[The PreFord Study. A prospective cohort study to evaluate the risk of a cardiovascular event (overall-collective) as well as a prospective, randomized, controlled, multicentre clinical intervention study (high-risk-collective) on primary prevention of cardiovascular diseases in the Ford Motor Company employees in Germany]
D B Gysan, J Latsch, B Bjarnason-Wehrens, C Albus, G Falkowski, G Herold, E Mey, R Heinzler, G Montiel, C A Schneider, H Stützer, S Türk, M Weisbrod, H G Predel
Ambulantes kardiologisches Rehazentrum, AmKaRe Rolshover-Hof, Köln-Poll, Rolshover-Str. 526, 51105 Köln, Germany. AmKaRe@web.de
The PreFord Study is a multicenter prospective cohort study to evaluate guideline based risk management on primary prevention of cardiovascular diseases. Furthermore a randomised controlled trial (RCT) will be designed to analyse the effect of a special intervention program. 40,000 employees of the Ford Motor Company, Visteon Company and Deutz Company in Germany will be included, monitored for ten years and the following primary endpoints will be investigated: 1. evaluation and comparison of established and newly developed risk-scores, 2. the relative impact of single and combined cardiovascular risk factors on cardiovascular diseases, 3. the influence of a novel occupationally integrated ambulant rehabilitation program in combination with a guideline oriented optimal drug therapy within a high risk group on the primary endpoint: risk reduction by, 4. the influence of this intervention on secondary endpoints: death, myocardial infarction and stroke, combined appearance of angina pectoris and hospitalisation, occurrence of cerebral circulatory disorder and hospitalisation, occurrence of peripheral occlusive arterial disease and hospitalisation and single cardiovascular risk factors and cost-benefit-analysis. Beginning with an cross sectional study there will be a systemic screening of cardiovascular risk profiles, of anthropometric data and different lifestyle-factors. Based on these data participants will be differentiated into three risk-groups according to the risk score of the European Society of Cardiology (risk of a lethal primary acute cardiovascular event: I < or = 1%; II > 1-< 5% and III > or = 5%). In the following longitudinal study different strategies will be applied: Group I: low risk (< 0.5% per year): repetition of the investigation after five and ten years. Group II: middle risk,(0.6% to 1.4% per year), repetition of the investigation every two years, instruction of the patients general practitioner (GP) with respect to a risk factor oriented and evidence based treatment. Group III: high risk,(> 1.5% per year or >15% within the next 10 years) will be randomised into two interventional groups. The first one, the intervention-group "PreFord" will perform an occupational integrated rehabilitation program (2,5-3 hours twice a week, for 15 weeks according to the BAR guidelines) with a following engagement in heart-groups and an annual repetition of the check-ups. The second group, the "classic" intervention-group will be treated evidence based in cooperation with their GP.As a result of this long term interventional study efficient, area wide implementable and economically feasible prevention concepts with special regards to operational healthcare will be developed and evaluated. Core elements will be exercise- and lifestyle-oriented concepts as well as guideline-based pharmacotherapy.
Prevalence of Cardiovascular Risk Factors in Middle-Aged Type 2 Diabetic Automobile Employees Assessed at the Workplace-The Praeford Study.
Christian Schneider, Gerd Herold, Detlev Gysan, Christian Albus, Birna Bjarnason-Wehrens, Hans-Georg Predel
From the Departments of Internal Medicine (Dr Schneider), Clinic III, and Psychosomatics and Psychotherapy (Dr Albus), University of Cologne, Germany; Ford Werke GmbH (Dr Herold), Cologne, Germany; Ambulantes, kardiologisches Rehazentrum (Dr Gysan), AmKaRe, Cologne, Germany; and the Institute for Cardiology and Sports Medicine (Drs Bjarnason-Wehrens and Predel), German Sport University, Cologne, Germany.
OBJECTIVE:: The purpose of this study was to provide contemporary data on the prevalence of cardiovascular risk factors in middle-aged diabetic employees in Germany. METHODS:: Cardiovascular risk factors were assessed at the workplace in employees of the automobile industry who identified themselves as having type 2 diabetes mellitus. The proportion of subjects reaching the target values for hemoglobin A1c (HbA1c), systolic blood pressure, and low-density lipoprotein (LDL) cholesterol was analyzed. RESULTS:: Among 4234 employees, 91 employees with diabetes were identified (mean age, 52 years). Only 7 of 91 (8%) diabetic employees achieved all three recommended target values. Blood pressure targets were achieved by 26%, HbA1c target value by 54%, and LDL target value by 31% of employees. CONCLUSION:: Only a negligible proportion of working people with diabetes achieve the recommended target values. This sobering result questions current management modalities and calls for new treatment and monitoring strategies for working people with diabetes.
Other papers by authors:
C Graf, B Koch, E Kretschmann-Kandel, G Falkowski, H Christ, S Coburger, W Lehmacher, B Bjarnason-Wehrens, P Platen, W Tokarski, H G Predel, S Dordel
1Institute of Cardiology and Sports Medicine, German Sport University, Cologne, Germany.
