The impact of knowledge on the functioning of patients with coronary artery disease

Introduction: The functioning of patients with chronic disease is inseparably connected with the understanding of the essence of the disease, acceptance of the disease, and taking measures leading to achieving the best possible treatment results. Aim of the study: The aim of the study was to evaluate the influence of patients’ knowledge on their functioning in coronary artery disease, which was assessed with the aid of the tool ‘The Functioning in Chronic Illness Scale’ (FCIS). Materials and methods: A single-centre prospective, observational study was conducted on 202 patients hospitalized due to coronary artery disease. In the study, patients’ knowledge was assessed (subjective method: self-assessment report; objective method: an APK questionnaire which assesses familiarity with symptoms, knowledge about the disease and disease prevention), as well as the functioning in a chronic illness (FCIS scale which checks the impact of a disease on the patient, the influence of the patient on the disease and the impact of a disease on attitudes). Results: The distribution of FCIS results varied depending on self-assessment regarding the level of know- ledge (p = 0.04). High result was achieved by 27% respondents who declared a sufficient level of knowledge, and 38% of those respondents who declared insufficient knowledge. The analysis of the impact of knowledge on various areas of functioning in coronary artery disease has shown that patients with a higher level of knowledge about the disease and its prevention achieved better results in the subscale which evaluates patients’ opinion on the possibility of influencing the course of disease (p = 0.039). This observation was confirmed by a weak positive correlation (R = 0.193; p = 0.006). Discussion and conclusions: Reliable information about a disease, available therapeutic plans and prevention procedures help patients understand their health condition and let them take decisions with full awareness. The correlation noticed in the study between patients’ knowledge resources regarding the disease and its prevention and their convictions about the possibilities of having influence on the course of the disease is a strong argument supporting the claim that conducting coordinated educational interventions for patients with coronary artery disease is a legitimate task

Post-COVID-19 rehabilitation (PCR-SIRIO 8) study. A rationale and protocol of the study

A substantial proportion of the COVID-19 survivors require the physical and mental support due to the post COVID-19 syndrome. In response to this demand a comprehensive rehabilitation program tailored to the individual needs has been developed. The program is linked with a Post-COVID-19 Rehabilitation (PCR-SIRIO 8) study that aims to objectively evaluate the outcomes of the post-COVID-19 rehabilitation. The study was designed as a prospective, single-center, observational study involving patients suffering from post-COVID-19 syndrome. Patients meeting the inclusion criteria are invited for an initial visit including medical and physiotherapeutic examination. Rehabilitation program includes physical training, therapeutic education, and psychotherapeutic workshops. Individual psychotherapeutic, educational and medical visits are carried out additionally depending on the patient’s needs. Closing visit evaluates individual effects of the rehabilitation program. We believe that our observational study will provide knowledge necessary to optimize post-COVID-19 rehabilitation

Efficacy of double vs. standard empagliflozin dose for METabolic syndromE tReatment (DEMETER — SIRIO 11) study. Rationale and protocol of the study

Complex metabolic disorders associated with obesity and diabetes pose a serious therapeutic challenge. The DEMETER-SIRIO 11 study is a phase III, multicenter, randomized, open-label, investigator-initiated clinical trial with a 6-month follow-up aimed at performing a comparative evaluation of the effect of two empagliflozin doses (10 mg vs. 20 mg) on selected metabolic parameters in patients with metabolic syndrome. The primary hypothesis of the study is that a higher dose of empagliflozin will result in a significant reduction of BMI and HbA1c in patients with obesity and MS receiving empagliflozin 20 mg as compared to 10 mg. Sample size and power calculation were based on a superiority assumption for the primary efficacy endpoint (the difference in decrease of body weight by > 1.5 kg and HbA1c by > 0.4%) for the higher vs. standard dose arm at 6-months of follow-up. Therefore, a sample size of 79 patients per arm is required to provide 80% power to detect a higher decrease in BMI, and 85 patients per arm is required to provide 80% power to detect a higher decrease in HbA1c in the 20 mg versus 10 mg arm with a type I error rate of 0.05. Summing up, enrollment of a total of 200 patients (100 in each arm) is planned to compensate for the potential drop-out rate from the study of up to 15%. Prespecified subanalyses will be performed according to: 1) diabetes mellitus; 2) chronic kidney disease (GFR < 60 mL/min/1.73 m2); 3) gender; and 4) age. A greater comprehensive improvement in biochemical, functional, and anthropometric parameters reflecting favorable metabolic changes is expected at the higher dose of empagliflozin compared to the standard dose

