Methodological rigor and quality of reporting of clinical trials published with physical activity interventions: A report from the Strengthening the Evidence in Exercise Sciences Initiative (SEES Initiative).

BACKGROUND: This study addresses the need for improved transparency and reproducibility in randomized clinical trials (RCTs) within the field of physical activity (PA) interventions. Despite efforts to promote these practices, there is limited evidence on the adherence to established reporting and methodological standards in published RCTs. The research, part of the Strengthening the Evidence in Exercise Sciences Initiative (SEES Initiative) in 2020, assessed the methodological standards and reporting quality of RCTs focusing on PA interventions. METHODS: RCTs of PA advice or exercise interventions published in 2020 were selected. Monthly searches were conducted on PubMed/MEDLINE targeting six top-tier exercise science journals. Assessments were conducted by two independent authors, based on 44 items originally from CONSORT and TIDieR reporting guidelines. These items were divided into seven domains: transparency, completeness, participants, intervention, rigor methodology, outcomes and critical analysis. Descriptive analysis was performed using absolute and relative frequencies, and exploratory analysis was done by comparing proportions using the χ2 test (α = 0.05). RESULTS: Out of 1,766 RCTs evaluated for eligibility, 53 were included. The median adherence to recommended items across the studies was 30 (18-44) items in individual assessments. Notably, items demonstrating full adherence were related to intervention description, justification, outcome measurement, effect sizes, and statistical analysis. Conversely, the least reported item pertained to mentioning unplanned modifications during trials, appearing in only 11.3% of studies. Among the 53 RCTs, 67.9% reported having a registration, and these registered studies showed higher adherence to assessed items compared to non-registered ones. CONCLUSIONS: In summary, while critical analysis aspects were more comprehensively described, aspects associated with transparency, such as protocol registrations/modifications and intervention descriptions, were reported suboptimally. The findings underscore the importance of promoting resources related to reporting quality and transparent research practices for investigators and editors in the exercise sciences discipline.

The Development of the Municipal Registry of People with Diabetes in Porto Alegre, Brazil.

Background/Objective: Diabetes registries that enhance surveillance and improve medical care are uncommon in low- and middle-income countries, where most of the diabetes burden lies. We aimed to describe the methodological and technical aspects adopted in the development of a municipal registry of people with diabetes using local and national Brazilian National Health System databases. Methods: We obtained data between July 2018 and June 2021 based on eight databases covering primary care, specialty and emergency consultations, medication dispensing, outpatient exam management, hospitalizations, and deaths. We identified diabetes using the International Classification of Disease (ICD), International Classification of Primary Care (ICPC), medications for diabetes, hospital codes for the treatment of diabetes complications, and exams for diabetes management. Results: After data processing and database merging using deterministic and probabilistic linkage, we identified 73,185 people with diabetes. Considering that 1.33 million people live in Porto Alegre, the registry captured 5.5% of the population. Conclusions: With additional data processing, the registry can reveal information on the treatment and outcomes of people with diabetes who are receiving publicly financed care in Porto Alegre. It will provide metrics for epidemiologic surveillance, such as the incidence, prevalence, rates, and trends of complications and causes of mortality; identify inadequacies; and provide information. It will enable healthcare providers to monitor the quality of care, identify inadequacies, and provide feedback as needed.

Impact of exergames on bmi and cardiovascular risk factors: a systematic review / Impacto de exergames sobre imc y los factores de riesgo cardiovascular: revisión sistemática / Impacto de exergames no imc e fatores de risco cardiovascular: uma revisão sistemática

ABSTRACT Introduction: Exergames or active video games are digital platforms with functionality associated with body movement, which dialogue with improving physical activity levels, stimulating pleasure in practice and adherence to change habits, physically active behavior, and better quality of life. Objective: This study aimed to synthesize the available evidence on the contribution of exergame to Body Mass Index, physical activity level, glycemic control, blood pressure, and cardiorespiratory fitness in adolescents. Methods: This is a systematic review, reported following the PRISMA writing recommendations, without language restrictions, for articles indexed in the following databases: MEDLINE / PubMed, Embase, Cochrane Library, and Lilacs. Data extraction was performed analogously in a spreadsheet previously tested and standardized. The assessment of the risk of bias in the included studies was carried out by the RoB 1.0 tool in all of its domains in duplicate of reviewers. Initially, 3.039 studies were found. Results: The studies cover a total of 526 adolescents aged ten to 19. The most used platform in the studies was the Nintendo Wii, followed by the PlayStation, Xbox 360, and Dance Dance Revolution. The results indicated that interventions using exergames were effective for changing BMI, but there was no evidence on cardiovascular outcomes, with no effective changes in glycemic control and blood pressure and a significant response (p <0.05) in cardiorespiratory fitness. Conclusion: The exergame points to satisfactory results in improving health and can be incorporated as a relevant public policy in the adolescent health promotion. (PROSPERO Registration CRD42020181772). Level of evidence II; Therapeutic studies - investigation of treatment results.