INTRODUCTION:: The prevalence of childhood obesity is increasing with its negative medical and psychosocial consequences. This paper examines the association between body mass index (BMI), motor abilities and leisure habits of 668 children within the CHILT (Children's Health InterventionaL Trial) project. METHOD:: A total of 668 children (51.0% boys; 49.0% girls) and their parents were questioned on sport and leisure behaviour of the children. The anthropometric data were measured. Motor abilities were determined by a body gross motor development test for children (Köperkoordinationstest für Kinder; KTK) and a 6-min run. RESULTS:: The children were 6.70+/-0.42 y old, 122.72+/-5.36 cm tall and weighed 24.47+/-4.59 kg, the average BMI was 16.17+/-2.27 kg/m(2). KTK showed an average motor quotient (MQ) of 93.49+/-15.01, the 6-min run an average of 835.24+/-110.87 m. Both tests were inversely correlated with BMI (KTK and BMI r=-0.164 (P<0.001); 6-min run and BMI r=-0.201 (P<0.001)); the group of overweight/obese children showed poorer results than the normal/underweight ones, even after adjustment for gender and age (in each case P<0.001). Children with the greatest extent of exercise achieve the highest MQ (P=0.035). SUMMARY:: Overweight/obesity is associated with a poorer body gross motor development and endurance performance. On the other hand, an active lifestyle is positively correlated with a better gross motor development in first-grade children. Therefore, to prevent the negative consequences of physical inactivity and overweight/obesity early intervention to support exercise and movement is recommended.International Journal of Obesity (2004) 28, 22-26. doi:10.1038/sj.ijo.0802428 Published online 2 December 2003
Moderate physical exercise: a simplified approach for ventricular rate control in older patients with atrial fibrillation.
J Plisiene, A Blumberg, G Haager, C Knackstedt, J Latsch, C Norra, M Arndt, S Tuerk, N Heussen, M Kelm, H G Predel, P Schauerte
Department of Cardiology, Pneumology, Vascular Medicine, RWTH University Aachen, Pauwelstrasse 30, 52072, Aachen, Germany.
AIMS This prospective pilot-study was performed to assess whether regular moderate physical activity elevates the parasympathetic tone to the atrio-ventricular node and decreases VR during permanent AF. BACKGROUND Adequate ventricular rate (VR) control in patients with permanent atrial fibrillation (AF) is not easy to accomplish. METHODS 10 patients (mean age 59 +/- 10 years) with permanent AF (duration: 10 +/- 8 years) underwent moderate physical exercise adjusted to their individual physical capability (45 min walking/jogging twice a week). To analyze VR control physical exercise tests and Holter-ECG recordings were performed before and after 4 months. In addition, stepwise lactate tests and psycho-pathometric examinations were obtained. RESULTS After 4 months of training, there was a trend toward a decrease of mean VR in 24 h Holter-ECGs by 12% from 76 +/- 20 to 67 +/- 12 bpm (P = 0.05) while there was no significant decrease of the minimal VR (38 +/- 8 vs. 36.3 +/- 4.5 bpm, P = 0.54). At a lactate threshold of 2 mmol/l there was a trend towards an increase of the running speed from 105 +/- 11 to 116 +/- 12 m/min (P = 0.05). A significant VR decrease of 8%(range 5-10%) was observed at almost all exercise levels during exercise treadmill testing. Increases of exercise capacity and decreases of VR were accompanied by subjective improvements of health perception. CONCLUSION Regular moderate physical activity decreases VR at rest and during exercise while increasing exercise capacity. Physical training should be taken into account for ventricular rate control during AF.
Long-term endurance exercise decreases antiangiogenic endostatin signalling in overweight men aged 50-60 years.
K Brixius, S Schoenberger, D Ladage, H Knigge, G Falkowski, M Hellmich, C Graf, J Latsch, G L Montie, G L Prede, W Bloch
Department of Molecular and Cellular Sport Medicine, German Sport University, Cologne, Germany. firstname.lastname@example.org
BACKGROUND Endurance training may decrease the risk of coronary artery disease. It has been speculated that these effects may be due to an exercise-induced stimulation of angiogenesis. The underlying mechanisms are not yet clear. Therefore, using ELISA, we investigated the plasma level of vascular endothelial growth factor (VEGF, angiogenic factor) and endostatin (antiangiogenic factor) in a group of untrained men aged 50-60 years with obesity. METHODS All men were randomised into a "running" group (training 3 times/week, 60 min each, n = 7), a "cycling" group ( training 3 times/week, 90 min each, n = 7) and a sedentary control group ( n = 7). Both training groups worked at moderate intensity (2-4 mmol/l lactate). The intervention had a duration of 6 months. Before and after this period, blood samples were taken from the participants at rest and they underwent a medical investigation. RESULTS Body mass index (BMI), systolic and diastolic blood pressure, and plasma levels of VEGF and endostatin were comparable in all three groups. Endurance training significantly reduced BMI in both exercise groups (mean (SEM) before v after 29.7 (0.7) v 29.1 (0.6) kg/m2 and 31.1 (0.7) v 30.1 (0.9) kg/m2 for the running and cycling groups respectively) but not in the control group (30.0 (1.0) v 30.2 (0.8) kg/m2). Endurance training did not influence VEGF plasma level (before v after 1.3 (0.4) v 1.5 (0.2) ng/ml for the running group; 1.6 (0.3) v 1.5 (0.2) ng/ml for the cycling group; and 2.5 (0.6) v 2.1 (0.7) ng/ml for the control group). Plasma level of endostatin was significantly reduced in both exercise groups (mean (SEM) before v after: 20.9 (1.6 v 17.5 (1.0) ng/ml and 21.3 (1.4 v 18.0 (1.6) ng/ml for the running and cycling groups respectively) but not in controls (19.7 (1.3 v 17.7 (1.1 ng/ml). CONCLUSIONS Endurance training may reduce the antiangiogenic mechanisms in men aged 50-60 years by reducing endostatin plasma level and this may subsequently decrease the risk of cardiovascular disease.
