Study protocol for a randomized controlled trial: Effect of an everyday cognition training program on cognitive function, emotional state, frailty and functioning in older adults without cognitive impairment.

BACKGROUND: Ageing entails changes in complex cognitive functions that lead to a decrease in autonomy and quality of life. Everyday cognition is the ability to solve cognitively complex problems in the everyday world, enabling instrumental activities of life. Benefits have been found in studies using everyday cognition-based assessment and intervention, as the results predict improvements in everyday performance, not just in specific cognitive functions. A study protocol is presented based on assessment and training in everyday cognition versus traditional cognitive stimulation for the improvement of functionality, emotional state, frailty and cognitive function. METHODS: A parallel randomised controlled clinical trial with two arms will be conducted. It will be carried out by the University of Salamanca (Spain) in eleven centres and associations for the elderly of the City Council of Salamanca. People aged 60 years or older without cognitive impairment will be recruited. Participants will be randomly distributed into two groups: the experimental group will undergo a training programme in everyday cognition and the control group a programme of traditional cognitive stimulation, completing 25 sessions over 7 months. All participants will be assessed at the beginning and at the end of the intervention, where socio-demographic data and the following scales will be collected: The Medical Outcomes Study (MOS), Questionnaire ARMS-e, Everyday Cognition Test (PECC), Scale Yesavage, Test Montreal Cognitive Assessment (MoCA), The Functional Independence Measure (FIM), Fragility Index and Lawton y Brody Scale. DISCUSSION: The present study aims to improve conventional clinical practice on cognitive function training by proposing a specific assessment and intervention of everyday cognition based on the importance of actual cognitive functioning during the resolution of complex tasks of daily life, giving priority to the improvement of autonomy. TRIAL REGISTRATION: ClinicalTrials.gov; ID: NCT05688163. Registered on: January 18, 2023.

Effect and usability of the use of twitter as a complementary teaching tool in different subjects of nursing studies: Educational intervention study.

BACKGROUND: Some social networks, such as Twitter (now known as X), have proven to be very useful for sharing and discussing multiple aspects related to the healthcare field. However, the use of Twitter as a method of communication and knowledge transfer to nursing students has been limited. OBJECTIVES: To evaluate the usability and effect of an educational intervention for monitoring additional content, through the social network Twitter, of various subjects of nursing studies (clinical nursing, community nursing, and nursing fundamentals). DESIGN: An exploratory experimental study was carried out through an educational intervention during the 2020-2021 and 2021-2022 academic years. SETTINGS: Faculty of Nursing at the University of Salamanca, Spain. Participants were 308 students. METHODS: Students used Twitter to receive tweets about news or links to subject-related content. They also completed a pre-post questionnaire. RESULTS: A high degree of visualization and interaction of the study's Twitter account stands out, mainly in the subject clinical nursing. In relation to usability, the participants stated that they strongly agreed with aspects such as "thinking that it was easy to use the account" (59.4 %) as well as "imagining that the majority of colleagues would learn very quickly to use said account" (46.5 %). Students who used the account at least once a day obtained higher scores on the post-study knowledge questionnaire than those who used it less than once a day (p < 0.05), or those who used it 2 or 3 times during the study (p = 0.010). CONCLUSIONS: The group of participants who used the Twitter account at least once a day stated that using the account was easy and that they would like to use it more frequently. Likewise, greater use of this tool was associated with a better score on a post-study knowledge questionnaire.

Analysis of the determinants of sleep quality in a Spanish population: a study protocol for a cross-sectional study.

INTRODUCTION: Sleep problems are a growing public health concern being related, among others, to an increased risk of cardiovascular diseases or worse cognitive functioning. In addition, they can affect aspects related to personal motivation and quality of life. However, very few studies have analysed the possible determinants of sleep quality in the adult population as a whole, establishing patterns based on these determinants.The objectives are to evaluate the determinants of sleep quality in a representative sample of the general adult population between 25 and 65 years old, and to establish patterns of sleep quality based on lifestyles, psychological factors, morbidities, sociodemographic variables, biological markers and other possible determinants. METHODS AND ANALYSIS: Descriptive observational cross-sectional study. The study population will include a representative sample of 500 people between 25 and 65 years old from the cities of Salamanca and Ávila (Spain) selected by random sampling stratified by age groups and sex. A 90-minute visit will be performed, during which sleep quality will be assessed. The variables collected will be: morbidity, lifestyles (physical activity, diet, toxic habits), psychological factors (depression, stress, occupational stress and anxiety), socioeconomic and work-related variables, habitability conditions of the habitual residence and rest area, screen time, relaxation techniques and melatonin as a biological marker related to sleep quality. DISCUSSION: With the results of this work, improved interventions for behaviour modification could be designed, as well as intervention and education programmes or other research aimed at improving sleep quality. ETHICS AND DISSEMINATION: This study has a favourable opinion from the Ethics Committee for Drug Research of the Health Areas of Salamanca and Ávila (CEim Code: PI 2021 07 815). The results of this study will be published in international impact journals of different specialties. TRIAL REGISTRATION NUMBER: NCT05324267.

