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.

FUNDAMENTO: As doenças cardiovasculares possuem alta incidência e prevalência no Brasil, porém a participação na Reabilitação Cardíaca (RC) é limitada e pouco investigada no país. A Escala de Barreiras para Reabilitação Cardíaca (CRBS) foi desenvolvida para avaliar as barreiras à participação e aderência à RC. OBJETIVO: Traduzir, adaptar culturalmente e validar psicometricamente a CRBS para a língua portuguesa do Brasil. MÉTODOS: Duas traduções iniciais independentes foram realizadas. Após a tradução reversa, ambas versões foram revisadas por um comitê. A versão gerada foi testada em 173 pacientes com doença arterial coronariana (48 mulheres, idade média = 63 anos). Desses, 139 (80,3%) participantes de RC. A consistência interna foi avaliada pelo alfa de Cronbach, a confiabilidade teste-reteste pelo coeficiente de correlação intraclasse (ICC) e a validade de construto por análise fatorial. Testes-T foram utilizados para avaliar a validade de critério entre participantes e não participantes de RC. Os resultados da aplicação em função das características dos pacientes (gênero, idade, estado de saúde e grau de escolaridade) foram avaliados. RESULTADOS: A versão em português da CRBS apresentou alfa de Cronbach de 0,88, ICC de 0,68 e revelou cinco fatores, cuja maioria apresentou-se internamente consistente e todos definidos pelos itens. O escore médio para pacientes em RC foi 1,29 (desvio padrão = 0,27) e para pacientes do ambulatório 2,36 (desvio padrão = 0,50) (p < 0,001). A validade de critério foi apoiada também por diferenças significativas nos escores totais por sexo, idade e nível educacional. CONCLUSÃO: A versão em português da CRBS apresenta validade e confiabilidade adequadas, apoiando sua utilização em estudos futuros.

BACKGROUND: Cardiovascular diseases show high incidence and prevalence in Brazil; however, participation in Cardiac Rehabilitation (CR) is limited and has been poorly investigated in the country. The Cardiac Rehabilitation Barriers Scale (CRBS) was developed to assess the barriers to participation and adherence to CR. OBJECTIVE: To translate, cross-culturally adapt and psychometrically validate CRBS to Brazilian Portuguese. METHODS: Two independent initial translations were performed. After the reverse translation, both versions were reviewed by a committee. The new version was tested in 173 patients with coronary artery disease (48 women, mean age = 63 years). Of these, 139 (80.3%) participated in CR. Internal consistency was assessed by Cronbach's alpha, test-retest reliability by intraclass correlation coefficient (ICC) and construct validity by factor analysis. T-tests were used to assess criterion validity between participants and non-participants in CR. The applied test results were evaluated regarding patient characteristics (gender, age, health status and educational level). RESULTS: The Brazilian Portuguese version of the CRBS had Cronbach's alpha of 0.88, ICC of 0.68 and disclosed five factors, most of which showed to be internally consistent and all were defined by the items. The mean score for patients in CR was 1.29 (SD = 0.27) and 2.36 for ambulatory patients (SD = 0.50) (p <0.001). Criterion validity was also supported by significant differences in total scores by gender, age and educational level. CONCLUSION: The Brazilian Portuguese version of CRBS has shown adequate validity and reliability, which supports its use in future studies.