Preliminary Effects of a Structured Educational Program in Cardiac Patients at Different Stages of Enrollment in Cardiovascular Rehabilitation.

This quasi-experimental study investigated the preliminary effects of a structured education intervention in a pooled sample of cardiovascular rehabilitation (CR) patients in Brazil. Recently enrolled (RE) and long-term enrolled (LTE) patients attended 12 weekly education sessions in addition to three weekly exercise sessions. Patients completed surveys assessing disease-related knowledge, physical activity, food intake, self-efficacy, and health literacy. Functional capacity was assessed by the 6-minutes walking test. All outcomes were assessed at pre-,post-CR, and 6-months follow-up. Bonferroni correction was applied. In total, 69 (69.7%) patients completed all three assessments. There were significant improvements in knowledge pre-to post-test in both subgroups (p < 0.001), and in functional capacity (p ≤ 0.001) and food intake (p ≤ 0.001) pre-to post-test in the RE subgroup. Post-test knowledge was correlated to physical activity, functional capacity and health literacy. This preliminary study suggests the importance of structured education for CR patients. A larger study using a randomized controlled design is needed to determine efficacy.

Characteristics and correlates of disease-related knowledge and exercise self-efficacy among cardiac patients attending virtual cardiac rehabilitation during the first COVID-19 lockdown in Peru.

BACKGROUND: Government responses and restrictions due to the COVID-19 pandemic (e.g., limits to non-urgent health care services, including non-urgent outpatient appointments) led to the suspension of center-based (in-person) cardiac rehabilitation (CR), with many programs switching to virtual delivery. This study aimed to understand the characteristics and correlates of disease-related knowledge and exercise self-efficacy in a group of patients attending a virtual CR program during the first COVID-19 lockdown in Peru. METHODS: In this prospective observational study, 240 patients receiving virtual CR care (exercise instructions and patient education) between August/2020 and December/2021 completed questionnaires pre- and post-CR assessing disease-related knowledge (CADE-Q SV questionnaire) and self-efficacy (SE; Bandura's Exercise SE scale). Paired t tests were used to investigate changes pre/post-CR and Pearson correlation coefficients were used to determine the association between knowledge/SE and patients' characteristics. RESULTS: Participants were mainly comprised of men, with a cardiac diagnosis of stable coronary artery disease, who underwent percutaneous coronary intervention or had a known diagnosis of hypertension and with at least one cardiovascular risk factor (95.8%). Mean total knowledge scores improved significantly at post-CR (12.9 ± 2.4 to 15.6 ± 2.0/20; p<0.001), as well as in 4/5 knowledge areas (cardiovascular risk factors, exercise, nutrition, and psychosocial risk; p<0.001). Mean SE scores improved significantly at post-CR (1.9 ± 0.9 to 3.0 ± 0.9/5; p = 0.01). Post-CR knowledge and SE were significantly correlated with cardiac diagnosis and surgical procedures (r = 0.17, p = 0.02 and r = 0.27, p = 0.02, respectively). CONCLUSIONS: The virtual CR program improved disease-related knowledge and SE of cardiac patients during the first months of the COVID-19 pandemic. Post-CR outcomes were correlated with cardiac diagnosis and surgical procedures and more research with other characteristics is warrantied.

Feasibility of a Virtual Educational Programme for Behaviour Change in Cardiac Patients from a Low-Resource Setting.

Patient education is an integral part of recovery from a critical cardiac life event and a core component of cardiac rehabilitation (CR) programmes. This study addressed the feasibility of a virtual educational programme for behaviour change in CR patients from a low-resource setting in Brazil. Cardiac patients from a CR programme closed due to the pandemic received a 12-week virtual educational intervention (WhatsApp messages and bi-weekly calls from healthcare providers). Acceptability, demand, implementation, practicality, and limited efficacy were tested. Overall, 34 patients and 8 healthcare providers agreed to participate. The intervention was considered practical and acceptable by the participants, who reported a satisfaction median of 9.0 (7.4-10.0)/10 (patients) and 9.8 (9.6-10.0)/10 (providers). The main difficulties in carrying out the intervention activities were related to technology, motivation to self-learning, and a lack of in-person orientation. All the patients reported that the information included in the intervention was aligned with their information needs. The intervention was associated with changes in exercise self-efficacy, sleep quality, depressive symptoms, and performance of high-intensity physical activity. In conclusion, the intervention was considered feasible to educate cardiac patients from a low-resource setting. It should be replicated and expanded to support patients that face barriers to onsite CR participation. Challenges related to technology and self-learning should be addressed.