Achieving Cardiovascular Risk Management Goals and Patient Quality of Life

(1) Background: Eliminating or reducing the severity of modifiable risk factors of cardiovascular disease (CVD) and undertaking health-promoting behaviors is the basis for prevention. (2) Methods: This study included 200 subjects without a history of CVD, aged 18 to 80 years, who had been diagnosed with hypertension, hypercholesterolemia, or diabetes 6 to 24 months before study enrolment. (3) Results: The median 10-year CV risk assessed by the SCORE2 and SCORE2-OP algorithms was 3.0 (IQR 1.5–7.0). An increase in mean cardiovascular risk in the range from low and moderate to very high was associated with a decrease in quality of life both in individual subscales and the overall score. The median number of controlled risk factors was 4.0 (IQR 3.0–5.0). As the mean number of controlled risk factors increased, the quality of life improved in both of HeartQoL questionnaire subscales (emotional p = 0.0018; physical p = 0.0004) and the overall score (global p = 0.0001). The median number of reported health-promoting behaviors undertaken within 3 years before study enrolment was 3.0 (IQR 2.0–4.0). The highest quality of life in each of the studied dimensions was found in people who reported undertaking three health-promoting behaviors. (4) Conclusions: Controlling CVD risk factors and undertaking health-promoting behaviors has a positive impact on the quality of life of patients without a history of atherosclerotic CVD

Effects of Multidisciplinary Rehabilitation Program in Patients with Long COVID-19: Post-COVID-19 Rehabilitation (PCR SIRIO 8) Study

Up to 80% of COVID-19 survivors experience prolonged symptoms known as long COVID-19. The aim of this study was to evaluate the effects of a multidisciplinary rehabilitation program in patients with long COVID-19. The rehabilitation program was composed of physical training (aerobic, resistance, and breathing exercises), education, and group psychotherapy. After 6 weeks of rehabilitation in 97 patients with long COVID-19, body composition analysis revealed a significant decrease of abdominal fatty tissue (from 2.75 kg to 2.5 kg; p = 0.0086) with concomitant increase in skeletal muscle mass (from 23.2 kg to 24.2 kg; p = 0.0104). Almost 80% of participants reported dyspnea improvement assessed with the modified Medical Research Council scale. Patients’ physical capacity assessed with the 6 Minute Walking Test increased from 320 to 382.5 m (p p p p < 0.0001). Cardiopulmonary exercise test did not show any change. The multidisciplinary rehabilitation program has improved body composition, dyspnea, fatigue and physical capacity in long COVID-19 patients

Gender-Related Effectiveness of Personalized Post-COVID-19 Rehabilitation

Background: Post-COVID-19 syndrome (PCS) may affect a substantial proportion of patients who have had COVID-19. The rehabilitation program might improve the physical capacity, functioning of the cardiopulmonary system, and mental conditions of these patients. This study aimed to investigate the effectiveness of personalized rehabilitation in patients with PCS according to gender. Methods: Adults who underwent a 6-week personalized PCS rehabilitation program were enrolled in a prospective post-COVID-19 Rehabilitation (PCR-SIRIO 8) study. The initial visit and the final visit included the hand-grip strength test, the bioimpedance analysis of body composition, and the following scales: modified Borg’s scale, Modified Fatigue Impact Scale (MFIS), Functioning in Chronic Illness Scale (FCIS), modified Medical Research Council (mMRC) dyspnea scale, and tests: 30 s chair stand test (30 CST), Six-Minute Walk Test (6MWT), Short Physical Performance Battery test (SPPB)e. Results: A total of 90 patients (54% female) underwent the rehabilitation program. Rehabilitation was associated with an increase in skeletal muscle mass (24.11 kg vs. 24.37 kg, p = 0.001) and phase angle (4.89° vs. 5.01°, p = 0.001) and with a reduction in abdominal fat tissue volume (3.03 L vs. 2.85 L, p = 0.01), waist circumference (0.96 m vs. 0.95 m, p = 0.001), and hydration level (83.54% vs. 82.72%, p = 0.001). A decrease in fat tissue volume and an increase in skeletal muscle mass were observed only in females, while an increase in grip strength was noticed selectively in males. Patients’ fatigue (modified Borg’s scale, MFIS), physical capacity (30 CST, 6MWT), balance (SPPB), dyspnea (mMRC), and functioning (FICS) were significantly improved after the rehabilitation regardless of gender. Conclusions: Personalized rehabilitation improved the body composition, muscle strength, and functioning of patients diagnosed with PCS. The beneficial effect of rehabilitation on body composition, hydration, and phase angle was observed regardless of gender