Integrated effects of the vasodilating beta-blocker nebivolol on exercise performance, energy metabolism, cardiovascular and neurohormonal parameters in physically active patients with arterial hypertension.
H G Predel, W Mainka, W Schillings, H Knigge, J Montiel, J Fallois, R Agrawal, T Schramm, C Graf, B M Giannetti, B Bjarnason-Wehrens, U Prinz, R E Rost
Institute of Cardiology and Sports Medicine, German Sports University, Cologne, Germany. Predel@hrz.dshs_koeln.de
OBJECTIVE The present study was designed to investigate the integrated effects of the beta-1-selective blocker with vasodilator properties, nebivolol, on systemic haemodynamics, neurohormones and energy metabolism as well as oxygen uptake and exercise performance in physically active patients with moderate essential hypertension (EH). DESIGN AND METHODS Eighteen physically active patients with moderate EH were included: age: 46.9 +/- 2.38 years, weight: 83.9 +/- 2.81 kg, blood pressure (BP): 155.8 +/- 3.90/102.5 +/- 1.86 mm Hg, heart rate: 73.6 +/- 2.98 min(-1). After a 14-day wash-out period a bicycle spiroergometry until exhaustion (WHO) was performed followed by a 45-min submaximal exercise test on the 2.5 mmol/l lactate-level 48 h later. Before, during and directly after exercise testing blood samples were taken. An identical protocol was repeated after a 6-week treatment period with 5 mg nebivolol/day. RESULTS Nebivolol treatment resulted in a significant (P < 0.01) decrease in systolic and diastolic BP and heart rate at rest and during maximal and submaximal exercise. Maximal physical work performance, blood lactate and rel. oxygen uptake (rel. VO(2)) before and after nebivolol treatment at rest and during maximal and submaximal exercise remained unaltered. Free fatty acid, free glycerol, plasma catecholamines, beta-endorphines and atrial natriuretic peptide (ANP) increased before and after treatment during maximal and submaximal exercise but remained unaltered by nebivolol treatment. In contrast, plasma ANP levels at rest were significantly higher in the presence of nebivolol, endothelin-1 levels were unchanged. CONCLUSIONS Nebivolol was effective in the control of BP at rest and during exercise in patients with EH. Furthermore, nebivolol did not negatively affect lipid and carbohydrate metabolism and substrate flow. The explanation for the effects on ANP at rest remain elusive. This pharmacodynamic profile of nebivolol is potentially suitable in physically active patients with EH.
[Ambulatory phase II cardiac rehabilitation (Cologne model). 3 year outcome after completion of the intervention].
Institut für Kreislaufforschung und Sportmedizin, Deutschen Sporthochschule Köln. email@example.com
[Phase II ambulatory cardiac rehabilitation (Cologne model). 3 year results after conclusion of the intervention].
Deutsche Sporthochschule, Institut für Kreislaufforschung und Sportmedizin, Köln.
BASELINE: Of a total of 101 patients with CAD who participated in an ambulatory cardiac rehabilitation program (ACR)("Cologne model") between 1992 and 1994, 76 (75.2%) were examined 36 months after concluding ACR. RESULTS: The significant improvement in exercise tolerance from 118.4 +/- 30.1 to 131.9 +/- 34.1 W achieved with the ACR was maintained at the 3-year examination. ACR also significantly decreased plasma cholesterol levels from 228.9 +/- 48.3 to 211.7 +/- 37.0 mg%; 3 years after ACR the corresponding figures were 219.1 +/- 39.3 mg%. In the high-risk group the significant reduction in plasma cholesterol levels from 265 +/- 43.6 to 231.9 +/- 35.4 mg% observed immediately after ACR was maintained over the three-year period (234.6 +/- 37.7 mg%). Similar patterns were observed for other parameters of lipid metabolism. Before the cardiac event 63.2% of the patients smoked; at the 3-year examination the percentage was 30.3%. Before ACR, 73.7% of the patients were gainfully employed. Within the first 6 months after ACR, 71.4% returned to work, and this percentage increased to 73.2% after one year. Three years later, 64.3% were still working. DISCUSSION: The results demonstrate that the lifestyle changes achieved with 4-weeks of ACR may, at least in part, be maintained over a period of 36 months.
