of this study emphasize that the transition to frailty, which leads to negative health outcomes, can be prevented. This highlights its potential contribution to the United Nations Sustainable Development Goals, particularly Goal 3: Good Health and Well-being, which aims to ensure healthy lives and improve health outcomes by 2030.
Acknowledgements
The authors thank to the manager of the municipality’s institutions for their collaboration and supports.
Author contributions
MAY: Conceptualization, Methodology, Investigation, Data curation, Resources, Formal analysis, Project administration, Writing – original draft, Writing – review & editingSS: Methodology, Data curation, Resources, Formal analysis, Writing – original draft, Writing – review & editing.
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Data availability
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Declarations
Ethics approval and consent to participate
This study was conducted in accordance with the Declaration of Helsinki Ethical Principles. Ethical approval (IRB Number: 2019/62) and institutional permission (dated February 2, 2020) were obtained from the Ethics Committee for the Social Sciences and Humanities and the Center of Vocational Institutions in a municipality in Türkiye. Participants provided online informed consent before randomization and baseline data collection.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
References
- 1.World Health Organization. WHO Clinical Consortium on Healthy Ageing. 2017. Retrieved from https://iris.who.int/bitstream/handle/10665/272437/WHO-FWC-ALC-17.2-eng.pdf?sequence=1. Accessed 1 Mar 2025.
- 2.Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, et al. Frailty in older adults: evidence for a phenotype. Journals Gerontol Ser A: Biol Sci Med Sci. 2001;56(3):M146–57. [DOI] [PubMed] [Google Scholar]
- 3.Rohrmann S. Epidemiology of frailty in older people. Adv Exp Med Biol. 2020;1216:21–7. [DOI] [PubMed] [Google Scholar]
- 4.World Health Organization. Ageing and health. 2024. Retrieved from https://www.who.int/news-room/fact-sheets/detail/ageing-and-health. Accessed 1 Mar 2025.
- 5.Cunha AIL, Veronese N, de Melo Borges S, Ricci NA. Frailty as a predictor of adverse outcomes in hospitalized older adults: A systematic review and meta-analysis. Ageing Res Rev. 2019;56:100960. [DOI] [PubMed] [Google Scholar]
- 6.Keeble E, Roberts HC, Williams CD, Van Oppen J, Conroy SP. Outcomes of hospital admissions among frail older people: a 2-year cohort study. Br J Gen Pract. 2019;69(685):e555–60. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Travers J, Romero-Ortuno R, Bailey J, Cooney MT. Delaying and reversing frailty: a systematic review of primary care interventions. Br J Gen Pract. 2019;69(678):e61–9. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Ofori-Asenso R, Chin KL, Mazidi M, Zomer E, Ilomaki J, Zullo AR, et al. Global incidence of frailty and prefrailty among Community-Dwelling older adults: A systematic review and Meta-analysis. JAMA Netw Open. 2019;2(8):e198398. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Turkish Society of Physical Medicine and Rehabilitation, Group GRW, Eyigor S, Kutsal YG, Duran E, Huner B, Paker N, et al. Frailty prevalence and related factors in the older adult—FrailTURK project. AGE. 2015;37(3):50. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Salem BE, Ma-Pham J, Chen S, Brecht ML, Antonio AL, Ames M. Impact of a Community-Based frailty intervention among Middle-Aged and older prefrail and frail homeless women: A pilot randomized controlled trial. Community Ment Health J. 2017;53(6):688–94. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Albornos-Muñoz L, Blanco-Blanco J, Cidoncha-Moreno MÁ, Abad-Corpa E, Rivera-Álvarez A, López-Pisa RM, et al. Efficacy of the Otago-Exercise-Programme to reduce falls in community-dwelling adults aged 65–80 when delivered as group or individual training: Non-inferiority-clinical-trial. BMC Nurs. 2024;23(1):705. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Dedeyne L, Deschodt M, Verschueren S, Tournoy J, Gielen E. Effects of multi-domain interventions in (pre)frail elderly on frailty, functional, and cognitive status: a systematic review. CIA. 2017;12:873–96. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Pilotto A, Custodero C, Maggi S, Polidori MC, Veronese N, Ferrucci L. A multidimensional approach to frailty in older people. Ageing Res Rev. 2020;60:101047. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Song MS, Boo S. Effects of a nurse-led multicomponent intervention for frail older adults living alone in a community: a quasi-experimental study. BMC Nurs. 2022;21(1):20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Frost R, Belk C, Jovicic A, Ricciardi F, Kharicha K, Gardner B, et al. Health promotion interventions for community-dwelling older people with mild or pre-frailty: a systematic review and meta-analysis. BMC Geriatr. 2017;17(1):157. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16.Ericson H, Skoog T, Johansson M, Wåhlin-Larsson B. Resistance training is linked to heightened positive motivational state and lower negative affect among healthy women aged 65–70. J Women Aging. 2018;30(5):366–81. [DOI] [PubMed] [Google Scholar]
