ABSTRACT
Background: The Diabetes College Brazil Study (NCT03914924) is a pioneer randomized clinical trial designed to promote behavioral changes in adults living with prediabetes and diabetes. Method(s): A single-center randomized pilot study involving a 12-week exercise intervention aiming the participants accumulate at least 150 min of aerobic exercise and two sessions of resistance exercise per week with a 6-month follow-up after the intervention. The follow-up objective was to support the participants in maintaining the health benefits arising from the intervention through monthly structured phone calls. Physical activity (PA) level (seven days using a pedometer), exercise self-efficacy (Bandura's Exercise Self-Efficacy Scale), and quality of life (Medical Outcomes Study 36-Item Short-Form Health Survey) were assessed at pre, post-intervention (PI), and post-follow-up (PF). Variables measured in the PI and PF were compared by unpaired t-test. The aerobic exercise time in minutes/week was collected during monthly phone calls and compared by ANOVA. The weekly frequency of resistance exercise sessions was also collected and analyzed by absolute frequencies. The association between the interest variables was analyzed using the Pearson correlation test. Result(s): Of 21 participants who were assessed at PF, 12 answered all phone calls along with follow-up (75% male, 57.4 +/- 10.7 years, 8.3% prediabetes, 41.6% Type 1 diabetes, and 50% Type 2 diabetes) and were included in this study. There was no significant difference between the values obtained in the PI and PF for PA level (41947+/-28868 vs. 49915+/-33054 total steps/week, 5992+/-4124 vs. 7131+/-4722 average steps/day;P=0.09), exercise self-efficacy (65.6+/-13.1 vs. 71.8+/-22.3;P=0.31), physical health (82.7+/-22,84.1 vs. 81.4+/-20.5;P=0.64) and mental health (65.9+/-40.7 vs. 70,5+/-38,4;P=0.70) components of quality of life, revealing maintenance of the exercise intervention benefits after six months. Most participants aerobically exercised above 150 min/week in moderate-intensity during the follow-up, with no change in average exercise time over the six months (225.0+/-154.8, 197.0+/-133.9, 235.0+/-143.9, 142.0+/-102.6, 174.0+/-177.5 minutes/week;P=0.12). The proportion of participants who maintained resistance exercise were 41%, 58%, 66%, 50%, and 50%, and the average weekly frequency was more than three times a week during the follow-up. The average minutes of aerobic exercise/week during the follow-up was moderately correlated with total steps/week (r=0.59, P=0.06) and with mental (r=0.49, P=0.12) and physical (r=0.49, P=0.12) health components of quality of life, and strongly correlated with exercise self-efficacy (r=0.63, P=0.04). Conclusion(s): Participants maintained the health benefits of the intervention at the six-month follow-up, despite the social restrictions due to the COVID-19 pandemic.
ABSTRACT
Background: Lifestyle changes are crucial to preventing diabetes and its cardiovascular complications, including maintaining a physically active lifestyle. Morever, patient education is essential to promote diabetes self-management and health condition control. However, programs that combine physical exercise and lifestyle education are still poorly implemented in low- and middle-income countries, such as Brazil. The Diabetes College Brazil Study is a pioneer randomized clinical trial (RCT) designed to promote behavioral changes in adults with diabetes and prediabetes. PURPOSE: To test the feasibility, acceptability, and preliminary effectiveness of Diabetes College Brazil Study interventions (Exercise (Ex) vs. Exercise and Lifestyle Education (ExLE)) as part of the preparation for the development of the RCT. Methods: This pilot randomized trial (NCT03914924) had two parallel arms: ExLE program (12 weeks of exercise and educational interventions) and Ex program (12 weeks of exercise intervention only) (Figure 1). Feasibility (eligibility, recruitment, retention, completeness of RCT variables measures and participation rates), acceptability (satisfaction with interventions), and preliminary effectiveness of interventions (comparison of RCT variables measured in pre-and post-assessments) were evaluated. The preliminary effectiveness of the interventions was analyzed from the values of the difference between post-and pre-intervention measures (Δ post-pre) using both per-protocol (PP) and intention to treat (ITT) analysis for the comparison between groups (Ex vs. ExLE). The value 0 was imputed to replace the missing data in the analysis that followed the ITT principle. The results were reported as estimates of effect (95% confidence interval (CI) of the difference) for variables with normal distribution. RESULTS: Thirty-seven individuals participated in the study (ExLE: n = 18, 56.9±9.5 years old, 55.6% female, 5.6% prediabetes;Ex: n = 19, 59.5±7.3 years old, 52.6% female, 21.1% prediabetes). Eligibility, recruitment and retention rates were 16%, 100% and 82% respectively. The completeness of RCT variables measures was higher in the pre-intervention assessment. Missing data in the post-intervention assessment were mainly related to modifications in research procedures due to the COVID-19 pandemic. Participation rates in supervised exercise sessions and education classes were 76% and 71%, respectively (total sample). Interventions were highly acceptable to participants. There was a trend towards better results in the ExLE than Ex for most variables, mainly for physical activity level and quality of life (Table 1). Conclusion: The interventions are feasible and acceptable to participants. The results of this trial indicate the potential clinical benefit of lifestyle educational intervention associated with exercise intervention for people with diabetes and prediabetes. (Figure Presented).
ABSTRACT
Background: Asthma is a chronic respiratory disease, and respiratory viruses are well-known triggers for asthma exacerbations. The novel coronavirus named SARS-CoV-2, which causes COVID-19, can present with pulmonary symptoms. Several studies suggest that IL-13, an allergic asthma mediator, should prevent asthma exacerbations by SARS-CoV-2. The objective of this study was to evaluate the clinical behavior of patients with asthma during the COVID-19 pandemic. Asthma is a chronic respiratory disease, and respiratory viruses are well-known triggers for asthma exacerbations.The novel coronavirus named SARS-CoV-2, which causes COVID-19, can present with pulmonary symptoms.Several studies suggest that IL-13, an allergic asthma mediator, should prevent asthma exacerbations by SARS-CoV-2. The objective of this study was to evaluate the clinical behavior of patients with asthma during the COVID-19 pandemic. Method: This was a retrospective study of electronic medical records of adult asthmatic patients, being followed up in a tertiary service and who received telephone calls for rescheduling the face-to-face consultations, during the COVID-19 pandemic period.Demographic data, asthma symptoms, frequency of atopy, presence of comorbidities and symptoms related to coronavirus infection were analyzed. Patients were classified according to their history of asthma attacks. Results: Two hundred and seven patients were included, and of them, 165 patients (79.7%) were female, with a mean age of 53.3 years and asthma duration of 35 years. Atopy was confirmed in 156 patients (81.7%). The main comorbidities were obesity (32.9%), high blood pressure (47.3%), diabetes mellitus (17.4%) and emotional stress (68.1%). Of the total, 87 patients (42%) had acute symptoms, of which 20 (9.7%) sought emergency care and 15 of 20 patients (75%) were investigated for Covid-19, all of which were negative. Of the total, only 7 patients (3.4%) exacerbated and required systemic corticosteroids. During this study, the more frequent complaints among asthmatic patients with acute respiratory symptoms were dyspnea, cough, asthenia and headache when compared to those without a crisis (p < 0.05). Conclusion: This study found that asthmatic patients had a low prevalence of asthma exacerbation during the coronavirus pandemic period. Patients with acute symptoms may have been underdiagnosed for COVID-19, due to the low demand for emergency care. Previous atopy may act as a protective factor for COVID-19 in asthmatic patients.