Herz. 1999 Apr ;24 Suppl 1 :73-9 10372312
[Clinical follow-up 6 months after ambulatory/partial inpatient after-care rehabilitation. Further results of the Cologne model of ambulatory cardiac phase II rehabilitation].
Institut für Kreislaufforschung und Sportmedizin der Deutschen Sporthochschule Köln. Bjarnason@hrz.dshs-koeln.de
Three hundred and thirty patients with coronary artery disease (CAD)(288 men, 42 women, age of 55.5 +/- 10.0 years) participated in a 4-week ambulatory cardiac rehabilitation program (ACR)(Table 1). The cardiovascular indication for ACR was in 229 cases a myocardial infarction. In 101 patients a CAD with invasive revascularization but without a history of MI was present. In 92 patients with myocardial infarction additionally an invasive revascularization was performed. Eighty-three patients were included after a CABG-procedure (Tables 2 to 5). Six months after the ACR 290 (87.9%) patients presented for clinical reevaluation. In 235 (81.0%) of the 290 examined patients the cardiovascular diagnosis was unaltered. In the first 6 months after ACR in 76 (26.2%) patients a coronarography was performed, in 44 patients a restenosis was diagnosed. In 36 patients an additional invasive procedure (in 28 patients a PTCA, in 5 patients with additional stent-implantation, in 1 case with rotablation, in 8 patients CABG) was performed. In 1 patients a pace-maker was implanted. Since the ACR 1 patient experienced a myocardial infarction and 2 a recurrent myocardial infarction. In 1 patient myocardial fibrillation occurred. Totally, 70 patients (24.1%) required stationary-hospital treatment during the first 6 months after ACR (Table 6). In 11 cases an acute admission to hospital treatment because of cardiovascular reasons was documented. The majority of the hospital admission was elective, because of diagnostic or therapeutic procedures. In 6 patients a CABG-surgery was performed. In approximately 80% of the patients the cardiovascular status was stable during the first 6 months after ACR. Though 24.1% of the patients required stationary hospital treatment, the majority of the admissions was elective of interest, there was a high rate of hospital admissions in the PTCA-group in combination with recoronarographies and revascularization because of early reocclusion.
Herz. 1999 Apr ;24 Suppl 1 :44-56 10372308
[Outcome of a four-week ambulatory cardiac rehabilitation (phase II) on cardiovascular risk factors, physical fitness and occupational reintegration in patients after myocardial infarct, dilatation treatment and heart operation].
Ambulantes kardiologisches Rehabilitationszentrum, Köln. firstname.lastname@example.org
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.
[Ambulatory cardiac phase II rehabilitation--"the Cologne model"--including 3-year-outcome after termination of rehabilitation].
Institut für Kreislaufforschung und Sportmedizin der Deutschen Sporthochschule Köln. email@example.com
From January 1992 until December 1994 the Cologne model of ambulant cardiac rehabilitation (ACR) in the greater area of Cologne, Germany, was performed and is still in progress. In Germany until 1992 the cardiac rehabilitation was exclusively performed stationary. The objective of the "Cologne model" was to evaluate, whether the transfer of the stationary cardiac rehabilitation programs into the ambulatory setting is achievable without deficits in efficiency, safety and overall quality. The results obtained are intended to serve for standardization and quality control of future ambulatory cardiac rehabilitation programs in Germany. From 1992 to 1994 108 patients (94 men, 14 women; 52.3 +/- 8.0 years old) with coronary artery disease (CAD) which were compatible with the criteria of the "Cologne model"(Table 1) participated in the 4-week ACR. The indications for inclusion into the ACR were in 74 cases a myocardial infarction (MI), in 34 cases CAD without MI, but with PTCA/stent-procedure (Table 3). Seven patients discontinued the ACR prematurely, 2 patients because of cardiovascular reasons. Reasons for the preference of the ambulatory over a stationary cardiac rehabilitation program were in 40.6% of the patients refusal of "hospital ambience", in 43.6% familiar or in 12.9% professional reasons. During the 4-week ACR patients participated in a mean of 72.9 +/- 6.7 hours of therapy (Table 4). As a result of the ACR exercise tolerance increased highly significantly (**) from 116.4 +/- 28.8 to 129.9 +/- 34.6 watt). This improvement was maintained at the 1- and 3-year control (128.7 +/- 35.8**) examinations (Tables 5 and 7). One year after ACR 77% of the patients stated to be physically active in ambulatory heart groups (AHG)(27.6%) or on their own (49.4%). Three years after ACR the rate of regularly physically active patients still was 59.2%. Furthermore, as a result of ACR the dietary behavior was changed significantly. There was a reduction in the