- 17.Oh HJ, Gang M, Kim MS. Development and effect of a salutogenic program for rural elderly women on depression and suicidal ideation. Issues Ment Health Nurs. 2021;42(9):855–61. [DOI] [PubMed] [Google Scholar]
- 18.Sales A, Pinazo-Hernandis S, Martinez D. Effects of a reminiscence program on meaning of life, sense of coherence and coping in older women living in nursing homes during COVID-19. Healthcare. 2022;10(2):188. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Antonovsky A. The salutogenic model as a theory to guide health promotion. Health Promot Int. 1996;11(1):11–8. [Google Scholar]
- 20.Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindström B, et al. editors. The Handbook of Salutogenesis [Internet]. Cham: Springer International Publishing; 2017 [cited 2025 Mar 11]. Available from: http://link.springer.com/10.1007/978-3-319-04600-6 [PubMed]
- 21.Moons P, Apers S, Kovacs AH, Thomet C, Budts W, Enomoto J, et al. Sense of coherence in adults with congenital heart disease in 15 countries: patient characteristics, cultural dimensions and quality of life. Eur J Cardiovasc Nurs. 2021;20(1):48–55. [DOI] [PubMed] [Google Scholar]
- 22.Taha SM, El-Sayed MM, Khedr MA, El-Ashry AM, Abdelraof AI, Sonbol HM, et al. Unraveling the power of sense of coherence: a key predictor of symptom severity among depressive disorders clients. BMC Nurs. 2025;24(1):21. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Yas MA, Secginli S. Salutogenic Model-Based frailty prevention program for Pre-Frail women aged 55 years and over (SAFRAPP): A study protocol for a randomized controlled trial. Res Theory Nurs Pract. 2022;36(2):215–32. [DOI] [PubMed] [Google Scholar]
- 24.Gordon SJ, Baker N, Kidd M, Maeder A, Grimmer KA. Pre-frailty factors in community-dwelling 40–75 year olds: opportunities for successful ageing. BMC Geriatr. 2020;20(1):96. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25.Arik G, Varan HD, Yavuz BB, et al. Validation of Katz index of independence in activities of daily living in Turkish older adults. Arch Gerontol Geriatr. 2015;61(3):344–50. [DOI] [PubMed] [Google Scholar]
- 26.Ng TP, Feng L, Nyunt MSZ, Feng L, Niti M, Tan BY, et al. Nutritional, physical, cognitive, and combination interventions and frailty reversal among older adults: A randomized controlled trial. Am J Med. 2015;128(11):1225–e12361. [DOI] [PubMed] [Google Scholar]
- 27.Saum KU, Schöttker B, Meid AD, et al. Is polypharmacy associated with frailty in older people?? Results from the ESTHER cohort study. J Am Geriatr Soc. 2017;65(2):e27–32. [DOI] [PubMed] [Google Scholar]
- 28.Kataria M. Laugh for no reason. 2. ed., new rev. ed. Mumbai: Madhuri International; 2002. [Google Scholar]
- 29.Erkin Ö, Kocaçal E. The impact of laughter yoga as a NIC on health parameters in nurses and nursing students: a systematic review. BMC Complement Med Ther. 2024;24(1):378. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 30.Yas MA, Incesu O. The effect of laughter yoga on well-being, perceived stress, and academic self‐efficacy in nursing students: A randomized controlled trial. Appl Psych Health Well. 2025;17(1):e12610. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 31.Martin KS. The Omaha system: a key to practice, documentation, and information management. Reprinted second edition. Omaha, NE: Health Connections; 2009. [Google Scholar]
- 32.Uymaz PE, Nahcivan NO. Evaluation of a nurse-led fall prevention education program in Turkish nursing home residents. Educ Gerontol. 2016;42(5):299–309.
- 33.Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012;16(7):601–8. [DOI] [PMC free article] [PubMed]
- 34.Hymabaccus BAB, Dogrul RT, Balci C, Ozsurekci C, Caliskan H, Karabulut E, et al. An effective and practical tool to assess physical frailty in older adults: Turkish validation of the FRAIL scale. Marmara Med J. 2023;36(2):149–56. [Google Scholar]
- 35.Scherler RH, Lajunen T. A comparison of Finnish and Turkish university students on the short form of the sense of coherence scale. 5th Congress of European Psychology; 1997 July 6–11; Dublin, Ireland.
