Maintenance of Gains, Morbidity, and Mortality at 1 Year Following Cardiac Rehabilitation in a Middle-Income Country: A Wait-List Control Crossover Trial

Abstract

Background Despite the epidemic of cardiovascular diseases in middle-income countries, few trials are testing the benefits of cardiac rehabilitation ( CR ). This trial assessed (1) maintenance of functional capacity, risk factor control, knowledge, and heart-health behaviors and (2) mortality and morbidity at 6 months following CR in a middle-income country. Methods and Results Eligible Brazilian coronary patients were initially randomized (1:1:1 concealed) to 1 of 3 parallel arms (comprehensive CR [exercise plus education], exercise-only CR , or wait-list control). The CR programs were 6 months in duration, at which point follow-up assessments were performed. Mortality and morbidity were ascertained from chart and patient or family report (blinded). Controls were then offered CR (crossover). Outcomes were again assessed 6 months later (blinded). ANCOVA was performed for each outcome at 12 months. Overall, 115 (88.5%) patients were randomized, and 62 (53.9%) were retained at 1 year. At 6 months, 23 (58.9%) of those 39 initially randomized to the wait-list control elected to attend CR . Functional capacity, risk factors, knowledge, and heart-health behaviors were maintained from 6 to 12 months in participants from both CR arms (all P>0.05). At 1 year, knowledge was significantly greater with comprehensive CR at either time point ( P<0.001). There were 2 deaths. Hospitalizations ( P=0.03), nonfatal myocardial infarctions ( P=0.04), and percutaneous coronary interventions ( P=0.03) were significantly fewer with CR than control at 6 months. Conclusions CR participation is associated with lower morbidity, long-term maintenance of functional capacity, risk factors, and heart-health behaviors, as well as with greater cardiovascular knowledge compared with no CR . Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 02575976.

Trial registration: ClinicalTrials.gov NCT02575976.

Keywords: cardiac rehabilitation; coronary disease; morbidity/mortality; rehabilitation; risk factor.

Figure 1

Study flow diagram. The threshold number of sessions for per‐protocol analysis was minimum of 24 of 36 exercise sessions (both CR arms) and an additional 16 of 24 education classes for comprehensive CR. CR indicates cardiac rehabilitation.

Figure 2

Mortality and morbidity by arm and time. The threshold number of sessions for per‐protocol analysis was minimum of 24of 36 exercise sessions (both CR arms) and an additional 16 of 24 education classes for CCR. Least significant difference post hoc: *^§ P<0.05; *^* P<0.01. CABG indicates coronary artery bypass grafting; CCR, comprehensive cardiac rehabilitation; CR, cardiac rehabilitation; CV, cardiovascular; Dept, department; MI, myocardial infarction; PCI, percutaneous coronary intervention.