consumption of lipids by 20.8%, saturated fatty acids by 30.7% and of cholesterol by 30.5%. The plasma concentrations of cholesterol decreased from 231 +/- 49.8 to 213.2 +/- 35.9 mg%**. Six (and 12) months after ACR they increased again to 225.6 +/- 39.4 mg%. Three years after ACR the mean cholesterol level was 219.1 +/- 39.3 mg%. In the high risk group (cholesterol at the initial visit > 220 mg%) cholesterol levels were reduced from 266 +/- 44 to 232 +/- 31.9 mg%**. Six and 12 months after ACR they were 239.7 +/- 35.8 mg% and 245.8 +/- 32.6 mg%, respectively,(Tables 6 and 7) and still significantly lower than before ACR, though only 19% of the patients were treated with lipid lowering agents. Three years after ACR cholesterol were 234.6 +/- 37.7 mg%** in the high-risk group. 34.2% of the patients received lipid lowering agents. Mean body weight remained unaltered over the 3-year period. Smoking behavior was not altered significantly during the 4-week ACR. However, before the cardiovascular event 67.3% of the patients had smoked cigarettes. At the beginning and at the end of ACR 20.8% of the patients still smoked. During the ACR the number of smoked cigarettes was reduced significantly from 32.4 +/- 15.2 to 6.9 +/- 5.2 cigarettes per day. One year after ACR 23% of the patients were smokers, 3 years after ACR the percentage of smokers increased to 30.3%. Before ACR 73.3% of the patients were still working. During the first 6 months after ACR 68.2% returned to work and the percentage increased to 73% in the following 6 months. The results demonstrate that it is achievable to transfer the contents of the established stationary cardiac rehabilitation programs into the ambulatory setting without loss of efficiency, safety and overall quality. It is further confirmed, that it is necessary to continuously evaluate the results of the cardiac rehabilitation program on a long-term basis.(ABSTRACT TRUNCATED)
[Improvement of physical performance and aerobic capacity mediated by a novel 4--week ambulatory cardiac rehabilitation program]
Institut für Kreislaufforschung und Sportmedizin, Deutsche Sporthochschule Köln.
During a 4-week ambulatory cardiac rehabilitation program, 262 patients with coronary artery disease (CAD), 235 men and 27 women, 53.6 +/- 10.2 years, performed 30.5 +/- 2.9 exercise units. Before and after the rehabilitation program exercise, capacity was assessed by bicycle ergometry. There was a significant (p < 0.001) increase in the maximum exercise capacity at the end of the program (105.3 +/- 32.3 vs. 121.9 +/- 37.3 W). Physical work capacity on the 2.0 mmol lactate level improved (p < 0.001) from 72.2 +/- 23.5 to 86.4 +/- 25.8 W, on the 2.5 mmol/l level (p < 0.001) from 83.5 +/- 23.2 to 97.4 +/- 26.4 W, and on the 3.0 mmol/l level (p < 0.001) from 93.1 +/- 23.0 to 106.6 +/- 26.1 W. Despite enhanced performance, heart rate remained unaltered on the 2.0, 2.5, and 3.0 mmol/l lactate level. Furthermore, ergometric performance on predefined heart rate levels was significantly (p < 0.001) increased: 85/min: from 56.0 +/- 24.1 to 65.8 +/- 24.5 W, 90/min: from 62.0 +/- 27.3 to 71.2 +/- 26 W; 95/min: from 67.2 +/- 26.4 to 77.5 +/- 27.6 W; 100/min: from 71.1 +/- 29.6 to 80.6 +/- 28.1 W; 105/min: from 69.8 +/- 26.2 to 81.9 +/- 28.2 W and 110/min: from 73.6 +/- 28.9 to 90.4 +/- 29.4 W. The results demonstrate that physical performance in patients with CAD was improved by our novel ambulatory cardiac rehabilitation program. This improvement included an increase in maximum as well as endurance work capacity; furthermore, this increase was accompanied by a decrease in resting and exercise heart rates. The results demonstrate an absolute increase of physical performance, more importantly an increase of physical performance at defined lactate levels in the presence of unchanged heart rates mediated by the rehabilitation program. Thus, this increase was independent of motivational factors in the patients and/or the investigators during the re-exercise test. On the contrary, our data demonstrate that it is based on an improvement of aerobic endurance capacity associated with a therapeutically beneficial significant decrease of heart rate for a defined workload. The effects were independent of pharmacological influences (e.g., beta-receptor antagonists). These findings are of clinical importance with respect to reduction of myocardial oxygen consumption in patients with CAD.
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Eur J Prev Cardiol. 2012 Oct 30;: 23111536
Efficacy of a long-term secondary prevention programme following inpatient cardiovascular rehabilitation on risk and health-related quality of life in a low-education cohort: a randomized controlled study.
Wolfgang Mayer-Beger, Dusan Simic, Jawad Mahmoodzad, Ralph Burtscher, Martin Kohlmeyer, Birgitta Schwitalla, Marcus Redaèlli
Centre for Cardiovascular Rehabilitation, Leichlingen, Germany.
