Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial

BackgroundChagas disease (CD) is a neglected endemic disease with worldwide impact due to migration. Approximately 50–70% of individuals in the chronic phase of CD present the indeterminate form, characterized by parasitological and/or serological evidence of Trypanosoma cruzi infection, but without clinical signs and symptoms. Subclinical abnormalities have been reported in indeterminate form of CD, including pro-inflammatory states and alterations in cardiac function, biomarkers and autonomic modulation. Moreover, individuals with CD are usually impacted on their personal and professional life, making social insertion difficult and impacting their mental health and quality of life (QoL). Physical exercise has been acknowledged as an important strategy to prevent and control numerous chronic-degenerative diseases, but unexplored in individuals with the indeterminate form of CD. The PEDI-CHAGAS study (which stands for “Home-Based Exercise Program in the Indeterminate Form of Chagas Disease” in Portuguese) aims to evaluate the effects of a home-based exercise program on physical and mental health outcomes in individuals with indeterminate form of CD.Methods and designThe PEDI-CHAGAS is a two-arm (exercise and control) phase 3 superiority randomized clinical trial including patients with indeterminate form of CD. The exclusion criteria are <18 years old, evidence of non-Chagasic cardiomyopathy, musculoskeletal or cognitive limitations that preclude the realization of exercise protocol, clinical contraindication for regular exercise, and regular physical exercise (≥1 × per week). Participants will be assessed at baseline, and after three and 6 months of follow-up. The primary outcome will be QoL. Secondary outcomes will include blood pressure, physical fitness components, nutritional status, fatigability, autonomic modulation, cardiac morphology and function, low back pain, depression and anxiety, stress, sleep quality, medication use and adherence, and biochemical, inflammatory and cardiac biomarkers. Participants in the intervention group will undergo a home-based exercise program whilst those in the control group will receive only general information regarding the benefits of physical activity. Both groups will receive the same general nutritional counseling consisting of general orientations about healthy diets.ConclusionThe findings from the present study may support public health intervention strategies to improve physical and mental health parameters to be implemented more effectively in this population.Clinical trial registration[https://ensaiosclinicos.gov.br/rg/RBR-10yxgcr9/], identifier [U1111-1263-0153]

Sensitivity and specificity of a rapid diagnostic test for chronic Chagas disease at a referral center in Brazil - can it be included as a standard serological diagnostic test in the clinical practice of a referral center?

Introduction: Chagas disease (CD) is a neglected tropical disease. In the chronic phase of CD, the diagnosis is essentially serologic. Conventional reactions are currently in use. More recently, the use of rapid diagnostic testing (RDT) is indicated when conventional techniques are not available. Objective: To evaluate the sensitivity and specificity of RDTs for chronic CD diagnosis. Methodology: Individuals under suspicion of CD were evaluated using ELISA, Chemiluminescence (ChLIA) and RDT tests. Results: The RDT showed 95.1% sensitivity and 96.7% specificity, respectively. Conclusion: The findings of the present study showed that RDT used in the diagnosis of CD at a referral center in Brazil were not able to detect all CD cases when compared to Elisa and ChLIA

Transcutaneous electrical stimulation of PC5 and PC6 acupoints modulates autonomic balance in heart transplant patients: a pilot study

Submitted by Janaína Nascimento ([email protected]) on 2019-07-04T00:09:56Z No. of bitstreams: 1 ve_Moreira_Beatriz_etal_INI_2019.pdf: 370906 bytes, checksum: 143831fe1640eddf10b48d34f5729f3a (MD5)Approved for entry into archive by Janaína Nascimento ([email protected]) on 2019-07-04T01:32:18Z (GMT) No. of bitstreams: 1 ve_Moreira_Beatriz_etal_INI_2019.pdf: 370906 bytes, checksum: 143831fe1640eddf10b48d34f5729f3a (MD5)Made available in DSpace on 2019-07-04T01:32:18Z (GMT). No. of bitstreams: 1 ve_Moreira_Beatriz_etal_INI_2019.pdf: 370906 bytes, checksum: 143831fe1640eddf10b48d34f5729f3a (MD5) Previous issue date: 2019National Institute of Cardiology. Physiotherapy Service. Rio de Janeiro, RJ, Brazil.Federal University of the State of Rio de Janeiro. Biomedical Institute. Department of Physiological Sciences. Laboratory of Cardiovascular Biophysics. Rio de Janeiro, RJ, Brazil.Federal University of the State of Rio de Janeiro. Biomedical Institute. Department of Physiological Sciences. Laboratory of Cardiovascular Biophysics. Rio de Janeiro, RJ, Brazil.Federal University of the State of Rio de Janeiro. Biomedical Institute. Department of Physiological Sciences. Laboratory of Cardiovascular Biophysics. Rio de Janeiro, RJ, Brazil.National Institute of Cardiology. Education and Research Department. Rio de Janeiro, RJ, Brazil / Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.National Institute of Cardiology. Education and Research Department. Rio de Janeiro, RJ, Brazil.National Institute of Cardiology. Physiotherapy Service. Rio de Janeiro, RJ, Brazil / Federal University of the State of Rio de Janeiro. Biomedical Institute. Department of Physiological Sciences. Laboratory of Cardiovascular Biophysics. Rio de Janeiro, RJ, Brazil.The increased resting heart rate (HR) in heart transplant patients is associated with enhanced metabolic demand, the potential for fatigue, and lower quality of life. In the present study, we hypothesized that transcutaneous electrical acupoint stimulation (TEAS) could modulate autonomic balance and reduce resting HR in these patients. A single-arm clinical trial was conducted with patients aged > 18 years, at ambulatorial accompaniment after heart transplantation, who were submitted to a single TEAS (40 minutes at pericardium channel acupoints PC5 and PC6). The arterial blood pressure and RR interval were recorded from 20 minutes before to 20 minutes after TEAS. The RR intervals were used to calculate HR variability (HRV) and the sympathovagal index. Linear mixed models were used for comparing variables before, during, and after TEAS. The significance level was set as P < 0.05. TEAS acutely improved HRV in transplant patients and enhanced the sympathovagal index during its application. Significant increases in systolic and diastolic blood pressure and mean arterial pressure were observed at recovery, such as a slight, but significant, decrease in HR. In conclusion, TEAS at PC5 and PC6 acutely modulates HRV and hemodynamics in transplant patients