Feasibility of Remote Delivering an Exercise and Lifestyle Education Program for Individuals Living with Prediabetes and Diabetes in Brazil.

This study aimed to test the feasibility of remote delivering a 12-week exercise and lifestyle education program (ExLE) or a 12-week exercise program (Ex) for individuals with prediabetes and diabetes in terms of acceptability, implementation, practicality, and limited efficacy. The programs were internet- or telephone-based delivered, depending on the participants' internet access and technology literacy. Of the 196 individuals screened, 15 were included in the study (internet-based delivery (n = 13); telephone-based delivery (n = 2)). Twelve participants completed the program they were randomized to, and most reported being satisfied with the study interventions (acceptability). Data collection procedures, weekly follow-up, study website visits, and educational materials were proper (implementation), and the adherence rate to study interventions ranged from 24% to 58% (practicality). Additionally, both programs (ExLE and Ex) seemed to promote beneficial changes in functional capacity (limited efficacy). The internet-based remote delivery of the interventions showed feasibility. Therefore, in future trials, exercise and educational interventions can be internet-based remote delivered to individuals with prediabetes and diabetes with internet access and technology literacy. In addition, some adjustments to eligibility criteria, study websites, more accessible ways of recording exercise sessions and using educational materials, and an initial supervised exercise session are recommended.

Development of the Brazilian Version of a Pan-Canadian Behavior Change Program and Its Health and Fitness Outcomes.

Chronic diseases are a major health problem worldwide, especially in lower-income jurisdictions. Considering this scenario, the World Health Organization has recently established, as a research priority, preventive interventions for populations from lower-income countries, such as the middle-income country of Brazil. The purpose of this article is to describe the components of a pan-Canadian lifestyle program adapted to Brazilians and to report its health and fitness outcomes. A 12-week program called ACCELERATION was translated and culturally adapted to Brazilians. A quasi-randomized controlled trial was designed, consisting of weekly emails and educational videos addressing risk factors for chronic disease. Health and fitness measures included body composition, cardiovascular variables, aerobic fitness, and muscular strength. The Brazilian experimental group showed maintenance in heart rate, blood pressure, and VO2max values while presenting an improvement of 3.3% in body fat percentage (p = 0.040, d = -0.325) and 5.1% in muscular strength (p = 0.039, d = 0.328). Overall, these results were similar to the Canadian intervention. Based on these findings, the Brazilian version of the program has the potential to contribute to the fight against chronic diseases in Brazil.

Exercise and Lifestyle Education program for Brazilians living with prediabetes and diabetes: A pilot randomized trial.

AIMS: To test the Diabetes College Brazil Study feasibility, the acceptability of study interventions and their preliminary effectiveness, and describe the study protocol modifications due to the COVID-19 pandemic. METHODS: Single-center, double-blinded pilot randomized trial with two parallel groups, Exercise and Lifestyle Education (ExLE; 12-week exercise and educational interventions) and Exercise (Ex; 12-week exercise intervention only) involving patients with prediabetes or diabetes. Feasibility (eligibility, recruitment, retention, completeness of variables measures and participation rates), acceptability (satisfaction), and preliminary effectiveness of interventions (variables: functional capacity, physical activity (PA), exercise self-efficacy, diabetes knowledge, health literacy, adherence to Mediterranean food pattern, glycated hemoglobin (HbA1c), anthropometric measures, cardiac autonomic control, depression, and quality of life (QofL)). RESULTS: Eligibility, recruitment, retention, participation in exercise sessions, and education classes rates were 17%, 93%,82%, 76%, and 71%, respectively. Missing data in the post-intervention assessment (PA, HbA1c, cardiac autonomic control, anthropometric measures, depression, and QofL) were mainly related to research procedure modifications. The interventions were highly acceptable, and most variables improved farther in the ExLE, with moderate effect sizes for PA, diabetes knowledge, health literacy, cardiac autonomic control, and QofL. CONCLUSIONS: The Diabetes College Brazil Study is feasible, and the ExLE may benefit Brazilians living with prediabetes and diabetes.