Objective: The aim of this study was to evaluate the efficacy of a long-term secondary prevention programme following inpatient cardiovascular rehabilitation on cardiovascular risk and health-related quality of life in a cohort of middle-aged (≤58 years) coronary artery disease (CAD) patients of low educational level compared to usual care.Design and methods: The study included 600 patients with CAD, with 271 in the intervention group (IG) and 329 in the control group (CG). The average age was nearly 50 years in both groups, nearly 90% were male, and 77% had less than 10 years of school education. No significant differences existed between the groups at baseline. Both groups had a 3-week comprehensive cardiovascular inpatient rehabilitation programme at the beginning, the intervention consisted of one further rehabilitation session in hospital after 6 months and regular telephone reminders over a period of 36 months. Analyses were conducted on an intention-to-treat basis. To evaluate the individual risk level, we used the PROCAM score and intima-media thickness (IMT) was measured at the common carotid artery on both sides following international standards. Health-related quality of life was assessed with the EUROQOL and HADS.Results: Patients in the IG showed better 3-year risk profile outcomes. The PROCAM score increased by 3.0 (IG) and by 3.7 (CG) from the beginning to after 3 years (p > 0.05 intention-to-treat). The average IMT increased by 0.04 mm in the CG and was reduced by 0.03 mm in the IG (p = 0.014 for the difference). The IG had a significant improvement in health-related quality of life. Mortality, myocardial infarction, and stroke were not different although 'other cardiac events'(cardiac surgery or intervention) were significantly lower in the IG than the CG patients (p < 0.05).Conclusion: This long-term secondary prevention programme with inpatient rehabilitation at the beginning and telephone reminder for a 3-year period was successful. There were significant differences in health-related quality of life between the IG and CG, despite the relatively positive outcomes in the CG. In this low-education (predominantly male), middle-aged cohort, the positive impact on cardiovascular risk was pronounced in the high-risk subgroup (PROCAM 10-year risk 10-40%).
Cardiology Division, GRB-800, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA.
Vitamin D deficiency is a common condition that has well-documented effects on musculoskeletal health. A growing body of literature has related vitamin D deficiency to other chronic disorders, including cardiovascular disease. Several plausible biological mechanisms have been postulated to explain this association, including the effect of poor vitamin D status on intermediate risk factors (eg, hypertension and diabetes), neurohormonal activation, inflammation, and cardiac remodeling. These mechanisms have been explored in experimental and animal studies, as well as several small interventional studies. The results of the controlled trials have not been conclusive to date. In this review, we summarize the existing studies investigating the effects of vitamin D on cardiovascular health, and propose that additional well-designed, prospective, randomized controlled trials are necessary to delineate the appropriate role of vitamin D supplementation in reducing the burden of cardiovascular disease.
Trials. 2011 ;12 :209 21943067
DIABRISK-SL prevention of cardio-metabolic disease with life style modification in young urban Sri Lankan's--study protocol for a randomized controlled trial.
Mahen Wijesuriya, Martin Gulliford, Laksha Vasantharajah, Giancarlo Viberti, Luigi Gnudi, Janaka Karalliedde
Diabetes Association of Sri Lanka, National Diabetes Centre, Colombo, Sri Lanka.
BACKGROUND Urban South-Asian's are predisposed to early onset of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). There is an urgent need for country specific primary prevention strategies to address the growing burden of cardio-metabolic disease in this population. The aim of this clinical trial is to evaluate whether intensive (3-monthly) lifestyle modification advice is superior to a less-intensive (12 monthly; control group) lifestyle modification advice on a primary composite cardio-metabolic end point in 'at risk' urban subjects aged between 5-40 years. METHODS/DESIGN This is an open randomised controlled parallel group clinical trial performed at a single centre in Colombo, Sri-Lanka. A cluster sampling strategy was used to select a large representative sample of subjects aged between 5-40 years at high risk of T2DM and CVD for the intervention study. We have screened 23,298 (males 47% females 53%) healthy subjects for four risk factors: obesity, elevated waist circumference, family history of diabetes and physical inactivity, using a questionnaire and anthropometry. Those with two or more risk-factors were recruited to the intervention trial. We aim to recruit 4600 subjects for the intervention trial. The primary composite cardio-metabolic end point is; new onset T2DM, impaired glucose tolerance, impaired fasting glycaemia, new onset hypertension and albuminuria, following 5 years of intervention. The effect of the intervention on pre-specified secondary endpoints will also be evaluated. The study will be conducted according to good clinical and ethical practice, data analysis and reporting guidelines. DISCUSSION DIABRISK-SL is a large population based trial to evaluate the prevalence of diabetes, pre-diabetes and cardio-metabolic risk factors among young urban Sri-Lankans and the effect of a primary prevention strategy on cardio-metabolic disease end points. This work will enable country specific and regional cardio-metabolic risk scores to be derived. Further if the proposed intervention is successful the results of this study can be translated and implemented as a low-cost primary prevention tool in Sri-Lanka and other low/middle income developing countries. TRIAL REGISTRATION The trial is registered with the World Health Organisation and Sri-Lanka clinical trial registry number SLCTR/2008/003.
J Nephrol. ;25 (3):437-40 21928233
A prospective, multicenter, randomized, controlled study: the correction of metabolic acidosis with use of bicarbonate in Chronic Renal Insufficiency (UBI) Study.