RESUMEN Introducción: Los Exergames o videojuegos activos son plataformas digitales con funcionalidad asociada al movimiento corporal, que dialogan con la mejora de los niveles de actividad física, estimulando el placer en la práctica y la adherencia a cambios de hábitos, conducta físicamente activa y mejor calidad de vida. Objetivo: Este estudio tuvo como objetivo sintetizar la evidencia disponible sobre la contribución del exergame al índice de masa corporal, nivel de actividad física, control glucémico, presión arterial y aptitud cardiorrespiratoria en adolescentes. Métodos: Se trata de una revisión sistemática, reportada siguiendo las recomendaciones de redacción de PRISMA, sin restricción de idioma, para artículos indexados en las siguientes bases de datos: MEDLINE / PubMed, Embase, Cochrane Library y Lilacs. La extracción de datos se realizó de manera similar en una hoja de cálculo estandarizada y probada previamente. La evaluación del riesgo de sesgo en los estudios incluidos se realizó mediante la herramienta RoB 1.0 en todos sus dominios por duplicado de revisores. Inicialmente, se encontraron 3.039 estudios. Resultados: Los estudios abarcaron un total de 526 adolescentes de 10 a 19 años. La plataforma más utilizada en estudios fue la Nintendo Wii, seguida de la PlayStation, Xbox 360 y Dance Dance Revolution. Los resultados indicaron que las intervenciones con exergames fueron efectivas para cambiar el IMC, pero no hubo evidencia sobre los resultados cardiovasculares, no hubo cambios efectivos en el control glucémico y la presión arterial, y una respuesta explicativa (p <0.05) en la aptitud cardiorrespiratoria. Conclusión: El exergame muestra resultados satisfactorios en la mejora de la salud y puede ser incorporado como una política pública relevante en la promoción de la salud de los adolescentes. (Registro PROSPERO CRD42020181772). Nivel de evidencia II; Estudios terapéuticos: investigación de los resultados del tratamiento.

RESUMO Introdução: Exergames ou vídeo games ativos são plataformas digitais com funcionalidade associada ao movimento corporal, que dialogam com a melhora dos níveis de atividade física, estimulando o prazer na prática e a adesão à mudança de hábitos, comportamento ativo e melhor qualidade de vida. Objetivo: Este estudo teve como objetivo sintetizar as evidências disponíveis sobre a contribuição do exergame para o Índice de Massa Corporal, nível de atividade física, controle glicêmico, pressão arterial e aptidão cardiorrespiratória em adolescentes. Métodos: Trata-se de uma revisão sistemática, relatada seguindo as recomendações de redação do PRISMA, sem restrição de idioma, para artigos indexados nas seguintes bases de dados: MEDLINE / PubMed, Embase, Cochrane Library e Lilacs. A extração dos dados foi realizada de forma análoga em planilha previamente testada e padronizada. A avaliação do risco de viés nos estudos incluídos foi realizada pela ferramenta RoB 1.0 em todos os seus domínios em duplicata de revisores. Inicialmente, foram encontrados 3.039 estudos. Resultados: Os estudos abrangeram um total de 526 adolescentes de dez a 19 anos. A plataforma mais utilizada nos estudos foi o Nintendo Wii, seguido do PlayStation, Xbox 360 e Dance Dance Revolution. Os resultados indicaram que as intervenções com exergames foram eficazes para alterar o IMC, mas não houve evidências sobre os desfechos cardiovasculares, sem alterações eficazes no controle glicêmico e na pressão arterial e uma resposta significativa (p <0,05) na aptidão cardiorrespiratória. Conclusão: O exergame aponta resultados satisfatórios na melhoria da saúde e pode ser incorporado como uma política pública relevante na promoção da saúde do adolescente. (Registro PROSPERO CRD42020181772). Nível de evidência II; Estudos terapêuticos: investigação dos resultados do tratamento.

Análise da situação de saúde dos idosos usuários de uma política municipal de atividades físicas / Analysis of health status of older adults users of a municipal physical activity program / Análisis de la situación de salud de los adultos ancianos de una política municipal de actividad física

Introdução: Políticas públicas intersetoriais em saúde são intervenções populacionais (e de cunho ecológico) muito utilizadas para a redução da carga global de doença e otimização de recursos tanto financeiros quanto humanos. Objetivo: O objetivo deste estudo foi analisar a situação de saúde de usuários idosos de uma política municipal de atividades físicas. Métodos: Trata-se de um estudo transversal com amostragem baseada em centros comunitários (N dispositivos comunitários=11), que disponibilizam práticas de movimentos corporais e outros, subsidiados pela Secretaria Municipal de Desenvolvimento Social e Esporte (SMDSE), Prefeitura Municipal de Porto Alegre (RS). A amostragem de usuários foi ponderada para o total de usuários atendidos por centro, adotando seleção aleatória simples. A coleta de dados ocorreu entre abril de 2018 e fevereiro de 2019, em que a equipe de coleta se deslocou ao território adscrito dos usuários para a condução de inquérito de saúde autoaplicado e a avaliação funcional; de forma contrária, os usuários compareceram a um centro de coleta para a série laboratorial (sem jejum). Resultados: Foram incluídos e analisados 351 usuários (média±desvio padrão, 70±6 anos). Para fatores de risco cardiovasculares, a prevalência de hipercolesterolemia foi de 54,2% e de 49,3% para hipertensão arterial sistêmica ­ as mais elevadas. O transtorno de sono foi prevalente em 55,3% da amostra. Entre as doenças autorrelatadas, os participantes listaram as cardiovasculares (14,3%), câncer prévio (14,6%), diabetes (13,2%), artrite reumatoide/ reumatismo (29,6%) e depressão (sem discriminador de depressão maior/ menor) (18,6%). A capacidade funcional, estimada pelo teste de caminhada em 6 minutos e a força de preensão manual, preditores de mortalidade cardiovascular e agravos, tiveram valores médios encontrados de 498,05±78,96 m e 27,08±8,14 kg, respectivamente. Conclusão: Os achados do presente estudo permitem contrastar prevalências estimadas em idosos participantes de um programa público de atividades físicas com outras estimativas em grupos de comparação, possibilitando a análise de situação de saúde com base em diferentes comportamentos e fatores de risco. Por fim, o trabalho viabilizou a monitorização de intervenções públicas para idosos em nível comunitário, sendo um ponto de base para acompanhamento futuro.

Introduction: Intersectoral public policies on health are population (and ecological) interventions widely used to reduce the global burden of disease and optimize both financial and human resources. Objective: The objective of this study was to analyze the health status of older adults users of a municipal policy on physical activities. Methods: This is a cross-sectional study with a sample based on community centers (N community centers=11), which provide body movement practices and others, funded by the Municipal Department of Social Development and Sports (SMDSE), City Hall of Porto Alegre (state of Rio Grande do Sul ­ RS, Brazil). The users' sample was weighted by the number of users of each center, by simple random sampling. Data collection took place between April 2018 and February 2019, in which the collection team went to the users' assigned territory to conduct a self-administered health survey and functional assessment; conversely, the users attended a collection center for laboratory tests (without fasting). Results: A total of 351 users (mean±SD, 70±6 years old) were included. For cardiovascular risk factors, the prevalence of hypercholesterolemia was 54.2% and 49.3% for systemic arterial hypertension ­ the highest levels. Sleep disorder was prevalent in 55.3% of the sample. Among the self-reported diseases, participants listed cardiovascular (14.3%), previous cancer (14.6%), diabetes (13.2%), rheumatoid arthritis/rheumatism (29.6%), and depression (without major/minor depression discrimination) (18.6%). Functional capacity, estimated by the six-minute walk test, and handgrip strength, predictors of cardiovascular mortality and injuries, had mean values of 498.05±78.96 m and 27.08±8.14 kg, respectively. Conclusions: The findings of this study allow contrasting prevalence rates estimated in older adults participants of a public physical activity program with other estimates in comparison groups, enabling the analysis of health status based on different behaviors and risk factors. All in all, our study enabled to monitor public interventions for older adults at the community level, serving as a baseline for future monitoring.

Introducción: Las políticas de salud pública intersectoriales tienen el potencial de destacar la reducción de la carga global de enfermedad y la optimización de los recursos financieros y humanos. Objetivo: El objetivo de este estudio fue analizar la situación de salud de los usuarios, ancianos, de una política municipal de actividades físicas. Métodos: Se trata de un estudio transversal con muestreo a partir de centros comunitarios (N dispositivos comunitarios=11), que brindan prácticas de movimiento corporal y otras, subsidiadas por la Secretaria Municipal de Desenvolvimento Social e Esporte (SMDSE), Prefeitura Municipal de Porto Alegre (RS). El muestreo de usuarios fue ponderado por el total de usuarios atendidos por centro, adoptando selección aleatoria simple. La recolección de datos ocurrió entre abril/2018 y febrero/2019, cuando el equipo de recolección viajó al territorio asignado de los usuarios para realizar una encuesta de salud auto aplicada y evaluación funcional; por el contrario, los usuarios acudían a un centro de recogida de series de laboratorio (sin ayuno). Resultados: Se incluyeron y analizaron 351 usuarios (media±DP, 70±6 años). Para los factores de riesgo cardiovascular, la prevalencia de hipercolesterolemia fue de 54,2% y de hipertensión arterial sistémica de 49,3%, la más alta. El trastorno del sueño fue prevalente en el 55,3% de la muestra. Entre las enfermedades auto informadas, los participantes enumeraron enfermedades cardiovasculares (14,3%), cáncer previo (14,6%), diabetes (13,2%), artritis reumatoide/reumatismo (29,6%) y depresión (sin discriminación de depresión mayor/menor) (18,6%). La capacidad funcional, estimada por la prueba de la marcha de 6 minutos, y la fuerza de prensión manual, predictores de mortalidad y lesiones cardiovasculares, tuvieron valores medios de 498,05±78,96 m y 27,08±8,14 kg, respectivamente. Conclusiones: Los hallazgos de este estudio permiten contrastar las prevalencias estimadas en participantes ancianos de un programa público de actividades físicas con otras estimaciones en grupos de comparación, lo que permite el análisis de la situación de salud basado en diferentes comportamientos y factores de riesgo. Por último, el trabajo ha facilitado la monitorización de intervenciones públicas para personas mayores a nivel comunitario, sirviendo como punto de partida para un seguimiento futuro.

Hemostasis control after femoral percutaneous approach: A systematic review and meta-analysis.

