Acute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia

St. Olavs Hospital

Status: Completed

Conditions: Defibrillators, Implantable; Tachycardia, Ventricular

Treatments: Behavioral: VO2 peak testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04075253

2018/1592-b

Details and patient eligibility

About

This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

VO2 peak test

Experimental group

Description:

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

Treatment:

Behavioral: VO2 peak testing