SOC di Nefrologia, A. Landolfi Hospital, Solofra, Avellino, Italy. firstname.lastname@example.org
BACKGROUND A Cochrane Collaboration review (Roderick, Cochrane Data base of systemic reviews 2007, DOI 10.1002/14651858.CD0018.90.pub3) reported that there was no evidence for correction of acidosis by sodium bicarbonate in pre-end-stage renal disease (ESRD) patients, and concluded that randomized controlled trials (RCTs) are necessary to evaluate the benefits and harms of correcting metabolic acidosis in pre-ESRD patients. We wanted to evaluate if the administration of alcaly (mainly sodium bicarbonate) is able to significantly modify renal death and to reduce mortality due to cardiovascular events. METHODS This is a proposal for a multicenter, prospective, cohort, randomized and controlled study. We will randomize 600 patients with chronic kidney disease (CKD) stages 3b and 4; 300 of these patients will be included in the bicarbonate study group (Bic), in which levels of bicarbonate should be kept >24 mEq/L; the other 300 patients will be included in the usual-treatment group (no-Bic). RESULTS The aim of the research protocol is to demonstrate whether the optimal correction of uremic acidosis (with administration of sodium bicarbonate or of any other alkalinizing agent - e.g., sodium citrate) reduces renal and cardiovascular mortality. CONCLUSIONS In conclusion, the Work Group on Conservative Therapy for Chronic Renal Insufficiency proposes this prospective, multicenter, cohort, randomized, controlled study to evaluate the effects of correction of acidosis on the progression of the kidney disease evaluated as renal death in ESRD patients.
Value of primordial and primary prevention for cardiovascular disease: a policy statement from the American Heart Association.
William S Weintraub, Stephen R Daniels, Lora E Burke, Barry A Franklin, David C Goff Jr, Laura L Hayman, Donald Lloyd-Jones, Dilip K Pandey, Eduardo J Sanchez, Andrea Parsons Schram, Laurie P Whitsel
The process of atherosclerosis may begin in youth and continue for decades, leading to both nonfatal and fatal cardiovascular events, including myocardial infarction, stroke, and sudden death. With primordial and primary prevention, cardiovascular disease is largely preventable. Clinical trial evidence has shown convincingly that pharmacological treatment of risk factors can prevent events. The data are less definitive but also highly suggestive that appropriate public policy and lifestyle interventions aimed at eliminating tobacco use, limiting salt consumption, encouraging physical exercise, and improving diet can prevent events. There has been concern about whether efforts aimed at primordial and primary prevention provide value (ie, whether such interventions are worth what we pay for them). Although questions about the value of therapeutics for acute disease may be addressed by cost-effectiveness analysis, the long time frames involved in evaluating preventive interventions make cost-effectiveness analysis difficult and necessarily flawed. Nonetheless, cost-effectiveness analyses reviewed in this policy statement largely suggest that public policy, community efforts, and pharmacological intervention are all likely to be cost-effective and often cost saving compared with common benchmarks. The high direct medical care and indirect costs of cardiovascular disease-approaching $450 billion a year in 2010 and projected to rise to over $1 trillion a year by 2030-make this a critical medical and societal issue. Prevention of cardiovascular disease will also provide great value in developing a healthier, more productive society.
Division of Cardiology, Albert Einstein Medical Center, Philadelphia, Pennsylvania 19111, USA.
Cardiac rehabilitation is increasingly recognized as an essential part of the continuum of care for patients with cardiovascular disease. The discipline has evolved over the last 15 yrs to reflect the importance of targeted initiatives in the management of cardiovascular risk factors. Changes in program scope have broadened to shift the emphasis away from primarily focusing on exercise therapy to embracing a comprehensive secondary prevention strategy addressing the multiple medical, exercise, nutritional, and behavioral factors that place a patient at increased risk of a subsequent cardiac event. Cardiac rehabilitation is a class I recommendation in most current cardiovascular clinical practice guidelines. Despite the large body of literature verifying the sizeable morbidity and mortality benefits, cardiac rehabilitation services are vastly underused. The implementation of recent performance measures will provide the potential to boost referral to, enrollment in, and completion of cardiac rehabilitation programs. The goals, core components, benefits, risks, and outcome measures of cardiac rehabilitation will be reviewed.
Am Heart J. 2011 Jun ;161 (6):1171-8 21641365
Long-term effects of fosinopril and pravastatin on cardiovascular events in subjects with microalbuminuria:Ten years of follow-up of Prevention of Renal and Vascular End-stage Disease Intervention Trial (PREVEND IT).
