The Brazilian national prospective active surveillance (AS) cohort of patients with low-risk prostate cancer in the public health system: vigiaSUS study protocol.

BACKGROUND: Prostate cancer exhibits a very diverse behaviour, with some patients dying from the disease and others never needing treatment. Active surveillance (AS) consists of periodic PSA assessment (prostate-specific antigen), DRE (digital rectal examination) and periodic prostate biopsies. According to the main guidelines, AS is the preferred strategy for low-risk patients, to avoid or delay definitive treatment. However, concerns remain regarding its applicability in certain patient subgroups, such as African American men, who were underrepresented in the main cohorts. Brazil has a very racially diverse population, with 56.1% self-reporting as brown or black. The aim of this study is to evaluate and validate the AS strategy in low-risk prostate cancer patients following an AS protocol in the Brazilian public health system. METHODS: This is a multicentre AS prospective cohort study that will include 200 patients from all regions of Brazil in the public health system. Patients with prostate adenocarcinoma and low-risk criteria, defined as clinical staging T1-T2a, Gleason score ≤ 6, and PSA < 10 ng/ml, will be enrolled. Archival prostate cancer tissue will be centrally reviewed. Patients enrolled in the study will follow the AS strategy, which involves PSA and physical examination every 6 months as well as multiparametric MRI (mpMRI) every two years and prostate biopsy at month 12 and then every two years. The primary objective is to evaluate the reclassification rate at 12 months, and secondary objectives include determining the treatment-free survival rate, metastasis-free survival, and specific and overall survival. Exploratory objectives include the evaluation of quality of life and anxiety, the impact of PTEN loss and the economic impact of AS on the Brazilian public health system. DISCUSSION: This is the first Brazilian prospective study of patients with low-risk prostate cancer under AS. To our knowledge, this is one of the largest AS study cohort with a majority of nonwhite patients. We believe that this study is an opportunity to better understand the outcomes of AS in populations underrepresented in studies. Based on these data, an AS national clinical guideline will be developed, which may have a beneficial impact on the quality of life of patients and on public health. TRIAL REGISTRATION: Clinicaltrials registration is NCT05343936.

Association of physical activity levels and the prevalence of COVID-19-associated hospitalization.

OBJECTIVES: We compared physical activity levels before the outbreak and quarantine measures with COVID-19-associated hospitalization prevalence in surviving patients infected with SARS-CoV-2. Additionally, we investigated the association of physical activity levels with symptoms of the disease, length of hospital stay, and mechanical ventilation. DESIGN: Observational, cross-sectional. METHODS: Between June 2020 and August 2020, we invited Brazilian survivors and fully recovered patients infected with SARS-CoV-2 to respond to an online questionnaire. We shared the electronic link to the questionnaire on the internet. We collected data about clinical outcomes (symptoms, medications, hospitalization, and length of hospital stay) and cofactors, such as age, sex, ethnicity, preexisting diseases, socioeconomic and educational, and physical activity levels using the International Physical Activity Questionnaire (IPAQ short version). RESULTS: Out of 938 patients, 91 (9.7%) were hospitalized due to COVID-19. In a univariate analysis, sex, age, and BMI were all associated with hospitalizations due to COVID-19. Men had a higher prevalence of hospitalization (66.6%, p = 0.013). Patients older than 65 years, obese, and with preexisting disease had a higher prevalence of COVID-19-related hospitalizations. In a multivariate regression model, performance of at least 150 min/wk (moderate) and/or 75 min/wk (vigorous) physical activity was associated with a lower prevalence of hospitalizations after adjustment for age, sex, BMI, and preexisting diseases (PR = 0.657; p = 0.046). CONCLUSIONS: Sufficient physical activity levels were associated with a lower prevalence of COVID-19-related hospitalizations. Performing at least 150 min a week of moderate-intensity, or 75 min a week of vigorous-intensity physical activity was associated with 34.3% reduction in prevalence.

Exercise training modalities for heart transplant recipients: a systematic review and network meta-analysis protocol.

INTRODUCTION: Heart transplantation is the gold standard treatment for selected patients with end-stage heart failure. Although this procedure can improve quality and prolong life expectancy, several of these patients persist with decreased exercise tolerance. Evidence suggests that exercise training can bring multifactorial benefits to heart transplant (HTx) recipients. However, it is unclear that exercise modality should be preferred. Therefore, the aim of this systematic review and network meta-analysis is to compare the efficacy and safety of different training modalities in HTx recipients. METHODS AND ANALYSIS: We will perform a comprehensive literature search in PubMed/MEDLINE, Embase, The Cochrane Library, CINAHL, Scopus, SportDISCUS, Web of Science Core Collection and PEDro from inception until November 2020. Two registries (ClinicalTrials.gov and REBEC) will also be searched for potential results in unpublished studies. There will be no restriction on language, date of publication, publication status or sample size. We will include randomised controlled trials enrolling adult HTx recipients with the presence of at least one exercise training group, which might be compared with another training modality and/or a non-exercise control group for a minimum of 4 weeks of intervention. The primary outcomes will be peak oxygen consumption and occurrence of adverse events. As secondary outcomes, the interaction between pulmonary ventilation, pulmonary perfusion and cardiac output, oxygen uptake efficiency slope, heart rate response, oxygen pulse, peak blood pressure and peak subjective perception of effort. In addition, we will evaluate the 6 min walking distance, health-related quality of life, endothelial function, muscle strength, body fat percentage and lean mass. Risk of bias will be assessed using the Cochrane RoB V.2.0 tool, and we plan to use the Confidence in Network Meta-Analysis tool to assess confidence in the results. All materials (raw data, processed data, statistical code and outputs) will be shared in a public repository. ETHICS AND DISSEMINATION: Given the nature of this study, no ethical approval will be required. We believe that the findings of this study may show which is the most efficacious and safe physical training modality for HTx recipients. The completed systematic review and network meta-analysis will be submitted to a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42020191192.

