Abstract
Limited data exist on heart rate stabilization in the domiciled nature of phase I clinical studies, particularly when frequent measurements of QT intervals are involved. The present analysis aimed to evaluate heart rate stability in the domiciled nature of, and stabilization after a short exercise. Fifty-six healthy male subjects were included in this analysis. Data during a domiciled clinical setting and after a short exercise were analysed. Mean values of 30 s intervals of collected electrocardiographical data (PR, RR, QT and QTcF intervals) during a 10-min supine resting period in a domiciled nature or after walking up and down three stories (100 steps) were compared to baseline values using paired t-tests or compared to the intrasubject standard deviation. Stable heart rates and stable QTcF intervals observed immediately upon assuming a supine position in the domiciled clinical setting. After the short exercise, PR interval and RR interval were significantly (p < 0.05) shorter for up to 120 s (mean value -9.8 ± 7.2 ms) and 30 s (-160 ± 165 ms, p < 0.05), respectively. QT and QTcF intervals were significantly (p < 0.05) shorter for up to 90 and 120 s postexercise, respectively. Both QT and QTcF intervals stabilized after 2 min, but QT interval remained prolonged while QTcF interval returned to baseline levels. In a clinical setting, male volunteers do not require a waiting period for electrocardiographic parameter normalization. However, accurate measurement of these parameters following a short exercise necessitates a minimum 2-min resting interval.
Published Version
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