Relationship of Different Anthropometric Indices with Vascular Ageing in an Adult Population without Cardiovascular Disease-EVA Study.

The objectives of this study were to analyse the capacity of different anthropometric indices to predict vascular ageing and this association in Spanish adult population without cardiovascular disease. A total of 501 individuals without cardiovascular disease residing in the capital of Salamanca (Spain) were selected (mean age: 55.9 years, 50.3% women), through stratified random sampling by age and sex. Starting from anthropometric measurements such as weight, height, and waist circumference, hip circumference, or biochemical parameters, we could estimate different indices that reflected general obesity, abdominal obesity, and body fat distribution. Arterial stiffness was evaluated by measuring carotid-femoral pulse wave velocity (cf-PWV) using a SphygmoCor® device. Vascular ageing was defined in three steps: Step 1: the participants with vascular injury were classified as early vascular ageing (EVA); Step 2: classification of the participants using the 10 and 90 percentiles of cf-PWV in the study population by age and sex in EVA, healthy vascular ageing (HVA) and normal vascular ageing (NVA); Step 3: re-classification of participants with arterial hypertension or type 2 diabetes mellitus included in HVA as NVA. The total prevalence of HVA and EVA was 8.4% and 21.4%, respectively. All the analysed anthropometric indices, except waist/hip ratio (WHpR), were associated with vascular ageing. Thus, as the values of the different anthropometric indices increase, the probability of being classified with NVA and as EVA increases. The capacity of the anthropometric indices to identify people with HVA showed values of area under the curve (AUC) ≥ 0.60. The capacity to identify people with EVA, in total, showed values of AUC between 0.55 and 0.60. In conclusion, as the values of the anthropometric indices increased, the probability that the subjects presented EVA increased. However, the relationship of the new anthropometric indices with vascular ageing was not stronger than that of traditional parameters. Therefore, BMI and WC can be considered to be the most useful indices in clinical practice to identify people with vascular ageing in the general population.

Reference values of central blood pressure and central haemodynamic parameters and their relationship with cardiovascular risk factors in a Spanish population: early vascular ageing study.

OBJECTIVES: Central blood pressure (BP) predicts mortality independent of office brachial BP. The aim was to describe reference values for central blood pressure and pulsatile hemodynamic parameters, and their relationship with cardiovascular risk factors in an adult Spanish population without cardiovascular disease. METHODS: Cross-sectional study. We included 501 participants stratified by age and sex by random sampling, with a mean age of 56 years (50.3% women). The SphygmoCor System device's pulse wave analysis software was used to perform the measurements. RESULTS: The following values were obtained: central blood pressure median (109/76 mmHg), central pulse pressure (33 mmHg), pulse pressure amplification (8.5 mmHg), ejection duration (130 ms) and subendocardial viability ratio (163%). All parameters were greater in men, except heart rate and ejection duration. In the logistic regression analysis, controlled for age, sex and taking antihypertensive drugs, being hypertensive was associated with cSBP (OR = 1.265), cDBP (OR = 1.307), cPP (OR = 1.067), pulse wave amplification (OR = 1.034) and SEVR (OR = 0.982); being diabetic was associated with SEVR (OR = 0.982); being obese was associated with cSBP (OR = 1.028) and cDBP (OR = 1.058) and being a smoker was associated with ejection duration (OR = 0.980) and SEVR (OR = 0.984). CONCLUSION: This study provides reference values for central blood pressure and parameters derived from the pulse wave analysis in a random sample of the Spanish population. The only risk factor that is not associated with any of the parameters analysed is dyslipidaemia. TRIAL REGISTRATION NUMBER: https://clinicaltrials.gov/ct2/show/NCT02623894.

Association between measurements of arterial stiffness and target organ damage in a general Spanish population.

