OPTImal CArdiac REhabilitation (OPTICARE) Following Acute Coronary Syndromes

The objective is to investigate whether in acute coronary syndrome patients the cardiac risk profile will improve with 2 new extended cardiac rehabilitation interventions and if these patients maintain healthier life style habits and a more active life style compared to patients randomized to standard cardiac rehabilitation.

Rationale: Throughout the western world, healthy life style management is becoming increasingly important. Therefore, secondary prevention with an emphasis on lifestyle adjustments should be the cornerstone of modern cardiac rehabilitation (CR). This study may demonstrate the benefits of extended CR with respect to achieving optimal long term secondary prevention goals.

Objective: The objective is to investigate whether in acute coronary syndrome patients the cardiac risk profile will improve with 2 new extended cardiac rehabilitation interventions (OPTICARE and COACH) and if these patients maintain healthier life style habits and a more active life style compared to patients randomized to standard CR.

Study design: The proposed trial is a singlecenter, multi-disciplinary randomized controlled trial with a 24-month follow-up. In total 1200 patients will be randomized into 3 arms:(1) Standard CR according to the Dutch guidelines; (2) OPTICARE intervention: standard CR and participation in multifactorial lifestyle sessions during rehabilitation and additional sessions at 4, 6 and 12 months and a personalized program to promote an active lifestyle; (3) COACH intervention: standard CR according to the Dutch guidelines followed by 5 telephone delivered coaching sessions starting at 6 weeks intervals (up to 6 months). The enrollment period will be 24 months, the intervention period is 12 months and the duration of the follow-up will be another 12 months. Assessments will take place at 4 time points: at baseline, 12 weeks after inclusion (end standard CR), at 12 and at 24 months.

Study population: Patients referred for standard CR will be included to participate in this trial. ACS patients treated with primary or elective PCI or CABG, with a stable medical condition and providing written informed consent are eligible to participate.

Intervention: OPTICARE intervention: Standard CR and obligation to participate in multifactorial lifestyle and risk factor sessions (medical information, dietary advises, risk factors and emotional advises). Individual sessions and a personalized home-based program to promote an active life style upon instruction of a physiotherapist and physical activity counsellor during and after completion of rehabilitation. If applicable, patients will participate in smoking cessation, dietary and stress management programs. Additional supervised multifactorial lifestyle and risk management training sessions of each 2 hours are provided at 4, 6 and 12 months. COACH intervention: standard CR according to the Dutch guidelines followed by 5 telephone based coaching sessions starting at 6 weeks intervals up to 6 months. The coaching sessions include assertiveness training, goal setting and reassessment.

Main study parameters/endpoints: The main objective is to investigate whether in patients randomized to extended CR (OPTICARE or COACH) cardiac risk profile will be improved, if these patients maintain healthier life style habits and do achieve an increase in daily activity level compared to patients randomized to standard CR.

• Risk Factor Reduction
• Lifestyle Changes

• Other: rehabilitation+telephonic coaching
  intervention starts 2 weeks after ending standard CR and is based on five phonebased coaching sessions at 6 weeks intervals up to 6 months. Each coaching session includes 5 stages: (1) Asking questions to establish patient's knowledge, attitude and beliefs about their risk factors; (2) Explanation and rationale; (3) Assertiveness training; (4) Goal setting; (5) Reassessment.
  Other Name: cardiac rehabilitation
• Other: OPTICARE-B
  standard CR according to the guidelines consisting of (a) 2 times a week exercise program of 1.5 hours during 12 weeks, (b) upon request of the patient: participation in multifactorial lifestyle and risk factor sessions (medical information, dietary advises and emotional advises, information about risk factors, smoking cessation program and stress management sessions).
  Other Name: cardiac rehabilitation
• Other: OPTICARE-C
  (a) standard CR consisting of 2 times a week exercise program of 1.5 hours during 12 weeks. (b) (mandatory) participation in multifactorial lifestyle and risk factor sessions: i.e. 4 sessions of 2 hours each (medical information, dietary advises, risk factors and emotional advises). If applicable, patients will participate in smoking cessation, dietary and stress management programs . (c) Individual sessions and a personalized home-based program to promote an active life style upon instruction of a physiotherapist and physical activity counselor during and after completion of rehabilitation. Activity monitors will be used to provide feedback. (d) Additional compulsory supervised multifactorial lifestyle and risk management training sessions of each 2 hours provided at 4, 6 and 12 months.
  Other Name: cardiac rehabilitation

• Experimental: OPTICARE-A
  Intervention starts 2 weeks after ending standard cardiac rehabilitation (CR) and is based on five phonebased coaching sessions at 6 weeks intervals up to 6 months. Each coaching session includes 5 stages: (1) Asking questions to establish patient's knowledge, attitude and beliefs about their risk factors; (2) Explanation and rationale; (3) Assertiveness training; (4) Goal setting; (5) Reassessment.
  Intervention: Other: rehabilitation+telephonic coaching
• Active Comparator: OPTICARE-B
  Standard CR according to the guidelines consisting of (a) 2 times a week exercise program of 1.5 hours during 12 weeks, (b) upon request of the patient: participation in multifactorial lifestyle and risk factor sessions (medical information, dietary advises and emotional advises, information about risk factors, smoking cessation program and stress management sessions)
  Intervention: Other: OPTICARE-B
• Experimental: OPTICARE-C
  (a) standard CR consisting of 2 times a week exercise program of 1.5 hours during 12 weeks. (b) (mandatory) participation in multifactorial lifestyle and risk factor sessions: i.e. 4 sessions of 2 hours each (medical information, dietary advises, risk factors and emotional advises). If applicable, patients will participate in smoking cessation, dietary and stress management programs . (c) Individual sessions and a personalized home-based program to promote an active life style upon instruction of a physiotherapist and physical activity counselor during and after completion of rehabilitation. Activity monitors will be used to provide feedback. (d) Additional compulsory supervised multifactorial lifestyle and risk management training sessions of each 2 hours provided at 4, 6 and 12 months.
  Intervention: Other: OPTICARE-C

Inclusion Criteria:

• Patients with an acute coronary syndrome treated with primary or elective PCI or coronary surgery (CABG), with a stable medical condition and providing written informed consent are eligible to participate.
• Men and women who signed informed consent.
• Patients are eligible to participate in the study if they are: able to regularly attend a supervised exercise programme and able to complete Dutch language questionnaires.

Exclusion Criteria:

• Patients with heart failure
• Impaired left ventricular function (LVEF<40%)
• Psychic or cognitive impairments
• Severe arrhythmias
• Heart valve disease
• Congenital disease
• Severe co-morbidities which limit the CR (e.g. severe COPD, severe diabetes or locomotive disorder) and patients with an ICD will be excluded.