BACKGROUND: Hemostasis control after percutaneous endovascular procedures through the femoral approach remains challenging for catheterization laboratory nurses, given method variability. OBJECTIVE: To summarize the available evidence on vascular devices efficacy dedicated to hemostasis control compared to the extrinsic compression after percutaneous procedures in the femoral vein or artery. METHODS: A systematic review with meta-analysis of randomized clinical trials was conducted. We compared different hemostasis methods in adult patients who underwent diagnostic and/or therapeutic procedures through femoral access. The databases searched were PubMed, Embase, CINAHL and Cochrane CENTRAL, and updated on 03/2022. The outcomes included hematoma, pseudoaneurysm, bleeding, minor and major vascular complication, time to hemostasis, device failure, and manual compression repetition. The risk of bias was assessed using the Cochrane Risk of Bias Tool 1.0. Pooled effect sizes on continuous, categorical and proportion variables were estimated with the random effects model. The continuous variables were summarized as the difference between means weighted by the inverse of variance (WMD), and the categorical ones by the summary of relative risks (RR), estimated by the DerSimonian and Laird method. The Freeman-Tukey method was used to estimate the summary effect of proportions. RESULTS: Fifty articles were included in the systematic review. When compared to extrinsic compression, vascular closure devices resulted in a relative risk reduction (RRR) for hematoma: RR 0.82 [95%CI 0.72 to 0.94] and in shorter time to hemostasis WMD -15.06 min [95%CI -17.56 to -12.56]; no association was observed between interventions with vascular closure devices and extrinsic compression for pseudoaneurysm, bleeding, minor and major vascular complications. Compared to extrinsic compression, sealant or gel type devices were compatible with a RRR for hematoma: RR 0.73 [95%CI 0.59 to 0.90]; and metal clip or staple type devices for pseudoaneurysm: RR 0.48 [95%CI 0.25 to 0.90]; and major vascular complication: RR 0.33 [95%CI 0.17 to 0.64]. For each 100 observations, the device failure rate for metal clip or staple was 3.28% [95%CI 1.69 to 6.27]; for suture 6.84% [95%CI 4.93 to 9.41]; for collagen 3.15% [95%CI 2.24 to 4.41]; and for sealant or gel 7.22% [95% CI 5.49 to 9.45]. CONCLUSIONS: Vascular closure devices performed better in hemostasis control. The certainty of the evidence was rated as very low to moderate. REGISTRATION: PROSPERO CRD42019140794.

Correlates of functional physical capacity in physically active older adults: a conceptual-framework-based cross-sectional analysis of social determinants of health and clinical parameters.

BACKGROUND: Functional decline in older adults may be affected by clinical status, physical fitness, and social determinants of health. AIMS: This study aimed to explore social determinants of health and health/clinical determinants on two outcomes of functional physical capacity. METHODS AND RESULTS: Therefore, a population-based sample of 327 older adults (69 ± 7 years; 83.5% women) underwent demographical and clinical questionnaires, risk factors assessments, 6-min walk testing (walking capacity), and handgrip strength testing. Based on multivariable linear regression models, age ( - 4.05 m; - 5.3 to - 2.8), being men (71.40 m; 50.5-92.3), body mass index ( - 3.88 m; - 5.6 to - 2.1), and quality of life (18.48 m; 6.3-30.6) remained as predictive variables for walking capacity (R2 = 30.8%). In the final model for handgrip strength, age ( - 0.6% kgf; 0.89-0.2) and male sex (65.2% kgf; 55.3-75.8) remained as predictive variables. DISCUSSION: The mean values for our predicted outcomes were similar to those of healthy and physically active ones, which may be a consequence of the engagement of our sample in a lifestyle program. Also, although using the conceptual framework model to choose explanatory variables with a solid rationale, some of them may present reverse causality in this study setting, regardless of our efforts to annulate this type of bias. CONCLUSIONS: Despite exploratory analyses including contextual factors as potential predictors of walking capacity and handgrip strength, only outcomes at the individual levels were associated, either positively or negatively, with the variations presented by this studied sample of older adults.

Thiazide diuretics alone or in combination with a potassium-sparing diuretic on blood pressure-lowering in patients with primary hypertension: protocol for a systematic review and network meta-analysis.

BACKGROUND: The use of thiazide (T) diuretics for the treatment of hypertension may be associated with adverse metabolic effects, which can be minimized by combining thiazides with potassium-sparing (PS) diuretics. The additional blood pressure (BP)-lowering effect provided by the addition of a PS diuretic is unclear. Due to a large number of drugs in the T diuretics class, and the possible difference between them, there is a need to identify the best available evidence for health decision-making. This systematic review with network meta-analysis aims to compare the antihypertensive efficacy of T diuretics alone or in combination with a PS diuretic in patients with primary hypertension, as well as the safety of such drugs through the measurement of drug-related adverse events. METHODS: A comprehensive electronic search will be conducted in six electronic bibliographic databases (PubMed/MEDLINE, Cochrane Library, Embase, Web of Science, Scopus, Lilacs), a registration database ( ClinicalTrials.gov ), and Educational Resources Information Center (ERIC [ProQuest]), published from inception to the date of the search. The search will be updated towards the end of the review. A hand search of the reference sections of the included studies and cited studies will also be performed. In case of missing data, authors will be contacted by e-mail or academic social networking sites whenever possible. To be included in the review, studies must be double-blind randomized controlled trials evaluating T diuretics alone or in combination with PS diuretics in patients with primary hypertension. The primary outcome measure will be office BP. Ambulatory BP monitoring (ABPM), non-melanoma skin cancer, major adverse cardiovascular events, laboratory parameters, and the number of withdrawals will be included as secondary outcomes. The results will be quantitatively summarized using differences between the mean change from baseline or differences between means for quantitative outcomes and relative risk for dichotomous outcomes. Results will be presented as mean or relative risk with credible intervals through a league table. The treatments will also be ranked using the surface under the cumulative ranking curve method. The risk of bias will be assessed through the RoB 1.0 tool. DISCUSSION: To the best of our knowledge, this review will be the first to synthesize currently available evidence on the antihypertensive efficacy of different T diuretics alone or in combination with PS diuretics in adults with hypertension. The goals of hypertension treatment are to control high BP and to reduce associated cardiovascular morbidity and mortality, using the most appropriate therapy. Thiazides are widely used for pharmacological treatment due to their demonstrated effectiveness in reducing BP, favorable safety profile, and low cost. The results of this study will provide evidence regarding the best therapeutic strategies with T and PS diuretics, evidencing interventions with better antihypertensive efficacy and safety profile. TRIAL REGISTRATION: This systematic review and network meta-analysis was prospectively registered at the PROSPERO database ( CRD42018118492 ).

