title: The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial.
abstract: BACKGROUND
  The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established.The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention programme of 6 months duration aimed at maximum reduction of cardiovascular risk factors in patients with cardiovascular disease (CVD) compared with usual care.
  
  
  METHODS
  A single centre, two arm, parallel group randomised controlled trial was performed. Patients with stable established CVD and at least one lifestyle-related risk factor were recruited from the vascular and cardiology outpatient departments of the university hospital. Blocked randomisation was used to allocate patients to the intervention (n = 71) or control group (n = 75) using an on-site computer system combined with allocations in computer-generated tables of random numbers kept in a locked computer file. The intervention group received the comprehensive lifestyle intervention offered in a specialised outpatient clinic in addition to usual care. The control group continued to receive usual care. Outcome measures were the lifestyle-related cardiovascular risk factors: smoking, physical activity, physical fitness, diet, blood pressure, plasma total/HDL/LDL cholesterol concentrations, BMI, waist circumference, and changes in medication.
  
  
  RESULTS
  The intervention led to increased physical activity/fitness levels and an improved cardiovascular risk factor profile (reduced BMI and waist circumference). In this setting, cardiovascular risk management for blood pressure and lipid levels by prophylactic treatment for CVD in usual care was already close to optimal as reflected in baseline levels. There was no significant improvement in any other risk factor.
  
  
  CONCLUSIONS
  Even in CVD patients receiving good clinical care and using cardioprotective drug treatment, a comprehensive lifestyle intervention had a beneficial effect on some cardiovascular risk factors. In the present era of cardiovascular therapy and with the increasing numbers of overweight and physically inactive patients, this study confirms the importance of risk factor control through lifestyle modification as a supplement to more intensified drug treatment in patients with CVD.
  
  
  BACKGROUND
  ISRCTN69776211 at http://www.controlled-trials.com.
authors.affiliation: Department of Health Sciences and the EMGO + Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085, 1081HV, Amsterdam, The Netherlands. h.ijzelenberg@vu.nl
authors.forename: Wilhelmina
authors.initials: W
authors.lastname: Ijzelenberg
authors.forename: Irene M
authors.initials: IM
authors.lastname: Hellemans
authors.forename: Maurits W
authors.initials: MW
authors.lastname: van Tulder
authors.forename: Martijn W
authors.initials: MW
authors.lastname: Heymans
authors.forename: Jan A
authors.initials: JA
authors.lastname: Rauwerda
authors.forename: Albert C
authors.initials: AC
authors.lastname: van Rossum
authors.forename: Jaap C
authors.initials: JC
authors.lastname: Seidell
mesh_terms: D000368:Aged; D000553:Ambulatory Care; D015415:Biomarkers / Q000097:blood; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003131:Combined Modality Therapy; D003376:Counseling; D004032:Diet / Q000009:adverse effects; D018752:Diet, Fat-Restricted; D038441:Diet, Mediterranean; D015444:Exercise; D005260:Female; D015438:Health Behavior; D006785:Hospitals, University; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010044:Outpatient Clinics, Hospital; D010349:Patient Compliance; D018570:Risk Assessment; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012907:Smoking / Q000009:adverse effects; D016540:Smoking Cessation; D000074606:Smoking Prevention; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D015415:Biomarkers; D002317:Cardiovascular Agents; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL