BACKGROUND: There is a well-known correlation between obesity, sedentary lifestyle, and breast cancer incidence and outcome. The Arbeitsgemeinschaft Medikamentose Tumortherapie (AGMT) exercise study was a multicenter, randomized clinical trial and assessed the feasibility and efficacy of physical training in 50 breast cancer patients undergoing aromatase inhibitor treatment. METHODS: Postmenopausal, estrogen receptor-positive breast cancer patients under aromatase inhibitor treatment were randomized 1:1 to counseling and unsupervised training for 48 weeks (unsupervised arm) or counseling and a sequential training (supervised arm) with a supervised phase (24 weeks) followed by unsupervised physical training (further 24 weeks). Primary endpoint was the individual maximum power output on a cycle ergometer after 24 weeks of exercise. A key secondary endpoint was the feasibility of achieving 12 METh/week (metabolic equivalent of task hours per week). RESULTS: Twenty-three patients (92%) in the unsupervised arm and 19 patients (76%) in the supervised arm with early-stage breast cancer completed the study. After 24 weeks, the supervised arm achieved a significantly higher maximum output in watt (mean 132 +/- standard deviation (SD) 34; 95% confidence interval (CI) 117 to 147) compared to baseline (107 +/- 25; 95%CI 97 to 117; p = 0.012) with a numerically higher output than the unsupervised arm (week 24 115 +/- 25; 95%CI 105 to 125; p = 0.059). Significantly higher METh/week was reported in the supervised arm compared to the unsupervised arm during the whole study period (week 1 to 24 unsupervised: 18.3 (7.6 to 58.3); supervised: 28.5 (6.7 to 40.1); p = 0.043; week 25 to 48; p = 0.041)). CONCLUSION: This trial indicates that patients in an exercise program achieve higher fitness levels during supervised than unsupervised training.

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