INTRODUCTION: Little is known about the relationship between arterial stiffness and cardiovascular target organ damage (TOD) in the general population. The aim was to analyse the relationship between different measurements of arterial stiffness and TOD, in a general Spanish population without a history of cardiovascular event. MATERIALS AND METHODS: Transversal descriptive study. Through stratified random sampling, a total of 501 individuals were included. Carotid-femoral pulse wave velocity (cf-PWV) was measured using a SphygmoCor System®, the cardio-ankle vascular index (CAVI) was determined with aVasera VS-1500® and brachial-ankle pulse wave velocity (ba-PWV)was calculated through a validated equation. RESULTS: The average age was 55.84 ± 14.26.The percentage of vascular TOD, left ventricular hypertrophy (LVH) and renal TOD was higher in men (p < .001). A positive correlation was obtained between carotid intima-media thickness (c-IMT) and the measurements of vascular function. In the model 1 of the logistic regression analysis, cf-PWV was associated with vascular TOD (OR = 1.15, p = .040), ba-PWV was associated with vascular TOD (OR = 1.20, p = .010) and LVH (OR = 1.12, p = .047). CONCLUSIONS: The different measurements of arterial stiffness are highly associated with each other. Moreover, cf-PWV and ba-PWV were associated with vascular TOD, and ba-PWV with LVH, although they disappear when adjusting for cardiovascular risk factors. Key Messages There is a strong correlation between the different measurements of vascular structure and function. Carotid-femoral and brachial-ankle pulse wave velocity were positively associated with vascular target organ damage, the latter was also positively associated with left ventricular hypertrophy. This associations disappear when adjusting for cardiovascular risk factors.

Effect of an intensive intervention on the increase of physical activity and the decrease of sedentary lifestyle in inactive postmenopausal.

BACKGROUND: During the transition to menopause, women experience different psychological, hormonal, and physical alterations that can affect their health. Physical activity is considered an important strategy in the prevention and control of such changes. AIM: To evaluate the short-term effect of an intensive intervention, based on a combined exercise programme using a Smartband, on the increase of physical activity and the decrease of sedentary lifestyle in postmenopausal and inactive women. DESIGN: Randomized clinical trial with two parallel groups. METHODS: In total, 100 postmenopausal and inactive women aged 45-70 years will be randomized to a control group or an intervention group. Both groups will be given a standardized advice about physical activity. The intervention group will carry out a supervised 12-week programme of aerobic and muscle strengthening exercise; moreover, the women in this group will receive a Smartband to assist them in the intervention. The main result will be the increase of physical activity and the decrease of sedentary lifestyle, measured with an accelerometer for 1 week. This programme will be conducted by a nurse and a physiotherapist of the health centre. The study was approved by the Drug Research Ethics Committee of the Salamanca Health Service on 15 February 2019. The project was funded by the Autonomous Government of Castile and Leon and by the Carlos III Health Institute. DISCUSSION: Physical activity is an important strategy to consider when addressing the changes caused by menopause, although the current evidence shows that further studies should be carried out with longer intervention periods and new technologies. IMPACT: This study will allow determining the effectiveness of the intensive intervention based on a combined programme of physical activity using a Smartband in postmenopausal and inactive women. TRIALS REGISTRATION: ClinicalTrials.gov with identifying code NCT03872258.

Relationship of healthy vascular aging with lifestyle and metabolic syndrome in the general Spanish population. The EVA study.

INTRODUCTION AND OBJECTIVES: Our objective was to study the relationship of healthy vascular aging (HVA) with lifestyle and the components of metabolic syndrome. We also analyzed the differences between chronological age and heart age (HA) and vascular age (VA) in the Spanish adult population without cardiovascular disease. METHODS: This descriptive cross-sectional study selected 501 individuals without cardiovascular disease (mean age, 55.9 years; 50.3% women) via random sampling stratified by age and sex. HA was estimated with the Framingham equation, whereas VA was estimated with the VaSera VS-1500 device. HVA was defined as a <5-year difference between the chronological age and the HA or VA and the absence of a vascular lesion, hypertension, and diabetes mellitus. RESULTS: Compared with the chronological age, the mean HA and VA were 2.98±10.13 and 3.08±10.15 years lower, respectively. Smoking (OR, 0.23), blood pressure ≥ 130/85mmHg (OR, 0.11), altered baseline blood glucose (OR, 0.45), abdominal obesity (OR, 0.58), triglycerides ≥ 150mg/dL (OR, 0.17), and metabolic syndrome (OR, 0.13) decreased the probability of HVA estimated by HA; an active lifestyle (OR, 1.84) and elevated high-density lipoprotein-cholesterol (OR, 3.26) increased the probability of HVA estimated by HA. Smoking (OR, 0.45), blood pressure ≥ 130/85mmHg (OR, 0.26), altered baseline blood glucose (OR, 0.42), and metabolic syndrome (OR, 0.40) decreased the probability of HVA estimated by VA; abdominal obesity (OR, 1.81) had the opposite effect. CONCLUSIONS: HA and VA were 3 years lower than the chronological age. HA was associated with tobacco consumption, physical activity, and the components of metabolic syndrome. Meanwhile, VA was associated with tobacco consumption, blood pressure, waist circumference, and altered baseline glycemia. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Identifier: NCT02623894.

