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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VO2 peak test | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VO2 peak testing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) | Evaluated by changes in number of inappropriate shocks | 24 hours |
| Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Rune Wiseth, MD, Prof | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital | Trondheim | Norway |
Individual participant data for all primary and secondary outcome measures will be made available after deidentification and publication
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After publication
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
Evaluated by changes in stimulation threshold
| 24 hours |
| Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) | Evaluated by changes in lead impedance | 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 | 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 | 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 | 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 | Baseline and after 12 weeks |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |