TY - JOUR
T1 - Heart rate stability in a clinical setting and after a short exercise in healthy male volunteers
AU - Wildenbeest, Fleur W. H.
AU - Hassing, Gert-Jan
AU - Kemme, Michiel J. B.
AU - Moerland, Matthijs
AU - Gal, Pim
N1 - Publisher Copyright: © 2023 The Authors. Clinical Physiology and Functional Imaging published by John Wiley & Sons Ltd on behalf of Scandinavian Society of Clinical Physiology and Nuclear Medicine.
PY - 2024/1
Y1 - 2024/1
N2 - Introduction: 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. Methods: 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. Results: 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. Conclusion: 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.
AB - Introduction: 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. Methods: 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. Results: 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. Conclusion: 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.
KW - ECG
KW - QTcF interval
KW - RR interval
KW - electrophysiology
KW - repolarization
UR - http://www.scopus.com/inward/record.url?scp=85166919831&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/cpf.12846
DO - https://doi.org/10.1111/cpf.12846
M3 - Article
C2 - 37458374
SN - 1475-0961
VL - 44
SP - 36
EP - 43
JO - Clinical physiology and functional imaging
JF - Clinical physiology and functional imaging
IS - 1
ER -