Prevalence of coronary atherosclerosis and reclassification of cardiovascular risk in Spanish population by coronary computed tomography angiography: EVA study.

BACKGROUND: A more complete assessment of coronary artery disease (CAD) can be performed by coronary computed tomography angiography (CCTA). The aim was to assess the prevalence, distribution and characteristics of coronary artery disease (CAD) and the reclassification of cardiovascular risk by CCTA in an asymptomatic Spanish population. DESIGN: We included, in a cross-sectional study, 501 random subjects from asymptomatic population, aged 35 and 75. Risk factors, target organ damage and cardiovascular risk were assessed. CCTA was offered to measure the coronary artery calcium score(CACS), segment involvement score(SIS) and segment stenosis score(SSS). The offer was accepted by 220 subjects (44%), with a mean age of 58 ± 14 years, 56% of them male. RESULTS: The mean CACS was 119.6 ± 381.7 (median (IQR) (0 (0-61.55))), with higher scores in males (191.9 ± 493.1) than females (26.1 ± 73.3; P < .01). CCTA revealed coronary atherosclerosis in 89 cases, 40% (CI95%:34%-46%) in global, 51% in male and 25% in female, of which 13 had obstructive lesions (5.9%). Mean SIS was 1.5 ± 2.5 and SSS 1.2 ± 3.1. When the CACS was included in the CAD risk scale, there was a reclassification of 24%, and when using the SIS percentile, it was 38%, with a 9% increase in risk in both cases. CONCLUSIONS: The prevalence of CAD in asymptomatic Spanish population was 40%, with greater proportion among males. The incorporation of CACS and SIS in the assessment of cardiovascular risk allows reclassifying subjects who are at low or moderate risk and thus identify those with high cardiovascular risk and also the other way.

Vascular aging and its relationship with lifestyles and other risk factors in the general Spanish population: Early Vascular Ageing Study.

OBJECTIVES: To describe the prevalence of healthy vascular aging (HVA), normal vascular aging and early vascular aging (EVA) in a sample of Spanish population without cardiovascular disease. The relationship of vascular aging with lifestyle, cardiovascular risk factors, psychological and inflammatory risk factors is also analyzed. METHODS: A total of 501 participants were recruited (49.70% men, aged 55.90 ±â€Š14.24 years) by random sampling. Vascular aging was defined in three steps: Step 1: participants with vascular damage in carotid arteries or peripheral artery disease were classified as EVA. Step 2: with the percentiles of carotid-to-femoral pulse wave velocity (cfPWV) we used three criteria, first, the 10th and 90th cfPWV percentiles of the population studied by age and sex; second, the 10th and 90th percentiles of the European population reference values and third, the 25th and 75th cfPWV percentiles of the population studied by age and sex. Step 3: participants with hypertension or type 2 diabetes mellitus included in HVA were reclassified as normal vascular aging. Arterial stiffness was assessed with cfPWV using a Sphygmocor device. Physical activity was measured with an accelerometer. Psychological factors, lifestyle and other clinical information were obtained by standard questionnaire. RESULTS: The global prevalence of HVA was 8 and 14% (men 8 and 10%, women 9 and 18%), and 22 and 18% (men 26 and 23%, women 17 and 12%) for EVA, using criteria a and b, respectively. In the logistic regression analysis, vascular aging maintains positive associations with more sedentary time [odds ratio (OR) = 2.37 and 4.51], having triglycerides above 150 mg/dl (OR = 6.55 and 4.06), abdominal obesity (OR = 2.73 and 2.90), increased uric acid (OR = 4.63 and 2.98) and insulin resistance index homeostatic model assessment (OR = 4.05 and 6.78), and a negative association with less physical activity (OR = 0.29 and 0.28) using criteria a and b, respectively. CONCLUSION: One in 10 has HVA and one in five EVA. The prevalence of EVA is higher in men. Study results suggest that preventive strategies aimed at increasing physical activity, reducing sedentary time and decreasing obesity and insulin resistance improve vascular aging.