Systematic reviews on the success of dental implants present low spin of information but may be better reported and interpreted: An overview of systematic reviews with meta-analysis.

OBJECTIVE: To estimate the prevalence of spin and completeness of reporting of systematic reviews with metanalysis (SRMAs) in implant dentistry. STUDY DESIGN AND SETTING: Inclusion criteria were SRMAs of randomized clinical trials of implant dentistry on survival, success, or failure rates in humans, with no language restriction. Three databases were searched from inception to May 2021. Main outcomes were prevalence of spin (primary outcome) and completeness of reporting (secondary outcome) in abstracts and full texts. RESULTS: We identified 2481 SRMAs and 45 unique manuscripts were included. There was a low presence of spin in the abstracts and full text, except for adverse events, in which 51.1% (in the abstract) failed to mention any adverse event for summarized interventions. There was an adequate report of SRMAs in the full text except for prospective register (33.3% not reported). However, there was an incomplete report for most items in the abstract considering PRISMA-A checklist. CONCLUSION: In general, the included SRMAs presented a (a) low prevalence of spin (except for adverse events in the abstract); (b) adequate completeness of reporting in the full text (except for prospective register); and (c) incomplete report for most items in the abstracts.

Percepção dos usuários sobre a atenção primária em saúde: estudo transversal em um município de grande porte / Users' perception about primary health care: a cross-sectional study in a large municipality

O objetivo deste estudo foi avaliar o nível de satisfação dos usuários da Atenção Primária em Saúde de um município de grande porte. Trata-se de um estudo transversal, do tipo censitário e com amostra por conveniência, visto que foram incluídas todas as unidades de saúde e entrevistados os usuários que estavam na sala de espera no dia da coleta e aceitaram participar da pesquisa. Toda a coleta de dados foi realizada por meio de questionários, e,posteriormente,tabulada e analisada no software Stata 14.0. Os usuários relataram satisfação com a unidade e equipe, e com serviços assistenciais. Entretanto, usuários que manifestaram que trocariam de unidade caso isto fosse possível, tinham razões atribuídas à organização do cuidado e agendamento de consultas. Concluímos que a satisfação com os cuidados exercidos pelos profissionais e com o acolhimento de informações de cunho afetivo foram evidentemente altas, ao passo que a insatisfação com a organização do cuidado é aparente.

This study aimed to assess the level of satisfaction of users of PrimaryHealth Care in a large city. This is a cross-sectional, census-type study with a convenience sample, as all health units were included and users who were in the waiting room on the day of collection and who agreed to participate in the survey were interviewed. All data collection was performed through questionnaires, and later tabulated and analyzed using the Stata 14.0 software. Users reported satisfaction with the unit and team, and with care services. However, users who stated that they would change units if this was possible had reasons attributed to the organization of care and appointment scheduling. We conclude that satisfaction with the care provided by professionals and with the reception of information of an affective nature were evidently high, while dissatisfaction with the organization of care is apparent.

Effects of a power strength training using elastic resistance exercises on the motor and non-motor symptoms in patients with Parkinson's disease H&Y 1-3: study protocol for a randomised controlled trial (PARK-BAND Study).

INTRODUCTION: Parkinson's disease (PD) is the second most common neurodegenerative disorder in Brazil. Physical activity is a complementary intervention in managing inherent declines associated with the disease like strength, balance, gait, and functionality and benefit health-related outcomes. Here, we report the PARK-BAND Study protocol, which aims to investigate potential benefits of power training using elastic devices in participants with PD. Our intervention will be provided in patients with PD using elastic devices like elastic bands and tubes. Therefore, we used the term Park from Parkinson's disease and band from elastic bands. METHODS AND ANALYSIS: This randomised single-blind single-centre two-arm parallel, superiority trial will include 50 participants with PD attending the clinical setting. Those who meet the eligibility criteria and provide consent to participate will be randomised in a 1:1 ratio to either the exercise group, which will receive power training programme or the health education group, which will receive the education programme. Randomisation will be performed by permuted block randomisation with a block size of eight. Both groups will receive a 12-week intervention. The exercise group will have two sessions per week and the health education group will have one session per week. Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes. Secondary outcomes include other neurological, neurophysiological and physical variables, as well as the quality of life, depression, cognition, sleep quality and disturbances, assessed before and after interventions. We hypothesise that the exercise group will have greater improvement in primary and secondary outcomes than the health education group. ETHICS AND DISSEMINATION: The study is approved by the Research Ethics Committee of Hospital Universitário Walter Cantidio and all participants will provide their written informed consent (register number 91075318.1.0000.5045).Trial results will be disseminated via peer reviewed journal articles and conference presentations, reports for organisations involved with PD and for participants. TRIAL REGISTRATION NUMBER: Registro Brasileiro de Ensaios Clínicos Registry (RBR-5w2sqt); Pre-results.