Table_1_The association of exercise test variables with long-term mortality in patients with chronic Chagas disease.pdf

BackgroundThe identification of variables obtained in the exercise test (ET) associated with increased risk of death is clinically relevant and would provide additional information for the management of Chagas disease (CD). The objective of the present study was to evaluate the association of ET variables with mortality in patients with chronic CD.MethodsThis retrospective longitudinal observational study included 232 patients (median age 46.0 years; 50% women) with CD that were followed at the Evandro Chagas National Institute of Infectious Diseases (Rio de Janeiro, Brazil) and performed an ET between 1989 and 2000. The outcome of interest was all-cause mortality.ResultsThere were 103 deaths (44.4%) during a median follow-up of 21.5 years (IQR 25–75% 8.0–27.8), resulting in 24.5 per 1,000 patients/year incidence rate. The ET variables associated with mortality after adjustments for potential confounders were increased maximal (HR 1.02; 95% CI 1.00–1.03 per mmHg) and change (HR 1.03; 95% CI 1.01–1.06 per mmHg) of diastolic blood pressure (DBP) during ET, ventricular tachycardia at rest (HR 3.95; 95% CI 1.14–13.74), during exercise (HR 2.73; 95% CI 1.44–5.20), and recovery (HR 2.60; 95% CI 1.14–5.91), and premature ventricular complexes during recovery (HR 2.06; 1.33–3.21).ConclusionOur findings suggest that ET provides important prognostic value for mortality risk assessment in patients with CD, with hemodynamic (increased DBP during exercise) and electrocardiographic (presence of ventricular arrhythmias) variables independently associated with an increased mortality risk in patients with CD. The identification of individuals at higher mortality risk can facilitate the development of intervention strategies (e.g., close follow-up) that may potentially have an impact on the longevity of patients with CD.</p

Biomarkers and Echocardiographic Predictors of Cardiovascular Outcome in Patients With Chronic Chagas Disease

Background Chagas disease (CD) presents an ominous prognosis. The predictive value of biomarkers and new echocardiogram parameters in adjusted models have not been well studied. Methods and Results There were 361 patients with chronic CD (57.6% men, 61±11 years of age, clinical forms: indeterminate 27.1%, cardiac 56.6%, digestive 3.6%, cardiodigestive 12.7%) included in this single‐center, observational, prospective longitudinal study. Echocardiographic evaluation included strain analyses of left atrial, left ventricular (LV), and right ventricular and 3‐dimensional analyses of left atrial and LV volumes. Biomarkers included cardiac troponin I, brain natriuretic peptide, transforming growth factor β1, tumor necrosis factor, matrix metalloproteinases, and Trypanosoma cruzi polymerase chain reaction. The studied end point was a composite of CD‐related mortality, heart transplant, hospital admission due to worsening heart failure, or new cardiac device insertion. Event‐free survival was analyzed by multivariable regression analyses adjusted for competing risks. P values <0.05 were considered significant. The composite event occurred in 79 patients after 4.9±2.0 years follow‐up. LV end‐diastolic volume (hazard ratio [HR], 1.01 [95% CI, 1.00–1.02]; P=0.02), peak negative global atrial strain (HR, 1.08 [95% CI, 1.00–1.17]; P=0.04), LV global circumferential strain (HR, 1.12 [95% CI, 1.04–1.21]; P=0.003), LV torsion (HR, 0.55 [95% CI, 0.35–0.81]; P=0.003), brain natriuretic peptide (HR, 2.03 [95% CI, 1.23–3.34]; P=0.005), and positive T cruzi polymerase chain reaction (HR, 1.80 [95% CI, 1.12–2.91]; P=0.01) were end point predictors independent from age, sex, 2‐dimensional echocardiographic indexes, hypertension, previous cardiac device, and CD cardiac form. Conclusions Two‐dimensional strain‐ and 3‐dimensional‐derived parameters, brain natriuretic peptide, and positive T cruzi polymerase chain reaction can be useful for prediction of CD cardiovascular events