Adherence to the Mediterranean Diet in Spanish Population and Its Relationship with Early Vascular Aging according to Sex and Age: EVA Study.

The objective of this study is to analyze the influence of adherence to the Mediterranean diet (MDA) and its components on early vascular aging (EVA) in a Spanish population sample free of cardiovascular disease and to analyze the differences by sex. METHODS: We recruited 501 individuals aged 35-75 without cardiovascular disease by random sampling (55.90 ± 14.24 years, 49.70% men). EVA was defined in two steps: Step 1: subjects with vascular damage in carotid arteries or peripheral artery disease were classified as EVA. Step 2: subjects at the percentile of the combined Vascular Aging Index (VAI) were classified; ≥ p90 was considered EVA and < p90 was considered normal vascular aging (NVA), estimated using the following formula (VAI = (log (1.09) × 10 cIMT + log (1.14) cfPWV) × 39.1 + 4.76 by age and sex. Carotid-femoral pulse wave velocity (cfPWV) was measured by SphigmoCor System® and carotid intima-media thickness by Sonosite Micromax® ultrasound and classified thus: values ≥ Percentile 90 were considered EVA and those < Percentile 90 as NVA, with population percentiles analyzed. The principal result variable was assessed using the 14-item MEDAS questionnaire, developed and validated by the PREDIMED group, comprising 12 questions about the frequency of food consumption and two questions regarding the Spanish population's typical eating habits. RESULTS: MDA was observed by 25% (17% men and 34% women). EVA was present in 17% (29% men and 4% women). The adjusted logistic regression models showed that an increase in MDA decreases the probability of EVA in the global analysis (OR = 0.36; 95% CI: 0.16-0.82). In the analysis by sex, this association was only seen in men (OR = 0.33; 95% CI: 0.12-0.86), but not in women (OR = 0.31; 95% CI: 0.04-2.50). CONCLUSION: The results of this study suggest that a greater adherence to the Mediterranean diet decreases the probability of presenting EVA. In the analysis by sex, this association applies only to men.

Multivariate Analysis of Influence of Vitamin Intake on Vascular Function Parameters by Sex in the General Spanish Population: EVA Study.

The influence of vitamin intake on vascular function parameters in the Spanish general population has not been studied. The main objective of this study is to analyze the influence of vitamin intake on vascular function and as a secondary objective the adequacy of vitamin intake in a sample of the Spanish population without previous cardiovascular disease and analyze the differences according to sex. Methods: We included 501 individuals obtained by simple random sampling with replacement (reference population 43,946). The average age was 55.90 ± 14.24 years, 49.70% men. Participants recorded the intake of vitamins using the EVIDENT app, previously validated, during a period of 3 days. Vascular function was assessed by measuring carotid-femoral pulse wave velocity (cfPWV) with the SphygmoCor device, cardio-ankle vascular index (CAVI) with the VaSera device and brachial-ankle pulse wave velocity (baPWV) by using a validated equation. Results: The vitamins with the least adequate intake was vitamin D, less than 5%, and vitamin B9, less than 35%. Vitamins with an adequate intake percentage, close to 100%, were B12 and B6. The multiple regression analysis showed a negative association between cfPWV and vitamin B2 in both sexes, and a positive one with retinol in men and B3 in women. baPWV was negatively associated with vitamins B1 and B12 in women and B9 in men, while being positively linked with B6 in men. CAVI presented a negative association with vitamin D in women. The results were similar in the canonical correspondence analysis. In conclusion, the results of this study suggest that the influence of vitamins on vascular function is not homogeneous and varies according to the parameter analyzed. Thus, in men, vitamins B2 and retinol were associated with cfPWV and vitamins B6 and B9 with baPWV. In women, vitamins B2 and B3 were related cfPWV, vitamins B1 and B12 with cfPWV and vitamin D with CAVI.

Postprandial effects of breakfast glycaemic index on cognitive performance among young, healthy adults: A crossover clinical trial.

