intention-to-treat and per-protocol analysis. Results Four hundred and forty-seven subjects were randomized to INT ( n = 224) or to usual care ( n = 223). After 36 months ESC-SCORE development favouring INT was observed (INT: 8.70% to 10.03% vs. usual care: 8.49% to 12.09%; p = 0.005; net difference: 18.50%). Moreover, a significant reduction in the composite cardiovascular events was observed: (INT: n = 11 vs. usual care: n = 27). Hazard ratio of intervention versus control was 0.51 (95% confidence interval 0.25-1.03; p = 0.062) in the intention-to-treat analysis and 0.41 (95% confidence interval 0.18-0.90; p = 0.026) in the per-protocol analysis, respectively. No intervention-related adverse events or side-effects were observed. Conclusions Our results demonstrate the efficiency of identifying cardiovascular high-risk subjects by the ESC-SCORE in order to enrol them to a risk adjusted primary prevention programme. This strategy resulted in a significant improvement of ESC-SCORE, as well as a reduction in predefined cardiovascular endpoints in the INT within 36 months. (ISRCTN 23536103.).
Background: Scientific guidelines have been developed to update and harmonize exercise based cardiac rehabilitation (ebCR) in German speaking countries. Key recommendations for ebCR indications have recently been published in part 1 of this journal. The present part 2 updates the evidence with respect to contents and delivery of ebCR in clinical practice, focusing on exercise training (ET), psychological interventions (PI), patient education (PE). In addition, special patients’ groups and new developments, such as telemedical (Tele) or home-based ebCR, are discussed as well. Methods: Generation of evidence and search of literature have been described in part 1. Results: Well documented evidence confirms the prognostic significance of ET in patients with coronary artery disease. Positive clinical effects of ET are described in patients with congestive heart failure, heart valve surgery or intervention, adults with congenital heart disease, and peripheral arterial disease. Specific recommendations for risk stratification and adequate exercise prescription for continuous-, interval-, and strength training are given in detail. PI when added to ebCR did not show significant positive effects in general. There was a positive trend towards reduction in depressive symptoms for “distress management” and “lifestyle changes”. PE is able to increase patients’ knowledge and motivation, as well as behavior changes, regarding physical activity, dietary habits, and smoking cessation. The evidence for distinct ebCR programs in special patients’ groups is less clear. Studies on Tele-CR predominantly included low-risk patients. Hence, it is questionable, whether clinical results derived from studies in conventional ebCR may be transferred to Tele-CR. Conclusions: ET is the cornerstone of ebCR. Additional PI should be included, adjusted to the needs of the individual patient. PE is able to promote patients self-management, empowerment, and motivation. Diversity-sensitive structures should be established to interact with the needs of special patient groups and gender issues. Tele-CR should be further investigated as a valuable tool to implement ebCR more widely and effectively.
The improvement in mean maximal performance of 100.5+/-31.4 to 123.1+/-36.2 W (p<0.01) achieved during CR was further improved to 128.7+/-40.9 W (p < 0,01) after 24 months. Of the patients, 61.2% reported regular physical activity during the 24 months of the study. The lipid management achieved by CR was maintained over 24 month. At I 65%, at II 84.4% and at V 82.4% of the patients with coronary artery disease (CAD) were undergoing lipid lowering therapy. BMI increased from 26.8+/-3.0 to 27.6+/-3.6 kg/m2 (p < 0.01) during follow-up. Of the patients, 23.2% were active smokers at V. Cardiovascular diagnosis remained unaltered in 74.3% of patients. The obtained results are interesting with respect to the social status of the patients since 68% were general laborers. The results confirm the long-term effectiveness of an intensive 3-week out-patient CR programme. Most of the benefits achieved by CR appear to be sustainable in this population for at least 2 years.
Fewer patients in the intervention group were admitted and readmitted to hospital, and lower inpatient treatment costs were identified. The physician contact rate was higher than in the control group.
From October 1994 to July 1996, 128 patients (30 women, 98 men) participated in an outpatient cardiac rehabilitation program (phase II). Our objectives were to demonstrate risk-factor modification and increased workload capacity resulting directly from the rehabilitation in terms of primary results and long-term effects 6 and 12 months (n = 118, Figure 1) respectively 1.5 and 2 years (n = 87) after termination of the program (Tables 9 to 12). We observed how many of the patients were able to be occupationally reintegrated after completion of phase-II rehabilitation. Workload capacity significantly increased from 1.2 W/kg upon entry to 1.5 W/kg (p < or = 0.05) upon completion of 4 weeks cardiac rehabilitation. Workload capacity remained consistently high at 6 months and 1 year (1.5 W/kg) and at 1.5 and 2 years (1.7 W/kg). Total cholesterol decreased significantly from 247 to 201 mg/dl (p < or = 0.05) during the 4-week program. Significant cholesterol (p < or = 0.01) reductions persisted at 6 months (216 mg/dl) and 1 year (215 mg/dl). After 1.5 and 2 years, the total cholesterol was less than 14% and 17% below the mean of cholesterol at the beginning of the program. Similarly, LDL cholesterol was 185 mg/dl before entering the program, 146 mg/dl after 4 weeks, 151 mg/dl after 6 months and 149 mg/dl after 1 year. Triglyceride levels showed a significant reduction (p < or = 0.01) with levels 189 mg/dl before entering the program, 148 mg/dl after 4 weeks, 151 mg/dl after 6 months and 154 mg/dl after 1 year. LDL cholesterol and triglyceride levels did not significantly increase after 1.5 and 2 years. The HDL cholesterol increased slightly as a long-term effect (from 51 mg/dl before entering the program to 55, 56 and 54 mg/dl after 1, 1.5 and 2 years, respectively). Seventy-three percent of the patients questioned (n = 73) found the program very good, 27% said it was good and no patient was dissatisfied. Fifty-one (81%) of the 63 patients who were actively employed before becoming ill and later entering our program were immediately able to be reintegrated into their previous occupation. In several cases reintegration took 7 weeks. Seven (11%) patients applied for pension, 5 (8%) patients remained unemployed on sick-leave.
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