Percepções dos Participantes de Reabilitação Cardíaca sobre seus Comportamentos em Saúde e Necessidades de Informação durante a Pandemia COVID-19 no Brasil / Perceptions of Cardiac Rehabilitation Participants Regarding their Health Behaviors and Information Needs during the COVID-19 Pandemic in Brazil

Resumo Fundamento A COVID-19 afetou como as pessoas recebem atendimento de saúde para várias doenças, inclusive doenças cardiovasculares. Objetivos Examinar as percepções dos participantes de reabilitação cardíaca (RC) sobre seus comportamentos em saúde e necessidades de informação durante a pandemia da COVID-19 no Brasil. Métodos Neste estudo transversal, um questionário de 27 itens elaborado pelos investigadores foi administrado online a participantes de dois programas de RC. As perguntas incluíam letramento em saúde (LS; usando a Brief Health Literacy Screening Tool - Breve ferramenta de triagem de letramento em saúde), uso de tecnologia, percepções antes e durante a pandemia da COVID-19, e necessidades de informações. Foram usados coeficiente de correlação de Pearson, testes t pareados e ANOVA, conforme apropriado. Um p <0,05 foi considerado estatisticamente significativo para todos os testes. Resultados No total, 159 (25,5%) participantes de RC responderam ao questionário. Desses, 89,9% tinham LS limitado ou marginal, e 96,2% relataram ter acesso à internet de casa. Os pacientes se preocupam principalmente com a saúde de sua família e própria, além de como o coronavírus é perigoso para sua saúde e como mudou seu estilo de vida. Os participantes perceberam que a qualidade de seus comportamentos em saúde diminuiu significativamente durante a pandemia. A pandemia também mudou as necessidades de informações dos participantes de RC, já que novas necessidades surgiram, tais como, controle de níveis de ansiedade, manter a motivação para levar uma vida saudável durante a pandemia, e como a COVID-19 pode afetar sua condição de saúde. Participantes com LS adequado perceberam significativamente a gravidade da doença e tinham significativamente mais acesso a informações do que os pacientes com LS limitado. Conclusões Nossos resultados destacaram o impacto da pandemia nas percepções dos participantes de RC em relação a seus comportamentos em saúde e necessidades de informação, que podem ser influenciados pelos níveis de LS.

Abstract Background COVID-19 has impacted how people receive health care for many conditions, including cardiovascular diseases. Objectives To examine perceptions of cardiac rehabilitation (CR) participants regarding their health behaviors and information needs during the COVID-19 pandemic in Brazil. Methods In this cross-sectional study, a 27-item questionnaire, developed by the investigators, was administered online to participants from two CR programs. Questions included health literacy (HL; using the Brief Health Literacy Screening Tool), technology use, perceptions before and during the COVID-19 pandemic, and information needs. Pearson correlation coefficients, paired t-tests, and ANOVA were used as appropriate. P < 0.05 was considered statistically significant for all tests. Results Overall, 159 (25.5%) CR participants answered the questionnaire. Of these, 89.9% had limited or marginal HL and 96.2% reported having internet access at home. Patients are mainly concerned about their family's health and their own, as well as how the coronavirus is dangerous to their health and how it has changed their lifestyle. Participants perceived that the quality of their health behaviors significantly decreased during the pandemic. The pandemic also changed information needs of CR participants as new needs emerged, such as the control of anxiety levels, staying motivated to live healthily during a pandemic, and how COVID-19 can impact their health condition. Participants with adequate HL significantly perceived the severity of the disease and having access to information significantly more than those with limited HL. Conclusions Our results highlighted the impact of the pandemic on CR participants' perceptions regarding their health behaviors and information needs, which can be influenced by HL levels.

Perceptions of Cardiac Rehabilitation Participants Regarding their Health Behaviors and Information Needs during the COVID-19 Pandemic in Brazil. / Percepções dos Participantes de Reabilitação Cardíaca sobre seus Comportamentos em Saúde e Necessidades de Informação durante a Pandemia COVID-19 no Brasil.

BACKGROUND: COVID-19 has impacted how people receive health care for many conditions, including cardiovascular diseases. OBJECTIVES: To examine perceptions of cardiac rehabilitation (CR) participants regarding their health behaviors and information needs during the COVID-19 pandemic in Brazil. METHODS: In this cross-sectional study, a 27-item questionnaire, developed by the investigators, was administered online to participants from two CR programs. Questions included health literacy (HL; using the Brief Health Literacy Screening Tool), technology use, perceptions before and during the COVID-19 pandemic, and information needs. Pearson correlation coefficients, paired t-tests, and ANOVA were used as appropriate. P < 0.05 was considered statistically significant for all tests. RESULTS: Overall, 159 (25.5%) CR participants answered the questionnaire. Of these, 89.9% had limited or marginal HL and 96.2% reported having internet access at home. Patients are mainly concerned about their family's health and their own, as well as how the coronavirus is dangerous to their health and how it has changed their lifestyle. Participants perceived that the quality of their health behaviors significantly decreased during the pandemic. The pandemic also changed information needs of CR participants as new needs emerged, such as the control of anxiety levels, staying motivated to live healthily during a pandemic, and how COVID-19 can impact their health condition. Participants with adequate HL significantly perceived the severity of the disease and having access to information significantly more than those with limited HL. CONCLUSIONS: Our results highlighted the impact of the pandemic on CR participants' perceptions regarding their health behaviors and information needs, which can be influenced by HL levels.