Data_Sheet_4_Home-based exercise program in the indeterminate form of Chagas disease (PEDI-CHAGAS study): A study protocol for a randomized clinical trial.PDF

BackgroundChagas disease (CD) is a neglected endemic disease with worldwide impact due to migration. Approximately 50–70% of individuals in the chronic phase of CD present the indeterminate form, characterized by parasitological and/or serological evidence of Trypanosoma cruzi infection, but without clinical signs and symptoms. Subclinical abnormalities have been reported in indeterminate form of CD, including pro-inflammatory states and alterations in cardiac function, biomarkers and autonomic modulation. Moreover, individuals with CD are usually impacted on their personal and professional life, making social insertion difficult and impacting their mental health and quality of life (QoL). Physical exercise has been acknowledged as an important strategy to prevent and control numerous chronic-degenerative diseases, but unexplored in individuals with the indeterminate form of CD. The PEDI-CHAGAS study (which stands for “Home-Based Exercise Program in the Indeterminate Form of Chagas Disease” in Portuguese) aims to evaluate the effects of a home-based exercise program on physical and mental health outcomes in individuals with indeterminate form of CD.Methods and designThe PEDI-CHAGAS is a two-arm (exercise and control) phase 3 superiority randomized clinical trial including patients with indeterminate form of CD. The exclusion criteria are ConclusionThe findings from the present study may support public health intervention strategies to improve physical and mental health parameters to be implemented more effectively in this population.Clinical trial registration[https://ensaiosclinicos.gov.br/rg/RBR-10yxgcr9/], identifier [U1111-1263-0153].</p

Disruption to diabetes and hypertension care during the COVID-19 pandemic in Latin America and the Caribbean and mitigation approaches: a scoping review

Background The COVID-19 pandemic disrupted care for non-communicable diseases globally. This study synthesizes evidence on disruptions to primary care, focusing on hypertension and diabetes care and mitigation approaches taken during the pandemic in Latin America and the Caribbean (LAC). Methods We conducted a scoping review, searching nine electronic databases for studies from January 2020 to December 2022 on COVID-19-related primary care disruptions and interventions, including studies on hospital-based interventions given their relevance to the pandemic response in LAC. We adapted the Primary Health Care Performance Initiative framework to develop our search strategy and synthesize data. For studies reporting interventions, we included studies conducted outside of LAC. Findings Of 33,510 references screened, 388 studies were included (259 reported disruptions in LAC, 61 interventions in LAC, 63 interventions outside LAC, and five interventions from countries within and outside LAC), with three-quarters presenting data from Brazil, Argentina, Mexico, and Peru; few studies focused on rural areas. Additionally, the few studies that adequately quantified care disruptions reported a reduction in hypertension and diabetes control during the pandemic (e.g., hypertension control rate decreased from 68% to 55% in Mexico). Frequently reported causes of disruption included burnout and mental health challenges among healthcare workers (with disproportionate effects by type of worker), reduced medication supplies, and reduced frequency of clinic visits by patients (e.g., due to financial constraints). The most reported interventions included remote care strategies (e.g., smartphone applications, virtual meeting platforms) and mental health programs for healthcare workers. Remote care strategies were deemed feasible for care delivery, triaging, and clinical support for non-physicians. Patients were generally satisfied with telemedicine, whereas providers had mixed perceptions. Robust evidence on the effectiveness of remote care strategies for diabetes and hypertension care was unavailable in LAC. Interpretation Hypertension and diabetes control appeared to worsen in LAC during the pandemic. Major reported causes of care disruptions were workforce issues, reduced medication supply, and changes in patient perceptions of seeking and receiving primary healthcare. Remote care strategies were feasible for various purposes and were well received by patients. However, the lack of data on intervention effectiveness underscores the importance of strengthening research capacity to generate robust evidence during future pandemics. Developing resilient healthcare systems able to provide care for hypertension and diabetes during future pandemics will depend on investment in the healthcare workforce, medical supply chain, health data and research infrastructure, and technology readiness. Funding This work was supported by funding from the World Bank to Johns Hopkins Bloomberg School of Public Health and RCSI University of Medicine and Health Sciences. Additional support to RCSI was provided by Science Foundation Ireland, Converge Programme, grant number 22/RP/10091.</p