Objective: To evaluate the postprandial effects of high and low glycaemic index (GI) breakfasts on cognitive performance in young, healthy adults.Methods: A crossover clinical trial including 40 young, healthy adults (aged 20-40 years, 50% females) recruited from primary healthcare centres in Salamanca, Spain. Verbal memory, phonological fluency, attention, and executive functions were examined 0, 60, and 120 minutes after consuming a low GI (LGI), high GI (HGI), or water breakfast. Every subject tried each breakfast variant, in a randomized order, separated by a washout period of 7 days, for a total of 3 weeks.Results: A significant interaction between the type of breakfast consumed and immediate verbal memory was identified (P<.05). We observed a trend towards better performance in verbal memory (delayed and immediate), attention, and phonological fluency following an LGI breakfast.Discussion: Cognitive performance during the postprandial phase in young, healthy adults was minimally affected by the GI of breakfast. The potential for breakfast's GI modulation to improve short- and long-term cognitive functioning requires further research.

Reclassification by applying the Framingham equation 30 years to subjects with intermediate cardiovascular risk. MARK study / Reclasificación utilizando la ecuación de Framingham a 30 años a sujetos con riesgo cardiovascular intermedio. Estudio MARK

Background and objective: The estimation of cardiovascular risk (CVR) with scores at 30 years old has a special interest in reclassifying in a suitable way <60 year subjects with intermediate CVR. This study analyzes what percentage of patients with intermediate CVR included in the MARK study is reclassified by applying the 30-year Framingham score (FS30). It also analyzes the degree of agreement between the two equations to classify high risk subjects. Patients and methods: Cross-sectional study of 966 subjects included in the MARK study. The CVR was calculated with the two versions of the FS30 (based on lipids and body mass index) for "hard" cardiovascular events in subjects with intermediate CVR. Results: The 59% and 61% of the subjects with intermediate CVR would be classified as if they had high CVR to undergo a hard event if we used the FS30 in both versions. 70% of men and 35% of women would be classified as high CVR (p<0.01). The agreement percentage, measured with the Kappa index, between the equations FS30L and FS30BMI to classify the high-risk subjects was 67.9% (in men 67.4% and in women 68.7%). Conclusions: In subjects with intermediate CVR the FS30 reclassifies more than the half as high RCV, 2 out of 3 men and 1 out of 3 women

Antecedentes y objetivo: La estimación del riesgo cardiovascular (RCV) con ecuaciones a 30 años tienen un interés especial para reclasificar de manera adecuada los sujetos de 60 años con RCV intermedio. Este estudio analiza qué porcentaje de pacientes con RCV intermedio incluido en el estudio MARK se reclasifica aplicando la puntuación de Framingham a 30 años (FS30) y grado de concordancia entre las 2 ecuaciones para clasificar a los sujetos de riesgo alto. Pacientes y métodos: Estudio transversal de 966 sujetos incluidos en el estudio MARK. El RCV se calculó con las 2 versiones del FS30 (basado en los lípidos y el índice de masa corporal) para eventos cardiovasculares «duros» en sujetos con RCV intermedio. Resultados: El 59 y el 61% de los sujetos con RCV intermedio se clasificarían como si tuvieran un RCV alto para sufrir un evento difícil si utilizáramos el FS30 en ambas versiones. El 70% de los varones y el 35% de las mujeres se clasificarían como RCV alto (p<0,01). El porcentaje de concordancia, medido con el índice Kappa, entre las ecuaciones FS30L y FS30BMI para clasificar a los sujetos de alto riesgo fue del 67,9% (en varones 67,4% y en mujeres 68,7%). Conclusiones: En sujetos con RCV intermedio, el FS30 reclasifica más de la mitad como RCV alto, 2 de cada 3 varones y una de cada 3 mujeres

Reclassification by applying the Framingham equation 30 years to subjects with intermediate cardiovascular risk. MARK study.

BACKGROUND AND OBJECTIVE: The estimation of cardiovascular risk (CVR) with scores at 30 years old has a special interest in reclassifying in a suitable way <60 year subjects with intermediate CVR. This study analyzes what percentage of patients with intermediate CVR included in the MARK study is reclassified by applying the 30-year Framingham score (FS30). It also analyzes the degree of agreement between the two equations to classify high risk subjects. PATIENTS AND METHODS: Cross-sectional study of 966 subjects included in the MARK study. The CVR was calculated with the two versions of the FS30 (based on lipids and body mass index) for "hard" cardiovascular events in subjects with intermediate CVR. RESULTS: The 59% and 61% of the subjects with intermediate CVR would be classified as if they had high CVR to undergo a hard event if we used the FS30 in both versions. 70% of men and 35% of women would be classified as high CVR (p<0.01). The agreement percentage, measured with the Kappa index, between the equations FS30L and FS30BMI to classify the high-risk subjects was 67.9% (in men 67.4% and in women 68.7%). CONCLUSIONS: In subjects with intermediate CVR the FS30 reclassifies more than the half as high RCV, 2 out of 3 men and 1 out of 3 women.