FUNDAMENTO: A COVID-19 afetou como as pessoas recebem atendimento de saúde para várias doenças, inclusive doenças cardiovasculares. OBJETIVOS: Examinar as percepções dos participantes de reabilitação cardíaca (RC) sobre seus comportamentos em saúde e necessidades de informação durante a pandemia da COVID-19 no Brasil. MÉTODOS: Neste estudo transversal, um questionário de 27 itens elaborado pelos investigadores foi administrado online a participantes de dois programas de RC. As perguntas incluíam letramento em saúde (LS; usando a Brief Health Literacy Screening Tool - Breve ferramenta de triagem de letramento em saúde), uso de tecnologia, percepções antes e durante a pandemia da COVID-19, e necessidades de informações. Foram usados coeficiente de correlação de Pearson, testes t pareados e ANOVA, conforme apropriado. Um p <0,05 foi considerado estatisticamente significativo para todos os testes. RESULTADOS: No total, 159 (25,5%) participantes de RC responderam ao questionário. Desses, 89,9% tinham LS limitado ou marginal, e 96,2% relataram ter acesso à internet de casa. Os pacientes se preocupam principalmente com a saúde de sua família e própria, além de como o coronavírus é perigoso para sua saúde e como mudou seu estilo de vida. Os participantes perceberam que a qualidade de seus comportamentos em saúde diminuiu significativamente durante a pandemia. A pandemia também mudou as necessidades de informações dos participantes de RC, já que novas necessidades surgiram, tais como, controle de níveis de ansiedade, manter a motivação para levar uma vida saudável durante a pandemia, e como a COVID-19 pode afetar sua condição de saúde. Participantes com LS adequado perceberam significativamente a gravidade da doença e tinham significativamente mais acesso a informações do que os pacientes com LS limitado. CONCLUSÕES: Nossos resultados destacaram o impacto da pandemia nas percepções dos participantes de RC em relação a seus comportamentos em saúde e necessidades de informação, que podem ser influenciados pelos níveis de LS.

A Critical Review on New Approaches for Chronic Disease Prevention in Brazil and Canada: From Wholistic Dietary Guidelines to Physical Activity Security.

In light of new evidence on the prevention of chronic diseases and the elevated rates of overweight and obesity in Brazil and Canada, this critical review aims to interpret and synthesize current aspects regarding dietary and physical activity initiatives in both countries and make future recommendations. The pioneering work presented in the last Brazilian dietary guidelines has been called a model that can be applied globally, given its conceptualization of healthy eating that translates easily to practical guidance. The new Canadian Food Guide has incorporated similar aspects, also putting the country as a leader in dietary guidance. With these new recommendations, citizens in both Brazil and Canada have access to impactful evidence-informed nutritional guidelines. Both documents propose eating patterns that focus not only on health benefits, such as chronic disease prevention, but also incorporate well-being concerning cultural, economic, sociodemographic, biological, and ecological dimensions. A similar approach is required for physical activity to allow individuals to have attainable health and life goals and thereby fully enjoy their lives, regardless of geographical location, health status, and socioeconomic condition, a concept recently described as physical activity security. The wholistic dietary guidelines from both countries represent a change in paradigm in public health. Likewise, national evidence-based policies are warranted to reduce disparities in physical activity, allowing healthier and more active lifestyles for everyone.

Barriers and facilitators to participant adherence of dietary recommendations within comprehensive cardiac rehabilitation programmes: a systematic review.