Frank P Brouwers, Folkert W Asselbergs, Hans L Hillege, Rudolf A de Boer, Ron T Gansevoort, Dirk J van Veldhuisen, Wiek H van Gilst
Department of Cardiology, Thoraxcenter, Universitair Medical Center Groningen, University of Groningen, The Netherlands. email@example.com
BACKGROUND The PREVEND IT investigated whether treatment targeted at lowering urinary albumin excretion (UAE) would reduce adverse cardiovascular events. We obtained extended follow-up data to approximately 10 years to investigate the long-term effects of fosinopril 20 mg and pravastatin 40 mg on cardiovascular outcomes in subjects with UAE >15 mg per 24 hours. METHODS The original PREVEND IT consisted of 864 participants and 839 survivors after 4 years. For every survivor, the primary end point determined by the combined incidence of cardiovascular mortality and hospitalization for cardiovascular morbidity was registered in several national databases and electronic hospital systems. RESULTS Mean total follow-up of the extended PREVEND IT was 9.5 years (range 9.4-10.7 years). Four years of treatment with fosinopril was not associated with a reduction in the primary end point compared with placebo (hazard ratio 0.87, 95% CI 0.61-1.24 [P =.42]) during long-term follow-up. After 9.5 years, subjects with a baseline UAE in the upper quintile (>50 mg/24 hours) had a total event rate of 29.5% and were at a higher risk for developing cardiovascular disease compared with less UAE (hazard ratio 2.03, 95% CI 1.38-2.97 [P ≤ .01]). In addition, 4 years of fosinopril treatment resulted in a risk reduction of 45%(95% CI 6%-75%[P =.04]) in this group compared with placebo. Subjects originally assigned to pravastatin had no overall risk reduction in the primary end point (P =.99). CONCLUSIONS Elevated UAE is associated with increased cardiovascular mortality and morbidity after 9.5 years of follow-up, with a doubling of the risk if the UAE is >50 mg per 24 hours. In this group, the benefits of 4-year treatment with fosinopril were sustained during posttrial follow-up for cardiovascular mortality and morbidity. We propose that UAE be used to estimate risk in the general population and that large clinical trials be designed to confirm the hypothesis that angiotensin-converting enzyme-inhibitor treatment may be beneficial in patients with mildly elevated UAE despite the absence of other comorbidities.
M A J van den Broek, R M van Dam, G J P van Breukelen, M H Bemelmans, E Oussoultzoglou, P Pessaux, C H C Dejong, N Freemantle, S W M Olde Damink
Department of Surgery, Maastricht University Medical Centre, Maastricht University, Maastricht, The Netherlands.
BACKGROUND The feasibility of randomized controlled trials (RCTs) in liver surgery using a single-component clinical endpoint is low as such endpoints require large sample sizes owing to their low incidence. A liver surgery-specific composite endpoint (CEP) could solve this problem. The aim of this study was to develop a liver surgery-specific CEP with well-defined components. METHODS Components of a liver surgery-specific CEP were selected based on a systematic literature search and consensus among 28 international hepatopancreatobiliary (HPB) surgeons. As an example, two prospective cohorts of patients who had undergone liver surgery in high-volume HPB centres were used to assess the event rate and effect of implementing a liver surgery-specific CEP. RESULTS Components selected for the liver surgery-specific CEP were ascites, postresectional liver failure, bile leakage, intra-abdominal haemorrhage, intra-abdominal abscess and operative mortality, all with a Clavien-Dindo grade of at least 3 and occurring within 90 days after initial surgery. The incidence of this liver surgery-specific CEP was 19.2 per cent in one cohort and 10.7 per cent in the other. These rates led to an approximately twofold reduction in the theoretical sample size required for an adequately powered RCT in liver surgery using the CEP as primary endpoint. CONCLUSION The proposed liver surgery-specific CEP consists of ascites, postresectional liver failure, bile leakage, intra-abdominal haemorrhage, intra-abdominal abscess and operative mortality. It has a considerably higher event rate than any of its components. Its use as the primary endpoint will increase the feasibility and comparability of RCTs in liver surgery.
Unit of Public Health, Epidemiology and Biostatistics, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom. firstname.lastname@example.org
In this systematic review, the authors aimed to assess the effectiveness of community programs for prevention of cardiovascular disease (CVD). They searched numerous electronic databases (CDSR, DARE, HTA, EED, and CENTRAL via the Cochrane Library, MEDLINE, MEDLINE In Process, EMBASE, CINAHL, PsycINFO, HMIC, and ASSIA) and relevant Web sites from January 1970 to mid-July 2008. Controlled studies of community programs for the primary prevention of CVD were included. Net changes in CVD risk factors were used to generate an overall index for net change in 10-year CVD risk. The authors identified 36 relevant community programs that took place between 1970 and 2008. These programs were multifaceted interventions employing combinations of media, screening, and counseling activities and environmental changes and were primarily evaluated using controlled before-after studies. In 7 studies, investigators reported changes in CVD/total mortality rates, and in 5 they reported net changes. In all cases, these net changes were positive but were largely nonsignificant. In 22 studies, investigators reported changes in physiologic CVD risk factors, and there was a positive trend in the calculated CVD risk score. The average net reduction in 10-year CVD risk was 0.65%. Community programs for CVD prevention appear to have generally achieved favorable changes in overall CVD risk and, with adaptation to current circumstances, deserve continued consideration as possible approaches to preventing CVD.
Cardiology Division, University of Massachusetts Medical School, Worcester, USA.