Determinants of Lipid Parameters in Patients without Diagnosed Cardiovascular Disease—Results of the Polish Arm of the EUROASPIRE V Survey

To assess the determinants of lipid parameters in primary care patients without diagnosed cardiovascular disease (CVD), a cross-sectional study was conducted during 2018–2019 with a total of 200 patients. The following lipid parameters were measured: total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), small, dense LDL (sdLDL-C), and lipoprotein (a) (Lp(a)). Predictors of elevated and adequately controlled lipid parameters were assessed with logistic regression analysis. Older age was related to higher risk of TC ≥ 6.2 mmol/L [OR 1.03 (95% CI 1.0–1.05)], sdLDL-C ≥ 1.0 mmol/L [OR 1.05 (95% CI 1.0–1.1)], and decreased risk of Lp(a) ≥ 50 mg/dL [OR 0.97 (95% CI 0.94–0.99)]. Patients with diabetes mellitus (DM) had increased probability of TG ≥ 2.25 mmol/L [OR 3.77 (95% CI 1.34–10.6)] and Lp(a) ≥ 50 mg/dL [OR 2.97 (1.34–6.10)] as well as adequate control of TG and Lp(a). Higher material status was related to lower risk of TC ≥ 6.2 mmol/L [OR 0.19 (95% CI 0.04–0.82)] and LDL-C ≥ 3.6 mmol/L [OR 0.33 (95% CI 0.12–0.92)]. High BMI was related to increased [OR 1.14 (95% CI 1.02–1.29)], and female gender [OR 0.33 (95% CI 0.12–0.96)] and hypertension [OR 0.29 (95% CI 0.1–0.87)] to decreased risk of TG ≥ 2.25 mmol/L [OR 1.14 (95% CI 1.02–1.29)]. Taking lipid-lowering drugs (LLD) was associated with LDL-C < 2.6 mmol/L [OR 2.1 (95% CI 1.05–4.19)] and Lp(a) < 30 mg/dL [OR 0.48 (95% CI 0.25–0.93)]. Physical activity was related to LDL-C < 2.6 mmol/L [OR 2.02 (95% CI 1.02–3.98)]. Higher abdominal circumference was associated with decreased risk of TG < 1.7 mmol/L [OR 0.96 (95% CI 0.93–0.99)]. Elevated lipid parameters were related to age, gender, material status, BMI, history of DM, and hypertension. Adequate control was associated with age, education, physical activity, LLD, history of DM, and abdominal circumference

Determinants of the level of anti-SARSCoV- 2 IgG ANTibodiEs after vaccination (DANTE-SIRIO 7) study. A rationale and protocol of the study

Introduction: Great expectations to control the pandemic are placed on vaccines against COVID-19. So far, four COVID-19 vaccines have been approved for use in the European Union. This study aimed to assess the anti-SARS-CoV-2 IgG antibody concentration after the vaccination cycle with the BNT162b2 vaccine at several predefined time points. All results will be compared to the COVID-19 history and severity of symptoms during the disease and after the first and second vaccine dose. Material and methods: The study includes healthy, unselected volunteers from the staff of Dr. Antoni Jurasz University Hospital No.1 in Bydgoszcz and students of the Collegium Medicum, Nicolaus Copernicus University. To meet the inclusion criteria all individuals will have to be vaccinated with two doses of the BNT162b2 (BioNTech/Pfizer, US) vaccine. Anti-SARS-CoV-2 IgG antibody concentrations will be measured in fresh serum samples collected from each participant at predefined time points. All measurements will be performed using the Atellica system (Siemens Healthineers, Erlangen, Germany). Results of SARS-CoV-2 IgG are given as U/mL, whereby the cut-off for positivity is defined as ≥ 1.0 U/mL. Discussion: This study was designed to evaluate the impact of COVID-19 on the severity of clinical symptoms and the levels of anti-SARS-CoV-2 IgG antibodies after vaccination. Hopefully, based on its results, further clinical outcome-powered trials will be designed and conducted to elucidate how quantitative antibody levels can be used as a correlate of vaccine-mediated protection