Intradialytic training in patients with end-stage renal disease: a systematic review and meta-analysis of randomized clinical trials assessing the effects of five different training interventions.

OBJECTIVE: Patients with end-stage renal disease (ESRD) undergoing hemodialysis may have reduced dialysis adequacy (Kt/V), low cardiorespiratory fitness, and worse prognosis. Different types of intradialytic training (IDT) may serve as an adjunct therapy for the management of the ESRD. This systematic review and meta-analysis aimed to assess the impact of different types of IDT on clinical outcomes and functional parameters in ESRD. METHODS: PubMed, Embase, CINAHL, Cochrane CENTRAL, Scopus, SPORTDiscus, and Google Scholar were searched for randomized clinical trials in adult patients with ESRD which compared IDT with usual care (UC), without language restrictions and published up to July 2019; a handsearch of references was also performed. Certainty of evidence was assessed using GRADE, and risk of bias in primary studies with the RoB 1.0 tool. RESULTS: Fifty studies were included (n = 1757). Compared to UC, aerobic IDT improved Kt/V (WMD = 0.08), VO2peak (WMD = 2.07 mL/kg/min), 6-minute walk test (6MWT) distance (64.98 m), reduced systolic blood pressure (- 10.07 mmHg) and C-reactive protein (- 3.28 mg/L). Resistance training increased 6MWT distance (68.50 m). Combined training increased VO2peak (5.41 mL/kg/min) and reduced diastolic blood pressure (- 5.76 mmHg). Functional electrostimulation (FES) and inspiratory muscle training (IMT) improved 6MWT distance (54.14 m and 117.62 m, respectively). There was no impact on total cholesterol, interleukin-6, or hemoglobin levels. There was no difference in incidence of adverse events between the IDT and control groups. The certainty of evidence was variable according to the GRADE scale, with most outcomes rated very low certainty. The risk of bias assessment of primary studies showed unclear risk in most. CONCLUSIONS: Aerobic, resistance, and combined training during hemodialysis, as well as FES and IMT, demonstrated to be effective for the treatment of the patient with ESRD. Our data should be interpreted in light of the unclear risk of bias of most evaluated articles and the low to very low certainty of evidence for evaluated outcomes. PROSPERO REGISTRATION ID: CRD42017081338. DATA SHARING REPOSITORY: https://osf.io/fpj54/.

Efficacy of chlorthalidone and hydrochlorothiazide in combination with amiloride in multiple doses on blood pressure in patients with primary hypertension: a protocol for a factorial randomized controlled trial.

BACKGROUND: Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, but the equivalent doses of their more common agents, chlorthalidone and hydrochlorothiazide, are still unclear. Further, concerns exist regarding adverse metabolic effects, which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. This trial aims to investigate the efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride at different doses, for initial management of patients with primary hypertension. METHODS/DESIGN: This is a factorial (2 × 2) randomized double-blinded clinical trial comparing the association of a thiazide diuretic (chlorthalidone 25 mg/day or hydrochlorothiazide 50 mg/day) with a potassium-sparing diuretic (amiloride 10 mg/day or amiloride 20 mg/day) in patients with primary hypertension. The primary outcome will be the mean change from baseline in 24-h systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring. The secondary outcomes will be the mean change from baseline in daytime and nighttime systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring, mean change from baseline in systolic and diastolic blood pressure measured by office blood pressure, incidence of adverse events, variation of laboratory parameters, and proportion of patients who achieved blood pressure control. The follow-up will last 12 weeks. For a P alpha of 0.05, power of 80%, standard deviation of 9 mmHg, and absolute difference of 6 mmHg on systolic blood pressure on 24-h ambulatory blood pressure monitoring, it will be necessary to study a total of 76 patients. The sample size will be increased by 10% to compensate for losses, resulting in 84 patients being randomized. DISCUSSION: Diuretics are pivotal drugs for the treatment of hypertension. Chlorthalidone and hydrochlorothiazide, in combination with amiloride in multiple doses, will be tested in terms of blood pressure lowering efficacy and safety. Since the intensity of blood pressure reduction is the major determinant of reduction in cardiovascular risk in hypertensive patients, this study will help to determine which combination of diuretics represents the most appropriate treatment for this population. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03928145. Registered on 25 April 2019. Last update on 29 April 2019.

Biochemical and Molecular Mechanisms of Glucose Uptake Stimulated by Physical Exercise in Insulin Resistance State: Role of Inflammation / Mecanismos Bioquímicos e Moleculares da Captação da Glicose Estimulada pelo Exercício Físico no Estado de Resistência à Insulina: Papel da Inflamação

Abstract Obesity associated with systemic inflammation induces insulin resistance (IR), with consequent chronic hyperglycemia. A series of reactions are involved in this process, including increased release of proinflammatory cytokines, and activation of c-Jun N-terminal kinase (JNK), nuclear factor-kappa B (NF-κB) and toll-like receptor 4 (TLR4) receptors. Among the therapeutic tools available nowadays, physical exercise (PE) has a known hypoglycemic effect explained by complex molecular mechanisms, including an increase in insulin receptor phosphorylation, in AMP-activated protein kinase (AMPK) activity, in the Ca2+/calmodulin-dependent protein kinase kinase (CaMKK) pathway, with subsequent activation of peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α), Rac1, TBC1 domain family member 1 and 4 (TBC1D1 and TBC1D4), in addition to a variety of signaling molecules, such as GTPases, Rab and soluble N-ethylmaleimide-sensitive factor attached protein receptor (SNARE) proteins. These pathways promote greater translocation of GLUT4 and consequent glucose uptake by the skeletal muscle. Phosphoinositide-dependent kinase (PDK), atypical protein kinase C (aPKC) and some of its isoforms, such as PKC-iota/lambda also seem to play a fundamental role in the transport of glucose. In this sense, the association between autophagy and exercise has also demonstrated a relevant role in the uptake of muscle glucose. Insulin, in turn, uses a phosphoinositide 3-kinase (PI3K)-dependent mechanism, while exercise signal may be triggered by the release of calcium from the sarcoplasmic reticulum. The objective of this review is to describe the main molecular mechanisms of IR and the relationship between PE and glucose uptake.