Acute effect of healthy walking on arterial stiffness in patients with type 2 diabetes and differences by age and sex: a pre-post intervention study.

BACKGROUND: Daily aerobic exercise such as healthy walking could have an immediate effect on parameters of arterial stiffness; however, there is little evidence in the diabetic population. Our aim, therefore, is to evaluate the association between healthy walking and acute effects on the parameters of arterial stiffness in subjects with type 2 diabetes. METHODS: The Effectiveness of a multifactorial intervention in diabetics study (EMID), is a study based on an application for smartphones, healthy walking and a nutritional workshop in patients with type 2 diabetes in primary care, is a randomized controlled trial of two parallel groups. This is a subanalysis of the intervention group to evaluate the response to the healthy walking according to age and sex, in 89 subjects with type 2 diabetes, aged between 40 and 70 years. The intervention was a 4 km of a healthy walking at low-moderate intensity. To value our aim, the main study variables were measured before and after it. RESULTS: The study population had an average age of 65.0 years (61.2-68.1). After the healthy walking, there was a decrease in the parameters of arterial stiffness: Cardio ankle vascular index (CAVI) of - 0.2 (95%CI:-0.4 to - 0.1) and pulse pressure (PP) of the lower extremities of - 3.9 mmHg (95%CI: -5.9 to - 2.0). Furthermore, in the lower extremities there was a decrease in systolic blood pressure of - 5.3 mmHg (95% CI: -7.3 mmHg to - 3.3 mmHg), in diastolic blood pressure of - 1.5 mmHg (95% CI: -2.6 mmHg to - 0.4 mmHg) (p < 0.05 for all). It is observed that males have an OR of 2.981 (IC = 95% 1.095 to 8.119) to achieve a reduction in the CAVI (p < 0.05) and an OR of 2.433 (95%CI: 0.871 to 6.794) in the ankle PP (p > 0.05), compared with females. CONCLUSIONS: The findings of this study suggest that daily aerobic exercise at a low to moderate intensity, such as healthy walking, has an immediate beneficial effect on the cardio-ankle vascular index, especially in males. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02991079 .

Effect of a multifactorial intervention on the increase in physical activity in subjects with type 2 diabetes mellitus: a randomized clinical trial (EMID Study).

BACKGROUND: Regular physical activity is essential for metabolic control in type 2 diabetes mellitus. AIMS: The aim of this study was to assess the short and long-term impact of a multifactorial intervention on physical activity and clinically relevant biochemical parameters in patients with type 2 diabetes mellitus. METHODS: This randomised, controlled clinical trial (NCT02991079) included two parallel groups aged 25-70 years from a primary care health centre in Salamanca, Spain. The subjects were assigned randomly (1:1) to control and intervention groups, using Epidat 4.0 software. Both were counselled on the importance of physical activity and maintaining a healthy diet. The intervention group also took five low-moderate intensity 4 km nurse-guided walks, received a smartphone application to promote healthy habits and attended a diet workshop. Physical activity was measured objectively using a pedometer and subjectively using a shortened international physical activity questionnaire (at baseline, 3 and 12 months). RESULTS: In total, 204 subjects were included (mean age 60.6 years, 45.6% were women). After 3 months, relative to the control group, the intervention group increased their daily number of steps by 1852, aerobic steps by 1623, distance walked by 994 m, and total metabolic equivalent minutes per week by 1297 and decreased sedentary time by 34.3 minutes per day. Differences from baseline persisted at 12 months, including mean increases of 1141 daily steps, 917 aerobic steps, and 1065 total metabolic equivalent minutes per week in the intervention group relative to the control group ( P<0.05 for all). CONCLUSIONS: The success of this multifactorial intervention should help inform future clinical approaches and application designs towards managing type 2 diabetes mellitus and improving patient outcomes.

Effectiveness of A Multifactorial Intervention in Increasing Adherence to the Mediterranean Diet among Patients with Diabetes Mellitus Type 2: A Controlled and Randomized Study (EMID Study).

