Defibrillators, Implantable, Tachycardia, Ventricular
Conditions
Keywords
Exercise Training
Brief summary
This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.
Detailed description
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.
Interventions
BEHAVIORALVO2 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.
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with ICD and dilated cardiomyopathy or coronary heart disease as cause for implantation * ICD implanted at St Olavs hospital, Trondheim 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
* inability to accomplish the exercise program due to serious comorbidity or to participate in regular training within the next 3 months due to other reasons * signs of severe cardiac ischemia or persistent ventricular tachycardia during individualized treadmill O2 peak test, which after individual assessment is to be found at risk * comorbidity where endurance training at more than moderate intensity is discouraged * severe cardiac valve disease * planned surgery within the next 3 months * inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tendency for ventricular arrhythmia | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) | 24 hours | Evaluated by changes in number of inappropriate shocks |
| 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 | 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 |
Countries
Norway
Outcome results
None listed