St Olavs Hospital
Trondheim, Norway
NCT Number: NCT04075253
This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Trondheim, Norway
This study is a substudy of a planned study involving participants with an implantable cardioverter defibrillator (ICD), who will be randomly assigned to either take part in a exercise program for 12 weeks or serve as control and live as usual (Clinical Trials Unique Protocol ID: 2018/1592). In that study all participants will complete an exercise treadmill test to determine maximum oxygen uptake (VO2 peak).
In this study we wish to examine the acute effect of one single bout of high intensity exercise (i.e the VO2 peak test) on the tendency for ventricular arrhythmia. The study will evaluate changes in ICD-parameters and the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test.
The study will also examine if the acute effect after VO2 peak testing alters after completing 12 weeks of aerobic interval training or control respectively.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In case of difficulties with patient inclusion for the study, the criteria might be broadened to include patients with idiopathic ventricular arrhythmia as cause for implantation.
Exclusion criteria
Exercise on treadmill starts with ~4km/h at 0% inclination before inclination is increased to 4% and speed kept unchanged. Inclination will then be increased with two percent approximately after each minute until exhaustion.
Other names: Cardiopulmonary Exercise Testing (CPET)
Time frame: 24 hours
Measured by changes in the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test. Registered on a 72 hours Holter monitoring
Time frame: 24 hours
Evaluated by changes in number of inappropriate shocks
Time frame: 24 hours
Evaluated by changes in stimulation threshold
Time frame: 24 hours
Evaluated by changes in lead impedance
Time frame: 24 hours
Evaluated by changes in atrial and ventricular refractory period
Time frame: 24 hours
Evaluated by changes in restitution time of the sinus node
Time frame: 24 hours
Evaluated by changes in refractory period of the AV-node
Time frame: Baseline and after 12 weeks
Measured by changes in the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test. Registered on a 72 hours Holter monitoring
St. Olavs Hospital
Other
Acute Effect of One Single Bout of High Intensity Exercise. A Substudy of the Study on Physical Activity and Ventricular Arrhythmias
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