OBJECTIVE: To identify individual-, provider- and system/environmental-level barriers and facilitators affecting cardiac rehabilitation (CR) participants' adherence to dietary recommendations. DESIGN: A systematic review of the medical literature was conducted. Six databases were searched from inception through March 2021: APA PsycInfo, CINAHL, Embase, Emcare, Medline and PubMed. Only those studies referring to barriers and facilitators reported by CR participants were considered. Pilot and case report studies, non-peer-reviewed literature and studies published in a language other than English, Portuguese or Spanish were excluded. RESULTS: Data were extracted and analysed on the basis of individual-, provider- and system/environmental-level factors. Of 2083 initial citations, sixteen studies were included, with nine being qualitative and seven observational in design. From these, ten multi-level barriers and seven multi-level facilitators were identified. Dietary recommendations included developing healthy eating habits, transitioning to vegetarian-rich diets and increasing fish oil and n-3 intake. Only one study reported on all of the nutrition education programme factors recommended by the Workgroup for Intervention Development and Evaluation Research. CONCLUSION: To the best of our knowledge, this review is the first to summarise specific barriers and facilitators to recommendation adherence among CR participants. Few of the studies offered any conclusions regarding programme design that could facilitate improved dietary adherence practices. Future studies should aim to explore patient perspectives on the nutritional patterns and recommendations outlined in the Mediterranean Diet, the Dietary Approaches to Stop Hypertension Diet, Vegetarian or Vegan diets and the Portfolio Diet.

Translation, Cultural Adaptation, and Reproducibility of the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+): The Brazilian Portuguese Version.

Background: The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) is the international standard for pre-participation risk stratification and screening. In order to provide a practical and valid screening tool to facilitate safe engagement in physical activity and fitness assessments for the Brazilian population, this study aimed to translate, culturally adapt, and verify the reproducibility of the evidence-based PAR-Q+ to the Brazilian Portuguese language. Method: Initially, the document was translated by two independent translators, before Brazilian experts in health and physical activity evaluated the translations and produced a common initial version. Next, two English native speakers, fluent in Brazilian Portuguese and accustomed to the local culture, back-translated the questionnaire. These back translations were assessed by the organization in charge of the PAR-Q+, then a final Brazilian version was approved. A total of 493 Brazilians between 5 and 93 yr (39.9 ± 25.4 yr), 59% female, with varying levels of health and physical activity, completed the questionnaire twice, in person or online, 1-2 weeks apart. Cronbach's alpha was used to calculate the internal consistency of all items of the questionnaire, and the Kappa statistic was used to assess the individual reproducibility of each item of the document. Additionally, the intraclass correlation coefficient and its 95% confidence interval (CI) were used to verify the general reproducibility (reliability) of the translated version. Results: The Brazilian version had an excellent internal consistency (0.993), with an almost perfect agreement in 93.8% of the questions, and a substantial agreement in the other 6.2%. The translated version also had a good to excellent total reproducibility (0.901, 95% CI: 0.887-0.914). Conclusion: The results show this translation is a valid and reliable screening tool, which may facilitate a larger number of Brazilians to start or increase physical activity participation in a safe manner.

Patient education program for Brazilians living with diabetes and prediabetes: findings from a development study.

BACKGROUND: Globally, the incidence of diabetes is increasing and strategies to reach a comprehensive approach of care are needed, including education in self-management. This is particularly true in low and middle-income countries where the number of people living with diabetes is higher than in the high-income ones. This article describes the development of a structured patient education program for Brazilians living with diabetes or prediabetes. METHODS: These steps were undertaken: 1) a 4-phase needs assessment (literature search of local diabetes guidelines, environmental scan, evaluation of information needs of patients identified by diabetes experts, and patient focus groups); and, 2) the translation and cultural adaptation of the patient guide (preparation, translation, back-translation, back-translation review, harmonization, and proofreading). RESULTS: Four of the seven guidelines identified include educational aspects of diabetes management. No structured education program was reported from the environmental scan. Regarding the information needs, 15 diabetes experts identified their patients' needs, who referred that they have high information needs for topics related to their health condition. Finally, results from six patient focus groups were clustered into six themes (self-management, physical activity, eating habits, diabetes medication, psychosocial being, and sleep), all embedded into the new education program. Constructive theory, adult learning principles, and the Health Action Process Approach model were used in program development and will be used in delivery. The developed program consists of 18 educational sessions strategically mapped and sequenced to support the program learning outcomes and a patient guide with 17 chapters organized into five sections, matched with weekly lectures. CONCLUSIONS: This program is a sequential and theoretical strategic intervention that can reach programs in Brazil to support diabetes and prediabetes patient education.

Barriers to Cardiac Rehabilitation in Ethnic Minority Groups: A Scoping Review.