The Mediterranean diet (MD) is recognized as one of the healthiest dietary patterns and has benefits such as improving glycaemic control among patients with type 2 diabetes (T2DM). Our aim is to assess the effectiveness of a multifactorial intervention to improve adherence to the MD, diet quality and biomedical parameters. The EMID study is a randomized and controlled clinical trial with two parallel groups and a 12-month follow-up period. The study included 204 subjects between 25⁻70 years with T2DM. The participants were randomized into intervention group (IG) and control group (CG). Both groups received brief advice about healthy eating and physical activity. The IG participants additionally took part in a food workshop, five walks and received a smartphone application for three months. The population studied had a mean age of 60.6 years. At the 3-month follow-up visit, there were improvements in adherence to the MD and diet quality of 2.2 and 2.5 points, compared to the baseline visit, respectively, in favour of the IG. This tendency of the improvement was maintained, in favour of the IG, at the 12-month follow-up visit. In conclusion, the multifactorial intervention performed could improve adherence to the MD and diet quality among patients with T2DM.

EVIDENT 3 Study: A randomized, controlled clinical trial to reduce inactivity and caloric intake in sedentary and overweight or obese people using a smartphone application: Study protocol.

INTRODUCTION: Mobile technology, when included within multicomponent interventions, could contribute to more effective weight loss. The objective of this project is to assess the impact of adding the use of the EVIDENT 3 application, designed to promote healthy living habits, to traditional modification strategies employed for weight loss. Other targeted behaviors (walking, caloric-intake, sitting time) and outcomes (quality of life, inflammatory markers, measurements of arterial aging) will also be evaluated. METHODS: Randomized, multicentre clinical trial with 2 parallel groups. The study will be conducted in the primary care setting and will include 700 subjects 20 to 65 years, with a body mass index (27.5-40 kg/m), who are clinically classified as sedentary. The primary outcome will be weight loss. Secondary outcomes will include change in walking (steps/d), sitting time (min/wk), caloric intake (kcal/d), quality of life, arterial aging (augmentation index), and pro-inflammatory marker levels. Outcomes will be measured at baseline, after 3 months, and after 1 year. Participants will be randomly assigned to either the intervention group (IG) or the control group (CG). Both groups will receive the traditional primary care lifestyle counseling prior to randomization. The subjects in the IG will be lent a smartphone and a smartband for a 3-month period, corresponding to the length of the intervention. The EVIDENT 3 application integrates the information collected by the smartband on physical activity and the self-reported information by participants on daily food intake. Using this information, the application generates recommendations and personalized goals for weight loss. DISCUSSION: There is a great diversity in the applications used obtaining different results on lifestyle improvement and weight loss. The populations studied are not homogeneous and generate different results. The results of this study will help our understanding of the efficacy of new technologies, combined with traditional counseling, towards reducing obesity and enabling healthier lifestyles. ETHICS AND DISSEMINATION: The study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca ("CREC of Health Area of Salamanca") on April 2016. A SPIRIT checklist is available for this protocol. The trial was registered in ClinicalTrials.gov provided by the US National Library of Medicine-number NCT03175614.

Effectiveness of an intensive intervention to improve lifestyles in people with intermediate cardiovascular risk (DATE study): Study protocol for a randomized controlled trial.

AIM: The aim of this study was to evaluate the effectiveness of an intensive intervention led by primary care nurses for lifestyle modification among people with intermediate cardiovascular risk. BACKGROUND: Cardiovascular diseases may be prevented by adopting healthy lifestyles. Interventions focused on populations at risk are more efficient than those aimed at the general population. More than 50 per cent of cardiovascular events occur in people with intermediate cardiovascular risk, but only a few studies have targeted this population. DESIGN: A randomized controlled trial approved in January 2017. METHODS: We will recruit 208 participants aged 35-74 years who have intermediate cardiovascular risk. They will be selected by consecutive sampling and will be randomized into a control group or intervention group. Individual standardized brief counselling on healthy lifestyles will be provided to both groups. Additionally, individuals from the intervention group will receive four weekly group sessions focusing on cardiovascular risk, healthy diet, moderation in alcohol consumption, daily physical activity, stress management and smoking cessation and two motivational follow-up calls. The primary outcome will be the lifestyle modification measured by total steps recorded by a pedometer, total score on the Mediterranean Diet Adherence Screener and percentage of current smokers. DISCUSSION: This study will allow us to investigate whether an intensive intervention based on a multifactorial group approach is more effective in lifestyle modification than individual standardized brief counseling among adults with intermediate cardiovascular risk. Our results could lead to the establishment of new strategies for cardiovascular risk management.