The EuroAction physical activity and fitness study: a paired, cluster-randomised controlled trial in 8 European countries in people with coronary heart disease and individuals

Abstract

Context: Increased physical activity participation and fitness are cardioprotective. The EUROACTION trial demonstrated that a preventive cardiology programme significantly increased self-reported physical activity participation (Wood et al., 2008). Objective: The EUROACTION Physical Activity and Fitness (EPAF) Study aimed to objectively evaluate the effectiveness of the EUROACTION physical activity and exercise intervention at increasing physical activity participation and fitness in people with coronary artery disease (COR) and those at high risk of developing cardiovascular disease (HRI) compared to standard care. Study design: A nested study within a paired cluster randomised controlled trial in eight European countries. Methodology: 12 pairs of centres (12 hospitals and 12 general practices) were randomised to receive the EUROACTION programme (INT) or be monitored for usual care (UC). In the INT hospitals, COR patients participated in a 16-week supervised exercise programme and a home-based activity intervention, delivered by a physiotherapist. In INT general practice nurses were trained to deliver personalised physical activity advice to HRI. Outcome measures: Objective physical activity participation was measured by mean number of steps per day (Yamax Digiwalker SW200 pedometer). Fitness was determined by the Incremental Shuttle Walk Test (ISWT) [hospital centres] and Chester Step Test (CST) [general practice centres]). Results: The mean number of steps in COR patients at 1–year was significantly higher in INT (+2310 steps, 95% CI +1226 to +3394 steps; P=0.003). The difference in cardiorespiratory fitness (ISWT) exceeded the minimal clinically important difference but was not statistically significant (+54 metres [95% CI - 102.8 to +211.0 metres]; P=0.42). In general practice centres, whilst no significant differences were found at 1 year in mean steps per day (+982 steps, 95% CI -569 to +2533 steps) and cardiorespiratory fitness (CST) at 1-year (+0.93 minutes, 95% CI -0.62 to +2.48 minutes), there was a difference in the change over time in fitness in favour of the INT (+0.94 mins [95% CI +0.23 to +1.66 mins]; P=0.02). Marked heterogeneity impacted on statistical power. All differences observed represented clinically important differences. Conclusion: The EPAF-Study has demonstrated that the EUROACTION programme was effective at increasing physical activity participation but objective measures indicate to a lesser degree than the self-reported physical activity outcomes previously published. Clinically important differences in objectively measured physical activity participation and cardiorespiratory fitness suggest further research, which is sufficiently powered, is warranted.