Cardiac rehabilitation (CR) is under-utilized by ethnic minorities. This study aimed to identify barriers associated with referral, enrollment, and completion/adherence of CR for cardiac participants from ethnic minorities. Medline, Embase, Emcare, CINAHL, Pubmed and APA PsycInfo were searched from data inception through January 2020. We excluded studies referring to race minorities, considering barriers reported by providers or family members, and those published in languages other than English or Portuguese. Data was extracted in an individual, provider, and system level. Of 1847 initial citations, 20 studies were included, with most being qualitative in design and classified as "good" quality. Overall, 12 multi-level barriers were identified in the three CR participation phases, with language being present in all phases. Barriers reported in ethnic minority groups are multi-level. Although identified, literature did not support recommendations to overcome these barriers and clearly more research in this area is needed.

Translation and evaluation of a comprehensive educational program for cardiac rehabilitation patients in Latin America: A multi-national, longitudinal study.

OBJECTIVES: To translate, cross-culturally adapt and validate a comprehensive evidence- and theoretically-based CR education intervention in Latin America. METHODS: First, best practices in translation and cross-cultural adaptation were applied through 6 steps. Then, the Spanish version was delivered to CR participants from programs in Colombia, Costa Rica and Peru for validation, such that the evaluation was pre-post, uncontrolled, pragmatic, observational, and prospective in design. Participants completed surveys assessing knowledge, health literacy, self-efficacy, and health behaviours. All outcomes were assessed pre-, and post-CR, as well as 6 months after CR completion. RESULTS: After translation of the patient guide from English to Spanish, 5 of the 9 booklets were culturally adapted. Two-hundred and forty-nine patients consented to participate, of which 184 (74 %) completed post-CR, and 121 (48 %) completed final assessments. There was a significant improvement in disease-related knowledge pre- to post-CR, as well as in health literacy, self-efficacy, and health behaviours (all p < 0.05). These gains were sustained 6 months post-program. With adjustment, CR attendance (i.e., exposure to the education) was associated with greater post-CR knowledge (ß = 0.026; p = 0.01). CONCLUSION: A patient education intervention for CR patients in Latin America has been validated, and wider implementation is warranted. PRACTICE IMPLICATIONS: Application of this first-ever validated CR education program for Spanish-speaking settings may result in secondary prevention.

Comprehensive Cardiac Rehabilitation Effectiveness in a Middle-Income Setting: A RANDOMIZED CONTROLLED TRIAL.

PURPOSE: The impact of comprehensive cardiac rehabilitation (CCR) in Latin America is not well known. Herein, the pre-specified tertiary outcomes of a cardiac rehabilitation (CR) trial are reported: disease-related knowledge, depressive symptoms, and heart-health behaviors (exercise, diet, and smoking). METHODS: This was a single-blinded, single-center (Brazil) randomized trial with three parallel arms: CCR (exercise + education) versus exercise-only CR versus wait-list control. Eligible patients were randomized in blocks of four with 1:1:1 concealed allocation. The CR program was 6 mo long. Participants randomized to exercise-only CR received 36 exercise classes; the CCR group also received 24 educational sessions, including a workbook. All outcomes were assessed at pre-test and 6-mo later (blinded). Analysis of covariance was performed by intention-to-treat (ITT) and per-protocol (PP). RESULTS: A total of 115 (89%) patients were randomized; 93 (81%) were retained. There were significant improvements in knowledge with CCR (ITT [51.2 ± 11.9 pre and 60.8 ± 13.2 post] and PP; P < .01), with significantly greater knowledge with CCR versus control (ITT mean difference [MD] = 9.5, 95% CI, 2.3-16.8) and CCR vs exercise-only CR at post-test (ITT MD = 6.8, 95% CI, 0.3-14.0). There were also significant improvements in self-reported exercise with CCR (ITT [13.7 ± 15.8 pre and 32.1 ± 2 5.7 post] and PP; P < .001), with significantly greater exercise with CCR versus control at post-test (ITT MD = 7.6, 95% CI, 3.8-11.4). Also, there were significant improvements in diet with CCR (PP: 3.4 ± 7.5 pre and 8.0 ± 7.0 post; P < .05). CONCLUSIONS: In this first-ever randomized trial of CR for coronary artery disease in Latin America, the benefits of CCR have been supported.

Effects of comprehensive cardiac rehabilitation on functional capacity in a middle-income country: a randomised controlled trial.

