An interventional study of VO2 peak testing in Tachycardia, Ventricular and Defibrillators, Implantable, sponsored by St. Olavs Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Treatment
This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.
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.
443 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.
This study's enrollment of 55 is below the median of 64 across 269 interventional studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
All participants enrolled in the planned study on physical activity and ventricular arrhythmias and on baseline will complete an exercise treadmill test to determine VO2 peak
Behavioral: VO2 peak testing
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.
Also known as: Cardiopulmonary Exercise Testing (CPET)
Tendency for ventricular arrhythmia
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
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in number of inappropriate shocks
Time frame: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in stimulation threshold
Time frame: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in lead impedance
Time frame: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in atrial and ventricular refractory period
Time frame: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in restitution time of the sinus node
Time frame: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in refractory period of the AV-node
Time frame: 24 hours
Changes in acute effect of one single bout of high intensity exercise on tendency for ventricular arrhythmia after either 3 months of interval exercise or control
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: Baseline and after 12 weeks
Plan to share: Yes — Individual participant data for all primary and secondary outcome measures will be made available after deidentification and publication
Time frame: After publication
Access criteria: Not yet decided
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Sep 2022, 36 months.
Of 84 non-industry interventional studies with no phase under Tachycardia, Ventricular, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's 36 months is close to that.
Counting every sponsor, half of 121 studies reached it within 36 months; a quarter within 20 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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