- 36.Oztekin C, Tezer E. The role of sense of coherence and physical activity in positive and negative affect of Turkish adolescents. Adolescence. 2009;44(174):421–32. [PubMed] [Google Scholar]
- 37.Uzdıl N, Bayrak M, Özgüç S, Başkaya E. The mediating effect of work-family life balance on the relationship between the sense of coherence and job satisfaction in nurses. Arch Psychiatr Nurs. 2023;46:33–9. [DOI] [PubMed] [Google Scholar]
- 38.Yalnizca-Yildirim S. After Kahramanmaras earthquake in turkey: perceived social support, sense of coherence and state hope. Curr Psychol. 2024;43(45):34937–46. [Google Scholar]
- 39.Eser E, Çevik C, Baydur H, Güneş S, Esgin TA, Öztekin ÇS, et al. Reliability and validity of the Turkish version of the WHO-5, in adults and older adults for its use in primary care settings. Prim Health Care Res Dev. 2019;20:e100. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 40.EuroQol Research Foundation. EQ-5D-3L User Guide. 2018. Retrieved from https://euroqol.org/publications/user-guides. Accessed 1 Mar 2025.
- 41.Kahyaoglu Sut H, Unsar S, Is. EQ-5D a valid quality of life instrument in patients with acute coronary syndrome? Anadolu Kardiyol Derg. 2011;11(2):156–62. [DOI] [PubMed] [Google Scholar]
- 42.Yu R, Tong C, Ho F, Woo J. Effects of a multicomponent frailty prevention program in prefrail Community-Dwelling older persons: A randomized controlled trial. J Am Med Dir Assoc. 2020;21(2):e2941–29410. [DOI] [PubMed] [Google Scholar]
- 43.Gené Huguet L, Navarro González M, Kostov B, Ortega Carmona M, Colungo Francia C, Carpallo Nieto M, et al. Pre frail 80: multifactorial intervention to prevent progression of Pre-Frailty to frailty in the elderly. J Nutr Health Aging. 2018;22(10):1266–74. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 44.Serra-Prat M, Sist X, Domenich R, Jurado L, Saiz A, Roces A, et al. Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial. Age Ageing. 2017;46(3):401–40. [DOI] [PubMed] [Google Scholar]
- 45.Haraldsson K, Fridlund B, Baigi A, Marklund B. The self-reported health condition of women after their participation in a stress management programme: a pilot study. Health Soc Care Community. 2005;13(3):224–30. [DOI] [PubMed] [Google Scholar]
- 46.Barrachina-Igual J, Martínez-Arnau FM, Pérez-Ros P, Flor-Rufino C, Sanz-Requena R, Pablos A. Effectiveness of the PROMUFRA program in pre-frail, community-dwelling older people: A randomized controlled trial. Geriatr Nurs. 2021;42(2):582–91. [DOI] [PubMed] [Google Scholar]
- 47.Otones P, García E, Sanz T, Pedraz A. A physical activity program versus usual care in the management of quality of life for pre-frail older adults with chronic pain: randomized controlled trial. BMC Geriatr. 2020;20(1):396. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 48.Ng TP, Nyunt MSZ, Feng L, Feng L, Niti M, Tan BY, et al. Multi-domains lifestyle interventions reduces depressive symptoms among frail and pre-frail older persons: randomized controlled trial. J Nutr Health Aging. 2017;21(8):918–26. [DOI] [PubMed] [Google Scholar]
- 49.Lai CKY, Kwan RYC, Lo SKL, Fung CYY, Lau JKH, Tse MMY. Effects of horticulture on frail and prefrail nursing home residents: A randomized controlled trial. J Am Med Dir Assoc. 2018;19(8):696–702. [DOI] [PubMed] [Google Scholar]
- 50.Patil R, Karinkanta S, Tokola K, Kannus P, Sievänen H, Uusi-Rasi K. Effects of vitamin D and exercise on the wellbeing of older Community-Dwelling women: A randomized controlled trial. Gerontology. 2016;62(4):401–8. [DOI] [PubMed] [Google Scholar]
- 51.Pérez-Ros P, Vila-Candel R, Martínez-Arnau FM. A home-based exercise program focused on proprioception to reduce falls in frail and pre-frail community-dwelling older adults. Geriatr Nurs. 2020;41(4):436–44. [DOI] [PubMed] [Google Scholar]
- 52.Arrieta H, Rezola-Pardo C, Gil SM, Virgala J, Iturburu M, Antón I, et al. Effects of multicomponent exercise on frailty in Long-Term nursing homes: A randomized controlled trial. J Am Geriatr Soc. 2019;67(6):1145–51. [DOI] [PubMed] [Google Scholar]
- 53.Hernández C, Alonso A, Garcia-Aymerich J, Serra I, Marti D, Rodriguez-Roisin R, et al. Effectiveness of community-based integrated care in frail COPD patients: a randomised controlled trial. Npj Prim Care Resp Med. 2015;25(1):15022. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 54.World Health Organization. Decade of healthy ageing: baseline report. Retrieved from https://www.who.int/publications/i/item/9789240017900. Accessed 21 Aug 2025.
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.