OBJECTIVE: Despite the growing epidemic of cardiovascular diseases in middle-income countries, there is insufficient evidence about cardiac rehabilitation (CR) in these countries. Thus, the effects of comprehensive CR on functional capacity and risk factors were investigated in Brazil, to test the hypothesis that it results in better outcomes than exercise-only or no CR. METHODS: Single-blinded, randomised controlled trial with three parallel arms: comprehensive CR (exercise+education) versus exercise-only CR versus wait-list control. Eligible coronary patients were randomised in blocks of four with 1:1:1 concealed allocation. Participants randomised to exercise-only CR received 36 exercise classes; comprehensive CR group also received 24 educational sessions. The primary outcome was incremental shuttle walk test (ISWT) distance; secondary outcomes were cardiovascular risk factors. All outcomes were assessed at baseline and 6 months later. Analysis of covariance was performed on the basis of intention-to-treat (ITT) and per-protocol. RESULTS: 115 (88.5%) patients were randomised; 93 (80.9%) were retained. There were improvements in ISWT distance from pretest to post-test with comprehensive (from 358.4±132.6 to 464.8±121.6 m; mean change=106.4; p<0.001) and exercise-only (from 391.5±118.8 to 488.1±106.3 m; mean change=96.5, p<0.001) CR, with significantly greater functional capacity with comprehensive CR versus control (ITT: mean difference=75.6±30.7 m, 95% CI 1.4 to 150.2). There were also reductions in systolic blood pressure with comprehensive CR (ITT: reduction of 6.2±17.8 mm Hg, p=0.04). There were no significant differences for other outcomes. CONCLUSION: Results showed clinically significant improvements in functional capacity and blood pressure with CR, and significantly greater functional capacity with comprehensive CR compared with usual care. TRIAL REGISTRATION NUMBER: NCT02575976; Results.

Identification and Management of Statin-Associated Symptoms in Clinical Practice: Extension of a Clinician Survey to 12 Further Countries.

PURPOSE: Statins are the first-choice pharmacological treatment for patients with hypercholesterolemia and at risk for cardiovascular disease; however, a minority of patients experience statin-associated symptoms (SAS) and are considered to have reduced statin tolerance. The objective of this study was to establish how patients with SAS are identified and managed in clinical practice in Austria, Belgium, Colombia, Croatia, the Czech Republic, Denmark, Portugal, Switzerland, Russia, Saudi Arabia, Turkey, and the United Arab Emirates. METHODS: A cross-sectional survey was conducted (2015-2016) among clinicians (n = 60 per country; Croatia: n = 30) who are specialized/experienced in the treatment of hypercholesterolemia. Participants were asked about their experience of patients presenting with potential SAS and how such patients were identified and treated. RESULTS: Muscle-related symptoms were the most common presentation of potential SAS (average: 51%; range across countries [RAC] 17-74%); other signs/symptoms included persistent elevation in transaminases. To establish whether symptoms are due to statins, clinicians required rechallenge after discontinuation of statin treatment (average: 77%; RAC 40-90%); other requirements included trying at least one alternative statin. Clinicians reported that half of high-risk patients with confirmed SAS receive a lower-dose statin (average: 53%; RAC 43-72%), and that most receive another non-statin lipid-lowering therapy with or without a concomitant statin (average: 65%; RAC 52-83%). CONCLUSIONS: The specialists and GPs surveyed use stringent criteria to establish causality between statin use and signs or symptoms, and persevere with statin treatment where possible.

Validation of the portuguese version of the tampa scale for kinesiophobia heart (TSK-SV heart) / Validação da versão em português da escala de tampa para cinesiofobia cardíaca (TSK-SV cardíaca) / Validación de la versión en portugués de la escala de tampa para kinesiofobia cardiaca (TSK-SV cardiaca)

ABSTRACT Introduction: It has been shown that kinesiophobia has a negative influence on the outcomes of cardiac rehabilitation and consequently is important for the clinical setting. Objective: The objective of this study was to translate, culturally adapt, and psychometrically validate the Tampa Scale for Kinesiophobia Heart (TSK-SV Heart) to Brazilian Portuguese. Methods: The Portuguese version was tested in 300 patients in cardiac rehabilitation. Test-retest reliability was assessed by intraclass correlation coefficient, internal consistency by Cronbach's alpha, and criterion validity was assessed with respect to patients' education, income, duration of cardiac rehabilitation, and sex. Results: After intraclass correlation coefficient analysis, one item was excluded. All four areas were considered internally consistent (α >0.7). Significant differences between mean total scores and income (p<0.01) supported the criterion validity. Two hundred sixty-nine (89.6%) patients had a high level of kinesiophobia (scores > 37). Conclusions: The Brazilian Portuguese version of TSK-SV Heart demonstrated sufficient reliability, consistency and validity, supporting its use in future studies.