Resumo A obesidade associada à inflamação sistêmica induz resistência à insulina (RI), com consequente hiperglicemia crônica. Este processo envolve o aumento na liberação de citocinas pró-inflamatórias, ativação da enzima c-Jun N-terminal cinase (JNK), do fator nuclear kappa-B (NF-κB) e dos receptores do tipo Toll 4 (TLR4). Dentre as ferramentas terapêuticas disponíveis, o exercício físico (EF) tem efeito hipoglicemiante conhecido, explicado por mecanismos moleculares complexos. Dentre eles, ocorre aumento na fosforilação do receptor da insulina, na atividade da proteína quinase ativada por AMP (AMPK), na via da proteína cinase cinase dependente de Ca+2/calmodulina (CaMKK), com posterior ativação do coativador-1α do receptor ativado por proliferador do peroxissoma (PGC-1α), proteínas Rac1, TBC1 membro das famílias de domínio 1 e 4 (TBC1D1 e TBC1D4), além de uma variedade de moléculas de sinalização, como as proteínas GTPases, Rab e proteína solúvel de fusão sensível a N-etil-maleimida (SNARE); estas vias promovem maior translocação de transportador de glicose do tipo 4 (GLUT4) e consequente captação de glicose pelo músculo esquelético. A cinase fosfatidilinositol-dependente (PDK), proteína quinase C atípica (aPKC) e algumas das suas isoformas, como a PKC-iota/lambda também parecem desempenhar papel fundamental no transporte de glicose. Nesse sentido, a associação entre autofagia e EF também tem demonstrado papel relevante na captação de glicose muscular. A insulina, por sua vez, utiliza um mecanismo dependente da fosfatidilinositol-3-quinase (PI3K), enquanto que o sinal do EF pode ter início mediante liberação de cálcio pelo retículo sarcoplasmático e concomitante ativação da AMPK. O objetivo desta revisão é descrever os principais mecanismos moleculares da RI e da relação entre o EF e a captação de glicose.

Biochemical and Molecular Mechanisms of Glucose Uptake Stimulated by Physical Exercise in Insulin Resistance State: Role of Inflammation.

Obesity associated with systemic inflammation induces insulin resistance (IR), with consequent chronic hyperglycemia. A series of reactions are involved in this process, including increased release of proinflammatory cytokines, and activation of c-Jun N-terminal kinase (JNK), nuclear factor-kappa B (NF-κB) and toll-like receptor 4 (TLR4) receptors. Among the therapeutic tools available nowadays, physical exercise (PE) has a known hypoglycemic effect explained by complex molecular mechanisms, including an increase in insulin receptor phosphorylation, in AMP-activated protein kinase (AMPK) activity, in the Ca2+/calmodulin-dependent protein kinase kinase (CaMKK) pathway, with subsequent activation of peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α), Rac1, TBC1 domain family member 1 and 4 (TBC1D1 and TBC1D4), in addition to a variety of signaling molecules, such as GTPases, Rab and soluble N-ethylmaleimide-sensitive factor attached protein receptor (SNARE) proteins. These pathways promote greater translocation of GLUT4 and consequent glucose uptake by the skeletal muscle. Phosphoinositide-dependent kinase (PDK), atypical protein kinase C (aPKC) and some of its isoforms, such as PKC-iota/lambda also seem to play a fundamental role in the transport of glucose. In this sense, the association between autophagy and exercise has also demonstrated a relevant role in the uptake of muscle glucose. Insulin, in turn, uses a phosphoinositide 3-kinase (PI3K)-dependent mechanism, while exercise signal may be triggered by the release of calcium from the sarcoplasmic reticulum. The objective of this review is to describe the main molecular mechanisms of IR and the relationship between PE and glucose uptake.

The Olympic Experimental Gymnasium Program and its Association with the Prevalence of Cardiovascular Risk Factors in Adolescents: A Cross-Sectional Study / Programa do Ginásio Experimental Olímpico e sua Associação com a Prevalência de Fatores de Risco Cardiovascular em Adolescentes: Estudo Transversal

Abstract Background: Cardiovascular disease (CVD) is the leading cause of death worldwide. Physical activity (PA) and appropriate diet, if adopted in childhood and adolescence, may reduce the CVD burden in later life. The Olympic Experimental Gymnasium (OEG) project was implemented to increase the PA levels of students by means of regular physical exercise and healthy eating habits. Objectives: To estimate and compare the prevalence of CVD risk factors in OEG schools versus regular schools (RSch) and to examine associations between the school environment and CVD risk factors. Methods: In this cross-sectional study with a comparator group, adolescents aged 12-13 years attending three OEG schools (n = 719) and three RSch (n = 394) were evaluated after one year of the ongoing program to estimate the prevalence of overweight, pre-hypertension/hypertension, altered glycemia, and lipid profile. An α level of 0.05 was set for statistical analysis. Results: RSch students had higher odds to have high blood pressure (OR 1.86, 1.36-2.54) and to be overweight (OR 1.49, 1.13-1.98) than OEG students. Glucose levels were not altered in most cases regardless of school type, and no differences were found in lipid profile. In the sensitivity analysis stratified by gender, girls from RSch were more likely to have high body mass index than boys. Conclusions: Exposure of adolescents to the OEG policies was positively associated with an important reduction in CVD risk factors, including high blood pressure and overweight.