Effects of Different Rehabilitation Protocols in Inpatient Cardiac Rehabilitation After Coronary Artery Bypass Graft Surgery: A RANDOMIZED CLINICAL TRIAL.

PURPOSE: Patients undergoing coronary artery bypass graft (CABG) surgery typically experience loss of cardiopulmonary capacity in the post-operative period. The purpose of this study was to evaluate the effects of different rehabilitation protocols used in inpatient cardiac rehabilitation on functional capacity and pulmonary function in patient status post-CABG surgery. METHODS: This was a single-blind randomized controlled trial. The primary endpoint of functional capacity and secondary endpoints of lung capacity and respiratory muscle function were assessed in patients scheduled to undergo CABG. After surgery, 40 patients were randomly assigned across 1 of 4 inpatient cardiac rehabilitation groups: G1, inspiratory muscle training, active upper limb and lower limb exercise training, and early ambulation; G2, same protocol as G1 without inspiratory muscle training; G3, inspiratory muscle training alone; and G4, control. All groups received chest physical therapy and expiratory positive airway pressure. Patients were reassessed on post-operative day 6 and post-discharge day 30 (including cardiopulmonary exercise testing). RESULTS: The 6-min walk distance on post-operative day 6 was significantly higher in groups that included exercise training (G1 and G2), remaining higher at 30 d post-discharge (P < .001 between groups). Peak oxygen uptake on day 30 was also higher in G1 and G2 (P = .005). All groups achieved similar recovery of lung function. CONCLUSION: Protocols G1 and G2, which included a systematic plan for early ambulation and upper and lower limb exercise, attenuated fitness losses while in the hospital and significantly enhanced recovery 1 mo after CABG.

Preoperative maximal expiratory pressure is associated with duration of invasive mechanical ventilation after cardiac surgery: An observational study.

OBJECTIVE: To evaluate the association of maximal expiratory pressure (MEP), maximal inspiratory pressure (MIP), and peak expiratory flow (PEF) with total duration of invasive mechanical ventilation (IMV) in subjects undergoing cardiac surgery. BACKGROUND: Prolonged IMV is associated with respiratory infections, prolonged hospitalization, and increased mortality. Pulmonary function tests can help predict postoperative outcomes after cardiac surgery. METHODS: We recruited subjects admitted for cardiac surgery. All MIP, MEP, and PEF measurements were performed before surgery. Multivariable analysis was performed using a multiple linear regression model to control for possible confounders and test for association of MIP, MEP, and PEF with IMV duration. RESULTS: Overall, 125 subjects were included in the study. Higher MEP was associated with reduced duration of IMV after adjustment for confounders (P = 0.015), but no such association was observed between MIP or PEF and IMV. CONCLUSIONS: In subjects undergoing elective cardiac surgery, preoperative MEP is associated with IMV duration.

Tai Chi Chuan improves functional capacity after myocardial infarction: A randomized clinical trial.

BACKGROUND: Patients with a recent myocardial infarction (MI) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption (Vo2 peak). The impact of a Tai Chi Chuan (TCC) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. Our goal is to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent MI. METHODS: A single-blind randomized clinical trial was conducted. The researchers who performed the tests were blinded to group allocation. Between the 14th and 21st days after hospital discharge, all patients performed a cardiopulmonary exercise testing and a laboratory blood workup. Mean age was similar (56±9 years in the TCC group and 60±9 years in the control group). Patients allocated to the intervention group performed 3 weekly sessions of TCC Beijin style for 12 weeks (n=31). The control group participated in 3 weekly sessions of full-body stretching exercises (n=30). RESULTS: After the 12-week study period, participants in the TCC group experienced a significant 14% increase in Vo2 peak from baseline (21.6 ± 5.2 to 24.6 ± 5.2 mL/kg per minute), whereas control participants had a nonsignificant 5% decline in Vo2 peak (20.4 ± 5.1 to 19.4 ± 4.4 mL/kg per minute). There was a significant difference between the 2 groups (P<.0001). CONCLUSIONS: Tai Chi Chuan practice was associated with an increase in Vo2 peak in patients with a recent MI and may constitute an effective form of cardiac rehabilitation in this patient population.