RESUMO Introdução: Demonstrou-se que a cinesiofobia tem influência negativa sobre os resultados da reabilitação cardíaca e, consequentemente, é importante no contexto clínico. Objetivo: O objetivo deste estudo foi traduzir, fazer a adaptação cultural e validar em termos psicométricos a Escala de Tampa para Cinesiofobia Cardíaca (TSK-SV Cardíaca) para o português do Brasil. Métodos: A versão em português foi testada em 300 pacientes em reabilitação cardíaca. A confiabilidade teste-reteste foi avaliada pelo coeficiente de correlação intraclasse, a consistência interna pelo alfa de Cronbach, e a validade de critério foi avaliada no que diz respeito a educação dos pacientes, renda, duração da reabilitação cardíaca e sexo. Resultados: Após análise do coeficiente de correlação intraclasse, um item foi excluído. Todas as quatro áreas foram consideradas internamente consistentes (α > 0,7). As diferenças significativas entre os escores totais médios e de renda (p < 0,01) apoiaram a validade de critério. Duzentos e sessenta e nove (89,6%) pacientes apresentavam um alto nível de cinesiofobia (escore > 37). Conclusões: A versão em português do Brasil da TSK-SV Cardíaca demonstrou ter confiabilidade, consistência e validade suficientes, apoiando a sua utilização em estudos futuros.

RESUMEN Introducción: Se ha demostrado que la kinesiofobia tiene una influencia negativa sobre el resultado de la reha-bilitación cardiaca y, por consiguiente, es importante en el contexto clínico. Objetivo: El objetivo de este estudio fue traducir, hacer la adaptación cultural y la validación en términos psicométricos de la Escala de Tampa para Kinesio-fobia Cardiaca (TSK-SV Cardiaca) al portugués de Brasil. Métodos: La versión portuguesa se probó en 300 pacientes en rehabilitación cardiaca. Se evaluó la fiabilidad test-retest por el coeficiente de correlación intraclase, la consistencia interna mediante el alfa de Cronbach, y la validez de criterio con respecto a la educación, el ingreso, la duración de la rehabilitación cardiaca y el sexo de los pacientes. Resultados: Después del análisis de coeficientes de correlación intraclase, un elemento ha sido eliminado. Las cuatro áreas se consideraron internamente consistentes (α > 0,7). Las diferencias significativas entre las puntuaciones totales medias y el ingreso (p < 0,01) apoyaron la validez del criterio. Doscientos sesenta y nueve (89,6%) pacientes tenían un alto nivel de kinesiofobia (puntuación > 37). Conclusiones: La versión en portugués de Brasil de la TSK-SV Cardiaca ha demostrado suficiente fiabilidad, consistencia y validez, apoyando su uso en futuros estudios.

Effects of comprehensive cardiac rehabilitation on functional capacity and cardiovascular risk factors in Brazilians assisted by public health care: protocol for a randomized controlled trial

ABSTRACT Background Cardiovascular Disease (CVD) is the leading burden of disease worldwide. Moreover, CVD-related death rates are considered an epidemic in low- and middle-income countries (LMICs). Research shows that cardiac rehabilitation (CR) participation reduces death and improves disability and quality of life. Given the growing epidemic of CVD in LMICs and the insufficient evidence about CR programs in these countries, a Randomized Control Trial (RCT) in Latin America is warranted. Objective To investigate the effects of comprehensive CR on functional capacity and cardiovascular risk factors. Method The design is a single-blinded RCT with three parallel arms: comprehensive CR (exercise + education) versus exercise-based CR versus wait-list control (no CR). The primary outcome will be measured by the Incremental Shuttle Walk Test. Secondary outcomes are risk factors (blood pressure, dyslipidemia, dysglycemia, body mass index and waist circumference); tertiary outcomes are heart health behaviors (exercise, medication adherence, diet, and smoking), knowledge, and depressive symptoms. The CR program is six months in duration. Participants randomized to exercise-based CR will receive 24 weeks of exercise classes. The comprehensive CR group will also receive 24 educational sessions, including a workbook. Every outcome will be assessed at baseline and 6-months later, and mortality will be ascertained at six months and one year. Conclusion This will be the first RCT to establish the effects of CR in Latin America. If positive, results will be used to promote broader implementation of comprehensive CR and patient access in the region and to inform a larger-scale trial powered for mortality.