Resumo Fundamento: A doença cardiovascular (DCV) é a principal causa de morte em todo o mundo. A atividade física (AF) e uma dieta adequada, quando adotadas na infância e na adolescência, podem reduzir a carga da DCV na fase adulta. O projeto "Ginásio Experimental Olímpico (GEO)" foi implementado para aumentar os níveis de AF dos estudantes por meio de AF regular e hábitos alimentares saudáveis. Objetivos: estimar e comparar a prevalência dos fatores de risco para DCV em GEOs versus escolas regulares (ERs), e avaliar associações entre o meio escolar e os fatores de risco cardiovascular. Métodos: Neste estudo transversal que incluiu um grupo de comparação, estudantes com idade entre 12 e 13 anos de três GEOs (n = 719) e três ERs (n = 394) foram avaliados após um ano de participação no programa para estimar a prevalência de sobrepeso, pré-hipertensão/hipertensão, e de glicemia e perfil lipídico alterados. Um α de 0,05 foi usado para inferências estatísticas. Resultados: Estudantes de ERs apresentaram maior chance de serem hipertensos (OR 1,86; 1,36-2,54) e apresentarem sobrepeso (OR 1,49; 1,13-1,98) que estudantes de GEOs. A glicemia não estava alterada na maioria dos casos, independentemente do tipo da escola, e não houve diferenças quanto ao perfil lipídico. Na análise de sensibilidade estratificada por gênero, estudantes do sexo feminino das ERs apresentaram maior probabilidade de apresentarem índice de massa corporal elevado que os do sexo masculino. Conclusão: A exposição dos adolescentes às políticas adotadas pelos GEOs associou-se positivamente com uma importante redução nos fatores de risco para DCV, incluindo hipertensão e sobrepeso.

The "Hypertension Approaches in the Elderly: a Lifestyle study" multicenter, randomized trial (HAEL Study): rationale and methodological protocol.

BACKGROUND: Hypertension is a clinical condition highly prevalent in the elderly, imposing great risks to cardiovascular diseases and loss of quality of life. Current guidelines emphasize the importance of nonpharmacological strategies as a first-line approach to lower blood pressure. Exercise is an efficient lifestyle tool that can benefit a myriad of health-related outcomes, including blood pressure control, in older adults. We herein report the protocol of the HAEL Study, which aims to evaluate the efficacy of a pragmatic combined exercise training compared with a health education program on ambulatory blood pressure and other health-related outcomes in older individuals. METHODS: Randomized, single-blinded, multicenter, two-arm, parallel, superiority trial. A total of 184 subjects (92/center), ≥60 years of age, with no recent history of cardiovascular events, will be randomized on a 1:1 ratio to 12-week interventions consisting either of a combined exercise (aerobic and strength) training, three times per week, or an active-control group receiving health education intervention, once a week. Ambulatory (primary outcome) and office blood pressures, cardiorespiratory fitness and endothelial function, together with quality of life, functional fitness and autonomic control will be measured in before and after intervention. DISCUSSION: Our conceptual hypothesis is that combined training intervention will reduce ambulatory blood pressure in comparison with health education group. Using a superiority framework, analysis plan prespecifies an intention-to-treat approach, per protocol criteria, subgroups analysis, and handling of missing data. The trial is recruiting since September 2017. Finally, this study was designed to adhere to data sharing practices. TRIAL REGISTRATION: NCT03264443 . Registered on 29 August, 2017.

The Olympic Experimental Gymnasium Program and its Association with the Prevalence of Cardiovascular Risk Factors in Adolescents: A Cross-Sectional Study.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death worldwide. Physical activity (PA) and appropriate diet, if adopted in childhood and adolescence, may reduce the CVD burden in later life. The Olympic Experimental Gymnasium (OEG) project was implemented to increase the PA levels of students by means of regular physical exercise and healthy eating habits. OBJECTIVES: To estimate and compare the prevalence of CVD risk factors in OEG schools versus regular schools (RSch) and to examine associations between the school environment and CVD risk factors. METHODS: In this cross-sectional study with a comparator group, adolescents aged 12-13 years attending three OEG schools (n = 719) and three RSch (n = 394) were evaluated after one year of the ongoing program to estimate the prevalence of overweight, pre-hypertension/hypertension, altered glycemia, and lipid profile. An α level of 0.05 was set for statistical analysis. RESULTS: RSch students had higher odds to have high blood pressure (OR 1.86, 1.36-2.54) and to be overweight (OR 1.49, 1.13-1.98) than OEG students. Glucose levels were not altered in most cases regardless of school type, and no differences were found in lipid profile. In the sensitivity analysis stratified by gender, girls from RSch were more likely to have high body mass index than boys. CONCLUSIONS: Exposure of adolescents to the OEG policies was positively associated with an important reduction in CVD risk factors, including high blood pressure and overweight.