A Randomized Controlled Trial of an Extensive Lifestyle Management Intervention (ELMI) Following Cardiac Rehabilitation: Study Design and Baseline Data

Background: Cardiac rehabilitation programs (CRP) represent comprehensive interventions thatare typically limited to four months. Following completion of CRP, it appears that risk factors andlifestyle behaviours may deteriorate. The Extensive Lifestyle Management Intervention (ELMI)Following Cardiac Rehabilitation trial will investigate the benefits of a randomized intervention toprevent these adverse changes.Methods: Patients with ischemic heart disease (IHD) were randomized following a standard CRPto the ELMI or to usual care. The ELMI program is a case-managed intervention aimed atindividualizing risk factor and lifestyle management based on current treatment guidelines. Theprogram consists of cardiac rehabilitation sessions, telephone follow-up and risk factor and lifestylecounselling sessions. Health professionals work with participants using behavioural counselling andcommunications with participants' family physicians. Usual care participants return to their familyphysicians' care, and come to the study clinic only to undergo annual outcomes assessment. Theprimary outcome is change in IHD global risk after four years. Secondary outcomes includecombined cardiovascular events, health care utilization, lifestyle adherence, quality of life and riskfactors.Results: Over 28 months, 302 men and women were randomized. This represented 29% of thetotal population screened. The average age of study participants is 64 years, 18% are women, 53%have had a previous myocardial infarction, 73% have undergone previous revascularization and 20%have diabetes mellitus. Ischemic heart disease risk factors for the entire cohort improvedsignificantly after subjects had gone through previous CRPs. Baseline risk factors, lifestylebehaviours and medications were similar between the groups.